Application Nr Approved Date Route Status External Links
ANDA074352 1995-11-17 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purpose Antidiarrheal

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Benzoic Acid BENZOIC ACID Molecular PRES-Chemical preservative GRAS-Generally recognized as safe.
2. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
3. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
4. Water WATER Molecular
5. Sodium Benzoate SODIUM BENZOATE Molecular
6. Sorbitol SORBITOL Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE ZINC537928

Comments