Application Nr Approved Date Route Status External Links
NDA022032 2007-12-04 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purpose Acid Reducer

All Formulated Excipients (14 Total)

Name Structure Kind Function Status
1. Carnauba Wax CARNAUBA WAX Unresolved MISC-Miscellaneous GRAS-Generally recognized as safe.
2. Ferric Oxide Red FERRIC OXIDE RED Molecular
3. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular
4. Hypromelloses HYPROMELLOSES Unresolved
5. Hypromellose Acetate Succinate HYPROMELLOSE ACETATE SUCCINATE Unresolved
6. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
7. Monoethanolamine MONOETHANOLAMINE Molecular MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
8. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
9. 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.
10. Sodium Stearate SODIUM STEARATE Molecular MISC-Miscellaneous , STAB-Stabilizer PS-Substances for which prior sanction has been granted by FDA for specific uses.
11. Sodium Stearyl Fumarate SODIUM STEARYL FUMARATE Molecular MISC-Miscellaneous , STAB-Stabilizer REG-Food additives for which a petition has been filed and a regulation issued.
12. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
13. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
14. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Omeprazole OMEPRAZOLE ZINC4693575

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