Reference Source

Sarvotham Care Ltd · 66-41 · INDIA

For Sarvotham Care Ltd · 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 Sensodyne Fresh Gel | Sensodyne Fresh Mint Toothpaste | Sensodyne Fresh Gel | Sensodyne Fresh Mint Toothpaste | Sensodyne Fresh Gel | Sensodyne Fresh Mint Toothpaste | Sensodyne Fresh Gel | Sensodyne Fresh Mint Toothpaste | Sensodyne Fresh Mint Toothpaste | Sensodyne Fresh Gel; 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 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 63 R - - 04 Sodium Fluoride (Dental Caries Prophylactic) | 63 R - - 04 Sodium Fluoride (Dental Caries Prophylactic) | 63 R - - 06 Stannous Fluoride (Dental Caries Prophylactic) | 63 R - - 06 Stannous Fluoride (Dental Caries Prophylactic) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 05/19/2026; address is 739/597/11/2, behind napa paper mill, Jharmajri Village , Baddi, Barotiwala , Solan, Himachal Pradesh INDIA, verified against its source on 2026-09-16.

Firm
Sarvotham Care Ltd verified
Import alert
66-41
Import alert name
Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
Country
INDIA verified
Address
739/597/11/2, behind napa paper mill, Jharmajri Village , Baddi, Barotiwala , Solan, Himachal Pradesh INDIA verified
Date published
05/19/2026 verified
Product code
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 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 63 R - - 04 Sodium Fluoride (Dental Caries Prophylactic) | 63 R - - 04 Sodium Fluoride (Dental Caries Prophylactic) | 63 R - - 06 Stannous Fluoride (Dental Caries Prophylactic) | 63 R - - 06 Stannous Fluoride (Dental Caries Prophylactic) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
Product
Sensodyne Fresh Gel | Sensodyne Fresh Mint Toothpaste | Sensodyne Fresh Gel | Sensodyne Fresh Mint Toothpaste | Sensodyne Fresh Gel | Sensodyne Fresh Mint Toothpaste | Sensodyne Fresh Gel | Sensodyne Fresh Mint Toothpaste | Sensodyne Fresh Mint Toothpaste | Sensodyne Fresh Gel each item verified
FDA notes
This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling includes statements such as (not an all-inclusive list): “…protect against cavities”, “…Daily Sensitivity Protection” , “…Helps remove plaque”. | This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling includes statements such as (not an all-inclusive list): “…protect against cavities”, “…Daily Sensitivity Protection” , “…Helps remove plaque”. | This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling includes statements such as (not an all-inclusive list): “…protect against cavities”, “…Daily Sensitivity Protection” , “…Helps remove plaque”. | This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling includes statements such as (not an all-inclusive list): “…protect against cavities”, “…Daily Sensitivity Protection” , “…Helps remove plaque”. | This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling includes statements such as (not an all-inclusive list): “…protect against cavities”, “…Daily Sensitivity Protection” , “…Helps remove plaque”. | This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling includes statements such as (not an all-inclusive list): “…protect against cavities”, “…Daily Sensitivity Protection” , “…Helps remove plaque”. | This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling includes statements such as (not an all-inclusive list): “…protect against cavities”, “…Daily Sensitivity Protection” , “…Helps remove plaque”. | This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling includes statements such as (not an all-inclusive list): “…protect against cavities”, “…Daily Sensitivity Protection” , “…Helps remove plaque”. | This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling includes statements such as (not an all-inclusive list): “…protect against cavities”, “…Daily Sensitivity Protection” , “…Helps remove plaque”. | This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling includes statements such as (not an all-inclusive list): “…protect against cavities”, “…Daily Sensitivity Protection” , “…Helps remove plaque”. each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Sarvotham Care Ltd Date Published : 05/19/2026 739/597/11/2, behind napa paper mill, Jharmajri Village , Baddi, Barotiwala , Solan, Himachal Pradesh INDIA 53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products) Date Published: 05/19/2026 Desc: Sensodyne Fresh Gel Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling includes statements such as (not an all-inclusive list): “…protect against cavities”, “…Daily Sensitivity Protection” , “…Helps remove plaque”. 53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products) Date Published: 05/19/2026 Desc: Sensodyne Fresh Mint Toothpaste Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling includes statements such as (not an all-inclusive list): “…protect against cavities”, “…Daily Sensitivity Protection” , “…Helps remove plaque”. 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 05/19/2026 Desc: Sensodyne Fresh Gel Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling includes statements such as (not an all-inclusive list): “…protect against cavities”, “…Daily Sensitivity Protection” , “…Helps remove plaque”. 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 05/19/2026 Desc: Sensodyne Fresh Mint Toothpaste Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling includes statements such as (not an all-inclusive list): “…protect against cavities”, “…Daily Sensitivity Protection” , “…Helps remove plaque”. 63 R - - 04 Sodium Fluoride (Dental Caries Prophylactic) Date Published: 05/19/2026 Desc: Sensodyne Fresh Gel Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling includes statements such as (not an all-inclusive list): “…protect against cavities”, “…Daily Sensitivity Protection” , “…Helps remove plaque”. 63 R - - 04 Sodium Fluoride (Dental Caries Prophylactic) Date Published: 05/19/2026 Desc: Sensodyne Fresh Mint Toothpaste Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling includes statements such as (not an all-inclusive list): “…protect against cavities”, “…Daily Sensitivity Protection” , “…Helps remove plaque”. 63 R - - 06 Stannous Fluoride (Dental Caries Prophylactic) Date Published: 05/19/2026 Desc: Sensodyne Fresh Gel Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling includes statements such as (not an all-inclusive list): “…protect against cavities”, “…Daily Sensitivity Protection” , “…Helps remove plaque”. 63 R - - 06 Stannous Fluoride (Dental Caries Prophylactic) Date Published: 05/19/2026 Desc: Sensodyne Fresh Mint Toothpaste Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling includes statements such as (not an all-inclusive list): “…protect against cavities”, “…Daily Sensitivity Protection” , “…Helps remove plaque”. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 05/19/2026 Desc: Sensodyne Fresh Mint Toothpaste Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling includes statements such as (not an all-inclusive list): “…protect against cavities”, “…Daily Sensitivity Protection” , “…Helps remove plaque”. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 05/19/2026 Desc: Sensodyne Fresh Gel Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling includes statements such as (not an all-inclusive list): “…protect against cavities”, “…Daily Sensitivity Protection” , “…Helps remove plaque”.

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

Source

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