# DABUR INDIA LIMITED · 66-41 · INDIA — FDA import alert red lists: firms subject to detention without physical examination

For DABUR INDIA LIMITED · 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 Hajmola Regular (Digestive Tablets/Candy) | Hajmola Regular (Digestive Tablets/Candy) | Hajmola Regular (Digestive Tablets/Candy) | Hajmola Regular (Digestive Tablets/Candy) | Hajmola Regular (Digestive Tablets/Candy); product code is 33 - - - -- Candy W/O Chocolate/Candy Specialties/Chewing Gums | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 60 S - - 99 Antacid, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 08/26/2025; address is 45 46 47 Plot No 44 , And 97; Smart Industrial Park , Pithampur, Madhya Pradesh INDIA, verified against its source on 2026-09-16.

- **Firm:** DABUR INDIA LIMITED _(verified: appears in the quote below)_
- **Import alert:** 66-41
- **Import alert name:** Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- **Country:** INDIA _(verified: appears in the quote below)_
- **Address:** 45 46 47 Plot No 44 , And 97; Smart Industrial Park , Pithampur, Madhya Pradesh INDIA _(verified: appears in the quote below)_
- **Date published:** 08/26/2025 _(verified: appears in the quote below)_
- **Product code:** 33 - - - -- Candy W/O Chocolate/Candy Specialties/Chewing Gums | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 60 S - - 99 Antacid, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. _(verified: each item appears in the quote below)_
- **Product:** Hajmola Regular (Digestive Tablets/Candy) | Hajmola Regular (Digestive Tablets/Candy) | Hajmola Regular (Digestive Tablets/Candy) | Hajmola Regular (Digestive Tablets/Candy) | Hajmola Regular (Digestive Tablets/Candy) _(verified: each item appears in the quote below)_
- **FDA notes:** 5/4/2006 | 5/4/2006 _(also on this page, in the second passage quoted below)_

## What the source says

> DABUR INDIA LIMITED Date Published : 08/26/2025 45 46 47 Plot No 44 , And 97; Smart Industrial Park , Pithampur, Madhya Pradesh INDIA 33 - - - -- Candy W/O Chocolate/Candy Specialties/Chewing Gums Date Published: 08/26/2025 Desc: Hajmola Regular (Digestive Tablets/Candy) Notes: 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 08/26/2025 Desc: Hajmola Regular (Digestive Tablets/Candy) Notes: 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 08/26/2025 Desc: Hajmola Regular (Digestive Tablets/Candy) Notes: 60 S - - 99 Antacid, N.E.C. Date Published: 08/26/2025 Desc: Hajmola Regular (Digestive Tablets/Candy) Notes: 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 08/26/2025 Desc: Hajmola Regular (Digestive Tablets/Candy) Notes:

## The same source also states

> Dabur India Limited Date Published : 09/13/2019 P.O. Daburgram , Bihar, INDIA 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 09/13/2019 Desc: Ayurvedic Notes: 5/4/2006 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 09/13/2019 Desc: Ayurvedic Notes: 5/4/2006

Source: https://www.accessdata.fda.gov/cms_ia/importalert_190.html

## The same source also states

> Dabur India Limited Date Published : 11/01/2021 SP -C 162 , Matsya Industrial Area , Alwar, Rajasthan INDIA 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 11/01/2021 Desc: Dabur Giloy Churna Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “Ayurvedic Medicine” Indications:” … useful for gout and arthritis, and helps purify blood”. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 11/01/2021 Desc: Dabur Giloy Churna Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “Ayurvedic Medicine” Indications:” … useful for gout and arthritis, and helps purify blood”. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 11/01/2021 Desc: Dabur Giloy Churna Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “Ayurvedic Medicine” Indications:” … useful for gout and arthritis, and helps purify blood”.

Source: https://www.accessdata.fda.gov/cms_ia/importalert_190.html

## The same source also states

> Dabur India Limited Date Published : 11/22/2010 60 Maiku Majra , Malku Majra Road; Nalagarth Road , Baddi, Himachal Pradesh INDIA 53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products) Date Published: 11/22/2010 Desc: Dabur Meswak Toothpaste Notes: India 53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C. Date Published: 11/22/2010 Desc: Dabur Meswak Toothpaste Notes: India 63 R - - 06 Stannous Fluoride (Dental Caries Prophylactic) Date Published: 11/22/2010 Desc: Dabur Meswak Toothpaste Notes: India 63 S - - 99 Dental Protectant N.E.C. Date Published: 11/22/2010 Desc: Dabur Meswak Toothpaste Notes: India

Source: https://www.accessdata.fda.gov/cms_ia/importalert_190.html

## The same source also states

> Dabur India Limited Date Published : 06/13/2013 Village Billanwali Lavana, Baddi , Solan, Himachal Pradesh INDIA 53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products) Date Published: 06/13/2013 Desc: Meswak toothpaste with pure extract of rare herb 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 01/27/2021 Desc: Fairness Creme Bleach Notes: 06/13/2013 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 01/27/2021 Desc: Fairness Creme Bleach with gulabari Notes: 6/13/2013

Source: https://www.accessdata.fda.gov/cms_ia/importalert_190.html

## The same source also states

> Dabur India Limited Date Published : 10/14/2012 225 - 4 - 1 Saily Village , Survey No , Dadra And Nagar Haveli, Dadra and Nagar Haveli And Dam INDIA 53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products) Date Published: 05/16/2025 Desc: Antiplaque & Whitening Toothpaste Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): “antiplaque & whitening…”. 53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products) Date Published: 10/14/2012 Desc: Dabur Red Paste for Gum Toothpaste 53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C. Date Published: 10/14/2012 Desc: Dabur Red Paste for Gum Toothpaste 53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C. Date Published: 05/16/2025 Desc: Antiplaque & Whitening Toothpaste Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): “antiplaque & whitening…”. 63 R - - 06 Stannous Fluoride (Dental Caries Prophylactic) Date Published: 10/14/2012 Desc: Dabur Red Paste for Gum Toothpaste 63 R - - 99 Dental Caries Prophylactic N.E.C. Date Published: 05/16/2025 Desc: Antiplaque & Whitening Toothpaste Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): “antiplaque & whitening…”. 63 S - - 99 Dental Protectant N.E.C. Date Published: 10/14/2012 Desc: Dabur Red Paste for Gum Toothpaste 63 U - - 99 Dentin Desensitizer N.E.C. Date Published: 10/14/2012 Desc: Dabur Red Paste for Gum Toothpaste 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 05/16/2025 Desc: Antiplaque & Whitening Toothpaste Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): “antiplaque & whitening…”. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 10/14/2012 Desc: Dabur Red Paste for Gum Toothpaste

Source: https://www.accessdata.fda.gov/cms_ia/importalert_190.html

## The same source also states

> Dabur India Limited Date Published : 05/29/2014 86 A, Kheda Industrial Area, Pithampur , Dhar, Madhya Pradesh INDIA 53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products) Date Published: 05/29/2014 Desc: Dabur RED TOOTHPOWDER for Healthy Gums & Strong Teeth

Source: https://www.accessdata.fda.gov/cms_ia/importalert_190.html

## The same source also states

> Dabur India Limited Date Published : 02/04/2020 Sanitpur , Garaimari, Assam INDIA 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: 02/04/2020 Desc: Red Paste For Teeth & Gums 63 R - - -- Dental Caries Prophyl Date Published: 02/04/2020 Desc: Red Paste For Teeth & Gums 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 02/04/2020 Desc: Red Paste For Teeth & Gums

Source: https://www.accessdata.fda.gov/cms_ia/importalert_190.html

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_190.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).