NDC 59316-119

Biofreeze Professional

Menthol, Unspecified Form

Biofreeze Professional is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Performance Health, Llc. The primary component is Menthol, Unspecified Form.

• Product ID: 59316-119_66b1314e-1e1f-d308-e053-2a91aa0a2cb0
• NDC: 59316-119
• Product Type: Human Otc Drug
• Proprietary Name: Biofreeze Professional
• Generic Name: Menthol, Unspecified Form
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2016-06-03
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: Performance Health, LLC
• Substance Name: MENTHOL, UNSPECIFIED FORM
• Active Ingredient Strength: 50 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 59316-119-20

118 mL in 1 TUBE, WITH APPLICATOR (59316-119-20)

• Marketing Start Date: 2016-06-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59316-119-20 [59316011920]

Biofreeze Professional GEL

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-06-03
• Marketing End Date: 2020-12-31

Drug Details

Active Ingredients

Ingredient	Strength
MENTHOL, UNSPECIFIED FORM	50 mg/mL

OpenFDA Data

• SPL SET ID: c28aeff9-3a77-4a51-80f0-775bd7543e06
• Manufacturer:
  • Performance Health, LLC
• UNII:
  • L7T10EIP3A
• RxNorm Concept Unique ID - RxCUI:
  • 1794892
  • 415975

NDC Crossover Matching brand name "Biofreeze Professional" or generic name "Menthol, Unspecified Form"

NDC	Brand Name	Generic Name
68071-4325	Biofreeze Professional	Biofreeze Professional
68071-4589	Biofreeze Professional	Biofreeze Professional
59316-115	Biofreeze Professional	Biofreeze Professional
59316-120	Biofreeze Professional	Biofreeze Professional
59316-119	Biofreeze Professional	Biofreeze Professional
51068-507	ActivOn Ultra Strength Arthritis	Menthol, Unspecified Form
58980-615	ARCTIC RELIEF	MENTHOL, UNSPECIFIED FORM
58980-618	ARCTIC RELIEF PAIN RELIEVING	MENTHOL, UNSPECIFIED FORM
58980-617	ARCTIC RELIEF ROLL ON	MENTHOL, UNSPECIFIED FORM
59316-005	Biofreeze Overnight Relief	Menthol, Unspecified Form
10157-3101	Blistex Odor Eaters Medicated Foot	MENTHOL, UNSPECIFIED FORM
55910-883	DG Health Cold n Hot Pain Relieving	menthol, unspecified form
55910-884	DG Health Cold Zone Pain Relieving	MENTHOL, UNSPECIFIED FORM
50066-410	Dragon Pain Relief	MENTHOL, UNSPECIFIED FORM
55882-6102	Hello	Menthol, Unspecified Form
55882-3499	Hello Naturally Fresh Antiseptic	MENTHOL, UNSPECIFIED FORM
41250-350	Meijer Maximum Strength Pain Relieving	menthol, unspecified form
50382-016	Muscle and Joint	Menthol, Unspecified Form
52000-072	Muscle Rub Pain Reliever Gel	MENTHOL, UNSPECIFIED FORM
0536-1061	Rugby Ice Blue	MENTHOL, UNSPECIFIED FORM
36800-894	TopCare Maximum Strength Pain Relieving	MENTHOL, UNSPECIFIED FORM
36800-290	TopCare Pain Relieving Roll-On	MENTHOL, UNSPECIFIED FORM
0363-4837	Walgreen Cool n Heat Maximum Strength Pain Relieving	MENTHOL, UNSPECIFIED FORM
0363-6330	Walgreens Ice Blue Pain Relieving	MENTHOL, UNSPECIFIED FORM
54273-002	ZIMS MAX FREEZE	MENTHOL, UNSPECIFIED FORM
54273-003	ZIMS MAX FREEZE	MENTHOL, UNSPECIFIED FORM
54273-004	ZIMS MAX FREEZE	MENTHOL, UNSPECIFIED FORM
54273-006	ZIMS MAX FREEZE	MENTHOL, UNSPECIFIED FORM
54273-007	ZIMS MAX FREEZE	MENTHOL, UNSPECIFIED FORM
54273-009	ZIMS MAX FREEZE	MENTHOL, UNSPECIFIED FORM