Dabur India Limited (Unit-2) · 66-41 · INDIA

For Dabur India Limited (Unit-2) · 66-41 · INDIA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is INDIA; product is Red Paste for Teeth and Gums "Toothpaste" | Meswak Complete Oral Care Toothpaste | Red Paste For Teeth & Gums | Meswak Complete Oral Care Toothpaste | Red Paste for Teeth and Gums "Toothpaste" | Red Paste For Teeth & Gums | Dabur Chyawanprash Jeevanprash | Red Paste for Teeth and Gums "Toothpaste" | Red Paste for Teeth and Gums "Toothpaste" | Meswak Complete Oral Care Toothpaste | Red Paste For Teeth & Gums | Red Paste for Teeth and Gums "Toothpaste" | Red Paste for Teeth and Gums "Toothpaste" | Red Paste For Teeth & Gums | Red Paste for Teeth and Gums "Toothpaste" | Meswak Complete Oral Care Toothpaste; product code is 53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products) | 53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products) | 53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products) | 53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C. | 53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C. | 53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 63 R - - 06 Stannous Fluoride (Dental Caries Prophylactic) | 63 R - - 99 Dental Caries Prophylactic N.E.C. | 63 R - - -- Dental Caries Prophyl | 63 R - - -- Dental Caries Prophyl | 63 S - - 99 Dental Protectant N.E.C. | 63 U - - 99 Dentin Desensitizer N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 02/04/2020; address is Integrated Industrial Estate, Plot No 4, Sec-2, Pant Nagar, Distt. Udham Singh Nagar , Udham Singh Nagar, Uttaranchal INDIA, verified against its source on 2026-09-16.

