Biofreeze Professional

Product NDC
68071-4325
11-digit product format
680714325
Labeler code
68071
Product ID
68071-4325_1a3dd23e-1c5a-9d41-e063-6394a90a3455
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, UNSPECIFIED FORM
Dosage form
GEL
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-06-03
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
50 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Biofreeze Professional
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui415975, 1794892

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4325-4Biofreeze Professional120 mL in 1 TUBEGEL1206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4325BIOFREEZE PROFESSIONAL (MENTHOL, UNSPECIFIED FORM) GEL [NUCARE PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 1 package rows20240608_66ff9726-20da-688a-e053-2a91aa0a59ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1794892BIOFREEZE 5 % Topical GelPSN66ff9726-20da-688a-e053-2a91aa0a59ac6
415975menthol 5 % Topical GelPSN66ff9726-20da-688a-e053-2a91aa0a59ac6
1794892menthol 0.05 MG/MG Topical Gel [Biofreeze]SBD66ff9726-20da-688a-e053-2a91aa0a59ac6
415975menthol 0.05 MG/MG Topical GelSCD66ff9726-20da-688a-e053-2a91aa0a59ac6
1794892Biofreeze 5 % Topical GelSY66ff9726-20da-688a-e053-2a91aa0a59ac6
415975menthol 5 % Topical GelSY66ff9726-20da-688a-e053-2a91aa0a59ac6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4325-468071432504120 mL in 1 TUBE (68071-4325-4) 120 ml2018-03-090000-00-00NoNoCurrent