Biofreeze

Product NDC
59316-835
11-digit product format
593160835
Labeler code
59316
Product ID
59316-835_485c8fe8-339a-6559-e063-6394a90ae8ea
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
SPRAY
Route
TOPICAL
Labeler
RB Health (US) LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-20
Substance
MENTHOL
Active strength
130 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Biofreeze
Brand name suffix
Professional
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL130 mg/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-835-20BiofreezeProfessional118 mL in 1 BOTTLESPRAY11813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59316-835-2059316083520118 mL in 1 BOTTLE (59316-835-20) 118 ml2026-01-20NoNoHistorical