FDA.reportPublic FDA data

Biofreeze Foot Cream

Product NDC
59316-001
11-digit product format
593160001
Labeler code
59316
Product ID
59316-001_51b57c01-885b-f5b1-e063-6294a90a75e9
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
CREAM
Route
TOPICAL
Labeler
Reckitt Benckiser LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-12
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
100 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Biofreeze Foot Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM100 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui253020, 2001133

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-001-10Biofreeze Foot Pain Relief Set85 g in 1 TUBECREAM85 g100 mg in 1g6
59316-001-10Biofreeze Foot Cream85 g in 1 TUBECREAM855
59316-001-20Biofreeze Foot Cream113.3 g in 1 TUBECREAM113.35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-001BIOFREEZE FOOT PAIN RELIEF SET (MENTHOL) KIT [RB HEALTH (US) LLC]5Current NDC, Legacy NDC20241228_4a885eef-0364-4655-bccc-7158c76cc5b2.zip
59316-001BIOFREEZE FOOT CREAM (MENTHOL) CREAM [RB HEALTH (US) LLC]4Current NDC, Legacy NDC, 2 package rows20241228_32450cbf-4ed4-402b-a30e-e08a17bba3fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2001133BIOFREEZE 10 % Topical CreamPSN4a885eef-0364-4655-bccc-7158c76cc5b26
253020menthol 10 % Topical CreamPSN4a885eef-0364-4655-bccc-7158c76cc5b26
2001133menthol 100 MG/ML Topical Cream [Biofreeze]SBD4a885eef-0364-4655-bccc-7158c76cc5b26
253020menthol 100 MG/ML Topical CreamSCD4a885eef-0364-4655-bccc-7158c76cc5b26
2001133Biofreeze 10 % Topical CreamSY4a885eef-0364-4655-bccc-7158c76cc5b26
2001133Biofreeze 100 MG/ML Topical CreamSY4a885eef-0364-4655-bccc-7158c76cc5b26
253020menthol 10 % Topical CreamSY4a885eef-0364-4655-bccc-7158c76cc5b26
2001133BIOFREEZE 10 % Topical CreamPSN32450cbf-4ed4-402b-a30e-e08a17bba3fb5
253020menthol 10 % Topical CreamPSN32450cbf-4ed4-402b-a30e-e08a17bba3fb5
2001133menthol 100 MG/ML Topical Cream [Biofreeze]SBD32450cbf-4ed4-402b-a30e-e08a17bba3fb5
253020menthol 100 MG/ML Topical CreamSCD32450cbf-4ed4-402b-a30e-e08a17bba3fb5
2001133Biofreeze 10 % Topical CreamSY32450cbf-4ed4-402b-a30e-e08a17bba3fb5
2001133Biofreeze 100 MG/ML Topical CreamSY32450cbf-4ed4-402b-a30e-e08a17bba3fb5
253020menthol 10 % Topical CreamSY32450cbf-4ed4-402b-a30e-e08a17bba3fb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59316-001-105931600011085 g in 1 TUBE (59316-001-10) 85 g2021-03-120000-00-00NoNoCurrent
59316-001-2059316000120113.3 g in 1 TUBE (59316-001-20) 113.3 g2021-03-120000-00-00NoNoCurrent