FDA.reportPublic FDA data

Melatonin Rapid Release Gelcaps 10 mg

Manufacturer
Granules India Limited | Granules India Ltd
Effective date
2023-02-26
Label type
BULK INGREDIENT
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:35:33

Label at a glance#

ProductMelatonin Rapid Release Gelcaps 10 mg
Active ingredientMELATONIN
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

melatonin 10 mgmelatonin 10 mg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62207-79762207-797-38

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
POVIDONE K30U725QWY32XIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
HYPROMELLOSE 2910 (3 MPA.S)0VUT3PMY82IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
GELATIN2G86QN327LIACT
POLYETHYLENE GLYCOL 600030IQX730WEIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
SHELLAC46N107B71OIACT
ISOPROPYL ALCOHOLND2M416302IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
BUTYL ALCOHOL8PJ61P6TS3IACT
AMMONIA5138Q19F1XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
MELATONINJL5DK93RCLACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.