NDC 70983-004

Pain Release

Menthol

Pain Release is a Topical Granule in the Human Otc Drug category. It is labeled and distributed by Saje Natural Business Inc.. The primary component is Menthol.

• Product ID: 70983-004_2842feb5-d818-412b-9233-e53ddd49db72
• NDC: 70983-004
• Product Type: Human Otc Drug
• Proprietary Name: Pain Release
• Generic Name: Menthol
• Dosage Form: Granule
• Route of Administration: TOPICAL
• Marketing Start Date: 2016-10-16
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: Saje Natural Business Inc.
• Substance Name: MENTHOL
• Active Ingredient Strength: 2 mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 70983-004-05

300 g in 1 BOTTLE, PLASTIC (70983-004-05)

• Marketing Start Date: 2020-06-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70983-004-07 [70983000407]

Pain Release GRANULE

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-10-16

NDC 70983-004-06 [70983000406]

Pain Release GRANULE

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-10-16

Drug Details

Active Ingredients

Ingredient	Strength
MENTHOL	1.6 mg/g

OpenFDA Data

• SPL SET ID: 1ac2ed54-194c-4de2-8e7f-6e74ca32aa40
• Manufacturer:
  • Saje Natural Business Inc.
• UNII:
  • L7T10EIP3A

NDC Crossover Matching brand name "Pain Release" or generic name "Menthol"

NDC	Brand Name	Generic Name
69204-006	Pain Release	Pain Release
69204-007	Pain Release	Pain Release
69204-005	Pain Release	Pain Release
69204-008	Pain Release	Pain Release
69204-011	Pain Release	Pain Release
70983-006	Pain Release	Pain Release
70983-004	Pain Release	Pain Release
70983-007	Pain Release	Pain Release
70983-005	Pain Release	Pain Release
70983-010	Pain Release	Pain Release
0363-1071	Cherry Cough Drop	Menthol
0363-1086	Cherry Cough Drops	Menthol
0363-0150	Cool n Heat Patch for Arm, Neck and Leg	Menthol
0363-0152	Cool n Heat Patch for Back	Menthol
0363-1072	Honey Lemon Cough Drop	Menthol
0363-1087	Honey Lemon Cough Drop	Menthol
0219-0203	Humphreys Bendito Alcoholado	menthol
0363-1070	Menthol Cough Drop	menthol
0363-1084	Menthol Cough Drop	menthol
0067-2067	Mineral Ice	Menthol
0316-0226	Mineral Ice	Menthol
0316-0290	Mineral Ice Quick Dry Foam	Menthol
0363-0151	Pain Relieving Patch	Menthol
0363-1077	SF Honey Lemon Cough Drop	Menthol
0363-1085	SF Menthol Cough Drop	Menthol
0363-0043	Studio 35 Medicated Body	Menthol
0363-0864	Walgreens Cold Pain Relief	MENTHOL
0363-0874	Walgreens Cold Pain Relief	MENTHOL
0363-0966	Walgreens Sunburn Relief	Menthol