NDC 59316-206

Biofreeze Colorless Roll-On

Menthol

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

• Product ID: 59316-206_2c22ebec-9f44-0e8a-e054-00144ff8d46c
• NDC: 59316-206
• Product Type: Human Otc Drug
• Proprietary Name: Biofreeze Colorless Roll-On
• Generic Name: Menthol
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-01-17
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: Performance Health Inc.
• Substance Name: MENTHOL
• Active Ingredient Strength: 40 mg/mL
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 59316-206-10

1 BOTTLE, WITH APPLICATOR in 1 CARTON (59316-206-10) > 89 mL in 1 BOTTLE, WITH APPLICATOR

• Marketing Start Date: 2013-01-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59316-206-10 [59316020610]

Biofreeze Colorless Roll-On GEL

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-01-17

Drug Details

Active Ingredients

Ingredient	Strength
MENTHOL	40 mg/mL

OpenFDA Data

• SPL SET ID: a8d59d45-0e85-43d1-affd-bbe922c4acb1
• Manufacturer:
  • Performance Health Inc.
• UNII:
  • L7T10EIP3A
• RxNorm Concept Unique ID - RxCUI:
  • 415974
  • 1111683

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

NDC	Brand Name	Generic Name
59316-206	Biofreeze Colorless Roll-On	Biofreeze Colorless 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