NDC 68788-6457

Biofreeze

Menthol

Biofreeze is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Preferred Pharmaceuticals Inc.. The primary component is Menthol, Unspecified Form.

• Product ID: 68788-6457_9b38841f-22ae-4518-b915-0f90e179d020
• NDC: 68788-6457
• Product Type: Human Otc Drug
• Proprietary Name: Biofreeze
• Generic Name: Menthol
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2016-08-16
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: Preferred Pharmaceuticals Inc.
• Substance Name: MENTHOL, UNSPECIFIED FORM
• Active Ingredient Strength: 40 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 68788-6457-1

118 mL in 1 BOTTLE (68788-6457-1)

• Marketing Start Date: 2016-08-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68788-6457-1 [68788645701]

Biofreeze GEL

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-08-16
• Marketing End Date: 2019-06-20

Drug Details

Active Ingredients

Ingredient	Strength
MENTHOL, UNSPECIFIED FORM	40 mg/mL

OpenFDA Data

• SPL SET ID: df86cbc0-b5a7-452b-8f2f-0af5ed2db0d9
• Manufacturer:
  • Preferred Pharmaceuticals Inc.
• UNII:
  • L7T10EIP3A
• RxNorm Concept Unique ID - RxCUI:
  • 415974
  • 1111683

NDC Crossover Matching brand name "Biofreeze" or generic name "Menthol"

NDC	Brand Name	Generic Name
68788-6457	Biofreeze	Biofreeze
59316-102	BIOFREEZE	BIOFREEZE
59316-993	Biofreeze	Biofreeze
59316-101	Biofreeze	Biofreeze
59316-104	Biofreeze	Biofreeze
59316-114	Biofreeze	Biofreeze
59316-869	Biofreeze	Biofreeze
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