NDC 70518-0068

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: 70518-0068_81b4d56f-1c6e-317f-e053-2991aa0ada4d
• NDC: 70518-0068
• Product Type: Human Otc Drug
• Proprietary Name: Biofreeze Roll-On
• Generic Name: Menthol
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2016-12-15
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: REMEDYREPACK INC.
• Substance Name: MENTHOL
• Active Ingredient Strength: 40 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 70518-0068-0

1 BOTTLE, WITH APPLICATOR in 1 CARTON (70518-0068-0) > 89 mL in 1 BOTTLE, WITH APPLICATOR

• Marketing Start Date: 2016-12-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-0068-0 [70518006800]

Biofreeze Roll-On GEL

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-12-15
• Marketing End Date: 2018-05-15

Drug Details

Active Ingredients

Ingredient	Strength
MENTHOL	40 mg/mL

OpenFDA Data

• SPL SET ID: 6fdd10ef-0a42-4908-9f44-89053f1aa1c3
• 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