FDA.reportPublic FDA data

Melatonin

Manufacturer
Rising Pharma Holdings, Inc.
Effective date
2025-06-23
Label type
DIETARY SUPPLEMENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:51:51

Label at a glance#

ProductMelatonin
Active ingredientMelatonin
Label structure6 sections

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

Supplement Facts - 3 mg

supplement-factssupplement-facts

Supplement Facts - 5 mg

supplement-factssupplement-facts

HEALTH CLAIM SECTION

Other ingredients: Microcrystalline cellulose. Contains less than 2% of: coating (hypromellose, polyethylene glycol, hydroxypropyl cellulose), croscarmellose sodium, magnesium stearate, and silica.

DOSAGE & ADMINISTRATION SECTION

Directions: As a dietary supplement, take one tablet daily, 30 minutes before bedtime or as directed by your healthcare practitioner.

WARNINGS SECTION

Warning: Do not drive or operate machinery while taking this product. Pregnant or lactating women and persons using prescription drugs should consult their physician prior to using the product. Do not take if suffering from any autoimmune disorder.

warningwarning

SAFE HANDLING WARNING SECTION

  • Keep out of the reach of children.
  • Store at room temperature.
  • Protect from heat, light and moisture.
  • This unit dose container is not child resistant.

Questions or comments?

Call 1-844-474-7464

Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

3mg -  Revised: 03/2024

5mg - Revised: 10/2023

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Melatonin - 3 mg

Dietary Supplement

100 Tablets (10x10) Unit dose

Blister label (16571-872-90)

blister-label-3mgblister-label-3mg

Carton label (16571-872-01)

carton-label-3mgcarton-label-3mg

Melatonin - 5 mg

Dietary Supplement

100 Tablets (10x10) Unit dose

Blister label (16571-873-90)

blister-label-5mgblister-label-5mg

Carton label (16571-873-01)

carton-label-5mgcarton-label-5mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199163melatonin 3 MG Oral TabletPSN1
252732melatonin 5 MG Oral TabletPSN1
199163melatonin 3 MG Oral TabletSCD1
252732melatonin 5 MG Oral TabletSCD1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16571-872-01Melatonin10 in 1 CARTONTABLET101
16571-872-90Melatonin10 in 1 BLISTER PACKTABLET101
16571-873-01Melatonin10 in 1 CARTONTABLET101
16571-873-90Melatonin10 in 1 BLISTER PACKTABLET101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-872-01EA - Each16571-872ea6584c4-de0c-424b-99b0-e23ca0099c7c12025-08-11
16571-873-01EA - Each16571-873213f8e14-45f2-4ec1-bf77-481e52ed912212025-08-11

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
16571-87216571-872-90, 16571-872-01
16571-87316571-873-90, 16571-873-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
MelatoninJL5DK93RCLACTIB
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MAGNESIUM STEARATE70097M6I30IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MelatoninJL5DK93RCLACTIB
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MAGNESIUM STEARATE70097M6I30IACT
SILICON DIOXIDEETJ7Z6XBU4IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Melatonin 1527MELATONINProfessional Complementary Health Formulaseb411c99-fe69-400d-b452-95d8d6d754b82026-01-08WarningsName fallback
generic name: MELATONIN
MELATONIN CORDMELATONINEnergique, Inc.9a59554b-14c4-4c79-9db1-0a38b3c152f22024-10-28WarningsName fallback
generic name: MELATONIN
Melatonin PhenolicMELATONINEnergique, Inc.895cb8a5-33ea-4764-86a6-1da513dcd2c12024-10-28WarningsName fallback
generic name: MELATONIN
MelatoninMELATONINBioActive Nutritional, Inc.8951e5e9-5d8f-4808-b247-208760fae6562024-10-17WarningsName fallback
brand name: Melatonin
generic name: MELATONIN
MelatoninMELATONINDeseret Biologicals, Inc.4ea9b3dc-a6f7-48b0-b0a7-ac2951bc575d2024-04-01WarningsName fallback
brand name: Melatonin
generic name: MELATONIN
MelatoninMELATONINBioActive Nutritional, Inc.cd82eb5d-a44a-4512-ad65-0fffae70d1d02017-07-25WarningsName fallback
brand name: Melatonin
generic name: MELATONIN

Reported adverse events (FAERS/openFDA)#

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