What the source says

Dabur India Limited (Unit-2) Date Published : 02/04/2020 Integrated Industrial Estate, Plot No 4, Sec-2, Pant Nagar, Distt. Udham Singh Nagar , Udham Singh Nagar, Uttaranchal INDIA 53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products) Date Published: 01/27/2021 Desc: Red Paste for Teeth and Gums "Toothpaste" Notes: Product appears to be is a drug, as per section 201(g)(1) of the FDCA, 21U.S.C.321(g)(1), and an unapproved new drug, as per section 505(a) of the FDCA, 21U.S.C.355(a). Claims on LBL (21CFR201.128) include: "Fights 7 Dental Problems, Cavities, Bad Breath, Bleeding Gums, Toothache, Yellowing, Plaque, Germs...antiseptic and antibacterial properties...anti-inflammatory". Based on the claims, the product is a drug as defined by section 201(g)(1)(B) of the FDCA, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FDCA, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. OTC drug products intended for use as anticaries are subject to the final rule for Anticaries Drug Products for OTC Human Use (anticaries final rule), 21CFR355. However, it is not labeled or formulated in accordance with this final rule for the reasons explained below. Product is a four-way combination drug product because it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. The anticaries final rule does not permit a four-way combination drug product such as this product. Thus, as formulated and labeled, it does not comply with the final rule described above. Furthermore, we are not aware of sufficient evidence to show the product as formulated and labeled, is GRAS and effective. Therefore, it appears to be a new drug within the meaning of section 201(p) of the FDCA, 21U.S.C. 321(p). Under sections 505(a) and 301(d) of the FDCA, a new drug may not be introduced/delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Product is not the subject of an FDA-approved application. 3/23/2020 53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products) Date Published: 04/03/2020 Desc: Meswak Complete Oral Care Toothpaste Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'It is scientifically proven to help reduce tartar and plaque, fight germs and bacteria...'; 'Helps prevent tooth decay...'; 'Fights tartar and plaque...'; 'Effective protection against cavities...'; 'Fights tooth decay...'; 'Fights germs & bacteria...'; 'Gingival protection...'. 53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products) Date Published: 02/04/2020 Desc: Red Paste For Teeth & Gums 53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C. Date Published: 04/03/2020 Desc: Meswak Complete Oral Care Toothpaste Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'It is scientifically proven to help reduce tartar and plaque, fight germs and bacteria...'; 'Helps prevent tooth decay...'; 'Fights tartar and plaque...'; 'Effective protection against cavities...'; 'Fights tooth decay...'; 'Fights germs & bacteria...'; 'Gingival protection...'. 53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C. Date Published: 01/27/2021 Desc: Red Paste for Teeth and Gums "Toothpaste" Notes: Product appears to be is a drug, as per section 201(g)(1) of the FDCA, 21U.S.C.321(g)(1), and an unapproved new drug, as per section 505(a) of the FDCA, 21U.S.C.355(a). Claims on LBL (21CFR201.128) include: "Fights 7 Dental Problems, Cavities, Bad Breath, Bleeding Gums, Toothache, Yellowing, Plaque, Germs...antiseptic and antibacterial properties...anti-inflammatory". Based on the claims, the product is a drug as defined by section 201(g)(1)(B) of the FDCA, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FDCA, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. OTC drug products intended for use as anticaries are subject to the final rule for Anticaries Drug Products for OTC Human Use (anticaries final rule), 21CFR355. However, it is not labeled or formulated in accordance with this final rule for the reasons explained below. Product is a four-way combination drug product because it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. The anticaries final rule does not permit a four-way combination drug product such as this product. Thus, as formulated and labeled, it does not comply with the final rule described above. Furthermore, we are not aware of sufficient evidence to show the product as formulated and labeled, is GRAS and effective. Therefore, it appears to be a new drug within the meaning of section 201(p) of the FDCA, 21U.S.C. 321(p). Under sections 505(a) and 301(d) of the FDCA, a new drug may not be introduced/delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Product is not the subject of an FDA-approved application. 3/23/2020 53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C. Date Published: 02/04/2020 Desc: Red Paste For Teeth & Gums 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 01/27/2021 Desc: Dabur Chyawanprash Jeevanprash Notes: India 4/2/2012 63 R - - 06 Stannous Fluoride (Dental Caries Prophylactic) Date Published: 01/27/2021 Desc: Red Paste for Teeth and Gums "Toothpaste" Notes: Product appears to be is a drug, as per section 201(g)(1) of the FDCA, 21U.S.C.321(g)(1), and an unapproved new drug, as per section 505(a) of the FDCA, 21U.S.C.355(a). Claims on LBL (21CFR201.128) include: "Fights 7 Dental Problems, Cavities, Bad Breath, Bleeding Gums, Toothache, Yellowing, Plaque, Germs...antiseptic and antibacterial properties...anti-inflammatory". Based on the claims, the product is a drug as defined by section 201(g)(1)(B) of the FDCA, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FDCA, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. OTC drug products intended for use as anticaries are subject to the final rule for Anticaries Drug Products for OTC Human Use (anticaries final rule), 21CFR355. However, it is not labeled or formulated in accordance with this final rule for the reasons explained below. Product is a four-way combination drug product because it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. The anticaries final rule does not permit a four-way combination drug product such as this product. Thus, as formulated and labeled, it does not comply with the final rule described above. Furthermore, we are not aware of sufficient evidence to show the product as formulated and labeled, is GRAS and effective. Therefore, it appears to be a new drug within the meaning of section 201(p) of the FDCA, 21U.S.C. 321(p). Under sections 505(a) and 301(d) of the FDCA, a new drug may not be introduced/delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Product is not the subject of an FDA-approved application. 