Application Nr Approved Date Route Status External Links
NDA021920 2006-02-17 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purposes Pain Reliever/fever Reducer

All Formulated Excipients (10 Total)

Name Structure Kind Function Status
1. Gelatin GELATIN Unresolved
2. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
3. Lactic Acid, Unspecified Form LACTIC ACID, UNSPECIFIED FORM Molecular
4. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
5. Polyethylene Glycol 600 POLYETHYLENE GLYCOL 600 Unresolved
6. Povidone K30 POVIDONE K30 Unresolved
7. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
8. Water WATER Molecular
9. Sorbitan SORBITAN Molecular
10. Sorbitol SORBITOL Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Naproxen Sodium NAPROXEN SODIUM ZINC105216

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