NDC 70518-0485

Biofreeze Roll-On

Menthol

Biofreeze Roll-On is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Menthol.

• Product ID: 70518-0485_5f8f8f79-d159-5d4e-e053-2991aa0ad74e
• NDC: 70518-0485
• Product Type: Human Otc Drug
• Proprietary Name: Biofreeze Roll-On
• Generic Name: Menthol
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2017-05-05
• Marketing Category: OTC MONOGRAPH N / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: REMEDYREPACK INC.
• Substance Name: MENTHOL
• Active Ingredient Strength: 40 mg/mL
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 70518-0485-0

74 mL in 1 BOTTLE (70518-0485-0)

• Marketing Start Date: 2017-05-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-0485-0 [70518048500]

Biofreeze Roll-On GEL

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-05-05

Drug Details

Active Ingredients

Ingredient	Strength
MENTHOL	40 mg/mL

OpenFDA Data

• SPL SET ID: 4a13b1dc-e5fc-4fe7-b6d5-3c5b14ac21ac
• Manufacturer:
  • REMEDYREPACK INC.
• UNII:
  • L7T10EIP3A
• RxNorm Concept Unique ID - RxCUI:
  • 415974
  • 1111683

NDC Crossover Matching brand name "Biofreeze Roll-On" or generic name "Menthol"

NDC	Brand Name	Generic Name
70518-0068	Biofreeze Roll-On	Biofreeze Roll-On
70518-0485	Biofreeze Roll-On	Biofreeze Roll-On
59316-205	Biofreeze Roll-On	Biofreeze Roll-On
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