3/23/2020 63 R - - 99 Dental Caries Prophylactic N.E.C. Date Published: 01/27/2021 Desc: Red Paste for Teeth and Gums "Toothpaste" Notes: Product appears to be is a drug, as per section 201(g)(1) of the FDCA, 21U.S.C.321(g)(1), and an unapproved new drug, as per section 505(a) of the FDCA, 21U.S.C.355(a). Claims on LBL (21CFR201.128) include: "Fights 7 Dental Problems, Cavities, Bad Breath, Bleeding Gums, Toothache, Yellowing, Plaque, Germs...antiseptic and antibacterial properties...anti-inflammatory". Based on the claims, the product is a drug as defined by section 201(g)(1)(B) of the FDCA, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FDCA, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. OTC drug products intended for use as anticaries are subject to the final rule for Anticaries Drug Products for OTC Human Use (anticaries final rule), 21CFR355. However, it is not labeled or formulated in accordance with this final rule for the reasons explained below. Product is a four-way combination drug product because it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. The anticaries final rule does not permit a four-way combination drug product such as this product. Thus, as formulated and labeled, it does not comply with the final rule described above. Furthermore, we are not aware of sufficient evidence to show the product as formulated and labeled, is GRAS and effective. Therefore, it appears to be a new drug within the meaning of section 201(p) of the FDCA, 21U.S.C. 321(p). Under sections 505(a) and 301(d) of the FDCA, a new drug may not be introduced/delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Product is not the subject of an FDA-approved application. 3/23/2020 63 R - - -- Dental Caries Prophyl Date Published: 04/03/2020 Desc: Meswak Complete Oral Care Toothpaste Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'It is scientifically proven to help reduce tartar and plaque, fight germs and bacteria...'; 'Helps prevent tooth decay...'; 'Fights tartar and plaque...'; 'Effective protection against cavities...'; 'Fights tooth decay...'; 'Fights germs & bacteria...'; 'Gingival protection...'. 63 R - - -- Dental Caries Prophyl Date Published: 02/04/2020 Desc: Red Paste For Teeth & Gums 63 S - - 99 Dental Protectant N.E.C. Date Published: 01/27/2021 Desc: Red Paste for Teeth and Gums "Toothpaste" Notes: Product appears to be is a drug, as per section 201(g)(1) of the FDCA, 21U.S.C.321(g)(1), and an unapproved new drug, as per section 505(a) of the FDCA, 21U.S.C.355(a). Claims on LBL (21CFR201.128) include: "Fights 7 Dental Problems, Cavities, Bad Breath, Bleeding Gums, Toothache, Yellowing, Plaque, Germs...antiseptic and antibacterial properties...anti-inflammatory". Based on the claims, the product is a drug as defined by section 201(g)(1)(B) of the FDCA, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FDCA, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. OTC drug products intended for use as anticaries are subject to the final rule for Anticaries Drug Products for OTC Human Use (anticaries final rule), 21CFR355. However, it is not labeled or formulated in accordance with this final rule for the reasons explained below. Product is a four-way combination drug product because it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. The anticaries final rule does not permit a four-way combination drug product such as this product. Thus, as formulated and labeled, it does not comply with the final rule described above. Furthermore, we are not aware of sufficient evidence to show the product as formulated and labeled, is GRAS and effective. Therefore, it appears to be a new drug within the meaning of section 201(p) of the FDCA, 21U.S.C. 321(p). Under sections 505(a) and 301(d) of the FDCA, a new drug may not be introduced/delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Product is not the subject of an FDA-approved application. 3/23/2020 63 U - - 99 Dentin Desensitizer N.E.C. Date Published: 01/27/2021 Desc: Red Paste for Teeth and Gums "Toothpaste" Notes: Product appears to be is a drug, as per section 201(g)(1) of the FDCA, 21U.S.C.321(g)(1), and an unapproved new drug, as per section 505(a) of the FDCA, 21U.S.C.355(a). Claims on LBL (21CFR201.128) include: "Fights 7 Dental Problems, Cavities, Bad Breath, Bleeding Gums, Toothache, Yellowing, Plaque, Germs...antiseptic and antibacterial properties...anti-inflammatory". Based on the claims, the product is a drug as defined by section 201(g)(1)(B) of the FDCA, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FDCA, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. OTC drug products intended for use as anticaries are subject to the final rule for Anticaries Drug Products for OTC Human Use (anticaries final rule), 21CFR355. However, it is not labeled or formulated in accordance with this final rule for the reasons explained below. Product is a four-way combination drug product because it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. The anticaries final rule does not permit a four-way combination drug product such as this product. Thus, as formulated and labeled, it does not comply with the final rule described above. Furthermore, we are not aware of sufficient evidence to show the product as formulated and labeled, is GRAS and effective. Therefore, it appears to be a new drug within the meaning of section 201(p) of the FDCA, 21U.S.C. 321(p). Under sections 505(a) and 301(d) of the FDCA, a new drug may not be introduced/delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Product is not the subject of an FDA-approved application. 3/23/2020 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 02/04/2020 Desc: Red Paste For Teeth & Gums 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/27/2021 Desc: Red Paste for Teeth and Gums "Toothpaste" Notes: Product appears to be is a drug, as per section 201(g)(1) of the FDCA, 21U.S.C.321(g)(1), and an unapproved new drug, as per section 505(a) of the FDCA, 21U.S.C.355(a). Claims on LBL (21CFR201.128) include: "Fights 7 Dental Problems, Cavities, Bad Breath, Bleeding Gums, Toothache, Yellowing, Plaque, Germs...antiseptic and antibacterial properties...anti-inflammatory". Based on the claims, the product is a drug as defined by section 201(g)(1)(B) of the FDCA, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FDCA, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. OTC drug products intended for use as anticaries are subject to the final rule for Anticaries Drug Products for OTC Human Use (anticaries final rule), 21CFR355. However, it is not labeled or formulated in accordance with this final rule for the reasons explained below. Product is a four-way combination drug product because it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. The anticaries final rule does not permit a four-way combination drug product such as this product. Thus, as formulated and labeled, it does not comply with the final rule described above. Furthermore, we are not aware of sufficient evidence to show the product as formulated and labeled, is GRAS and effective. Therefore, it appears to be a new drug within the meaning of section 201(p) of the FDCA, 21U.S.C. 321(p). Under sections 505(a) and 301(d) of the FDCA, a new drug may not be introduced/delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Product is not the subject of an FDA-approved application. 3/23/2020 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 04/03/2020 Desc: Meswak Complete Oral Care Toothpaste Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'It is scientifically proven to help reduce tartar and plaque, fight germs and bacteria...'; 'Helps prevent tooth decay...'; 'Fights tartar and plaque...'; 'Effective protection against cavities...'; 'Fights tooth decay...'; 'Fights germs & bacteria...'; 'Gingival protection...'.

— accessdata.fda.gov, retrieved 2026-09-15

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html

Last verified against source: 2026-09-16. Due for re-check by 2026-11-15. This page as Markdown · OKF bundle · full dataset as JSON.