Biofreeze Professional Roll-On

Product NDC
59316-117
11-digit product format
593160117
Labeler code
59316
Product ID
59316-117_51e09cee-5dd5-65f6-e063-6394a90a2c67
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, UNSPECIFIED FORM
Dosage form
GEL
Route
TOPICAL
Labeler
Reckitt Benckiser LLC
Application
M017
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui415975, 1794892

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-117-10Biofreeze Professional Roll-On89 mL in 1 BOTTLEGEL8910

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-117BIOFREEZE PROFESSIONAL ROLL-ON (MENTHOL, UNSPECIFIED FORM) GEL [RB HEALTH (US) LLC]9Current NDC, Legacy NDC, 1 package rows20241228_f62f8ec3-593d-480a-85a0-01fcd7f1790c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1794892BIOFREEZE 5 % Topical GelPSNf62f8ec3-593d-480a-85a0-01fcd7f1790c10
415975menthol 5 % Topical GelPSNf62f8ec3-593d-480a-85a0-01fcd7f1790c10
1794892menthol 0.05 MG/MG Topical Gel [Biofreeze]SBDf62f8ec3-593d-480a-85a0-01fcd7f1790c10
415975menthol 0.05 MG/MG Topical GelSCDf62f8ec3-593d-480a-85a0-01fcd7f1790c10
1794892Biofreeze 5 % Topical GelSYf62f8ec3-593d-480a-85a0-01fcd7f1790c10
415975menthol 5 % Topical GelSYf62f8ec3-593d-480a-85a0-01fcd7f1790c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59316-117-105931601171089 mL in 1 BOTTLE (59316-117-10) 89 ml2016-06-030000-00-00NoNoCurrent