Application Nr Approved Date Route Status External Links
NDA018989 1984-05-18 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purpose Pain Reliever/fever Reducer

All Formulated Excipients (16 Total)

Name Structure Kind Function Status
1. Diacetylated Monoglycerides DIACETYLATED MONOGLYCERIDES Unresolved
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Starch, Corn STARCH, CORN Unresolved
4. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
5. Methylparaben METHYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
6. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
7. Shellac SHELLAC Unresolved
8. Povidones POVIDONES Unresolved
9. Propylparaben PROPYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
10. Sodium Benzoate SODIUM BENZOATE Molecular
11. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
12. Stearic Acid STEARIC ACID Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
13. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.
14. Synthetic Iron Oxides SYNTHETIC IRON OXIDES Unresolved
15. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
16. White Wax WHITE WAX Unresolved

Active Ingredients ( 1 Total)

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

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