Application Nr Approved Date Route Status External Links
NDA021394 2005-12-21 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 (14 Total)

Name Structure Kind Function Status
1. Calcium Stearate CALCIUM STEARATE Molecular AC-Anticaking agent , AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous GRAS-Generally recognized as safe.
2. Carnauba Wax CARNAUBA WAX Unresolved MISC-Miscellaneous GRAS-Generally recognized as safe.
3. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
4. Starch, Corn STARCH, CORN Unresolved
5. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
6. Glyceryl Dibehenate GLYCERYL DIBEHENATE Unresolved
7. Hypromelloses HYPROMELLOSES Unresolved
8. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
9. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
10. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
11. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
12. 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.
13. Stearic Acid STEARIC ACID Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
14. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 2 Total)

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