FDA.reportPublic FDA data

Biofreeze Professional Colorless Roll-On

Product NDC
59316-118
11-digit product format
593160118
Labeler code
59316
Product ID
59316-118_51993a5e-b316-10ee-e063-6294a90a4d72
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 Colorless 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
59316-118-05Biofreeze Professional Colorless Roll-On74 mL in 1 BOTTLEGEL7413
59316-118-10Biofreeze Professional Colorless Roll-On89 mL in 1 BOTTLEGEL8913

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-118-10ML - Milliliter59316-118085bdb7b-487b-4a66-9bbf-82ed2ffb127b12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-118BIOFREEZE PROFESSIONAL COLORLESS ROLL-ON (MENTHOL, UNSPECIFIED FORM) GEL [RB HEALTH (US) LLC]12Current NDC, Legacy NDC, 2 package rows20241228_bae9946a-4c68-4759-9fb3-0a61a7ad0eb7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1794892BIOFREEZE 5 % Topical GelPSNbae9946a-4c68-4759-9fb3-0a61a7ad0eb713
415975menthol 5 % Topical GelPSNbae9946a-4c68-4759-9fb3-0a61a7ad0eb713
1794892menthol 0.05 MG/MG Topical Gel [Biofreeze]SBDbae9946a-4c68-4759-9fb3-0a61a7ad0eb713
415975menthol 0.05 MG/MG Topical GelSCDbae9946a-4c68-4759-9fb3-0a61a7ad0eb713
1794892Biofreeze 5 % Topical GelSYbae9946a-4c68-4759-9fb3-0a61a7ad0eb713
415975menthol 5 % Topical GelSYbae9946a-4c68-4759-9fb3-0a61a7ad0eb713
1794892BIOFREEZE 5 % Topical GelPSNce392c4f-cc43-484d-9c49-18fa25e4e5e93
415975menthol 5 % Topical GelPSNce392c4f-cc43-484d-9c49-18fa25e4e5e93
1794892menthol 0.05 MG/MG Topical Gel [Biofreeze]SBDce392c4f-cc43-484d-9c49-18fa25e4e5e93
415975menthol 0.05 MG/MG Topical GelSCDce392c4f-cc43-484d-9c49-18fa25e4e5e93
1794892Biofreeze 5 % Topical GelSYce392c4f-cc43-484d-9c49-18fa25e4e5e93
415975menthol 5 % Topical GelSYce392c4f-cc43-484d-9c49-18fa25e4e5e93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59316-118-055931601180574 mL in 1 BOTTLE74 mlHistorical
59316-118-105931601181089 mL in 1 BOTTLE (59316-118-10) 89 ml2016-06-030000-00-00NoNoCurrent