Application Nr Approved Date Route Status External Links
NDA020402 2000-03-16 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purpose Pain Reliever

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. D&c Yellow No. 10 D&C YELLOW NO. 10 Molecular DYE-Dye
2. Fd&c Green No. 3 FD&C GREEN NO. 3 Molecular DYE-Dye
3. Fd&c Red No. 40 FD&C RED NO. 40 Molecular
4. Gelatin GELATIN Unresolved
5. Light Mineral Oil LIGHT MINERAL OIL Unresolved
6. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
7. Potassium Hydroxide POTASSIUM HYDROXIDE Molecular B&N-Buffer & neutralizing agent , MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
8. Water WATER Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Ibuprofen IBUPROFEN ZINC2647

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