FDA.reportPublic FDA data

Biofreeze Professional

Product NDC
59316-834
11-digit product format
593160834
Labeler code
59316
Product ID
59316-834_51e066bd-7c9d-326a-e063-6394a90a28b1
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, UNSPECIFIED FORM
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Reckitt Benckiser LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-01
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
105 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 Professional
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM105 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui1489073, 1489074

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-834-20Biofreeze Professional118 mL in 1 BOTTLEAEROSOL, SPRAY11815
59316-834-22Biofreeze Professional2 in 1 CARTONAEROSOL, SPRAY215

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-834BIOFREEZE PROFESSIONAL (MENTHOL, UNSPECIFIED FORM) AEROSOL, SPRAY [RB HEALTH (US) LLC]14Current NDC, 2 package rows20250207_00bba5d2-b0e0-701c-e063-6294a90a5741.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1489074BIOFREEZE 10.5 % Topical SprayPSN00bba5d2-b0e0-701c-e063-6294a90a574115
1489073menthol 10.5 % Topical SprayPSN00bba5d2-b0e0-701c-e063-6294a90a574115
1489074menthol 105 MG/ML Topical Spray [Biofreeze]SBD00bba5d2-b0e0-701c-e063-6294a90a574115
1489073menthol 105 MG/ML Topical SpraySCD00bba5d2-b0e0-701c-e063-6294a90a574115
1489074Biofreeze 10.5 % Topical SpraySY00bba5d2-b0e0-701c-e063-6294a90a574115
1489074Biofreeze 105 MG/ML Topical SpraySY00bba5d2-b0e0-701c-e063-6294a90a574115
1489073menthol 10.5 % Topical SpraySY00bba5d2-b0e0-701c-e063-6294a90a574115

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59316-834-2059316083420118 mL in 1 BOTTLE (59316-834-20) 118 ml2024-02-01NoNoCurrent
59316-834-22593160834222 BOTTLE in 1 CARTON (59316-834-22) / 118 mL in 1 BOTTLE (59316-834-20) 2 bottle2025-03-15NoNoCurrent