Application Nr Approved Date Route Status External Links
ANDA090619 2009-07-08 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purposes Nighttime Sleep-Aid Pain Reliever

All Formulated Excipients (11 Total)

Name Structure Kind Function Status
1. Carnauba Wax CARNAUBA WAX Unresolved MISC-Miscellaneous GRAS-Generally recognized as safe.
2. Starch, Corn STARCH, CORN Unresolved
3. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
4. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
5. Fd&c Blue No. 2 FD&C BLUE NO. 2 Molecular DYE-Dye
6. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
7. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
8. Polyethylene Glycol 400 POLYETHYLENE GLYCOL 400 Unresolved
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. Stearic Acid STEARIC ACID Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
11. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 2 Total)

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