FDA.reportPublic FDA data

Biofreeze Professional Colorless

Product NDC
59316-116
11-digit product format
593160116
Labeler code
59316
Product ID
59316-116_51991b66-c6a4-c6d4-e063-6394a90a6f71
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, UNSPECIFIED FORM
Dosage form
GEL
Route
TOPICAL
Labeler
Reckitt Benckiser
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
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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-116-10Biofreeze Professional Colorless89 mL in 1 BOTTLEGEL8913
59316-116-11Biofreeze Professional Colorless3 mL in 1 PACKETGEL313
59316-116-20Biofreeze Professional Colorless118 mL in 1 TUBEGEL11813
59316-116-40Biofreeze Professional Colorless946 mL in 1 BOTTLEGEL94613

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-116-20ML - Milliliter59316-1169f98ba32-1370-4a3c-9d30-553c5dce5d7912024-03-12
59316-116-40ML - Milliliter59316-1160d9c7bdf-1499-4bc4-bf40-881d5058400712024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-116BIOFREEZE PROFESSIONAL COLORLESS (MENTHOL, UNSPECIFIED FORM) GEL [RB HEALTH (US) LLC]12Current NDC, Legacy NDC, 4 package rows20241228_4639201c-a67a-475f-8df6-3dc6225803ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1794892BIOFREEZE 5 % Topical GelPSN4639201c-a67a-475f-8df6-3dc6225803ad13
415975menthol 5 % Topical GelPSN4639201c-a67a-475f-8df6-3dc6225803ad13
1794892menthol 0.05 MG/MG Topical Gel [Biofreeze]SBD4639201c-a67a-475f-8df6-3dc6225803ad13
415975menthol 0.05 MG/MG Topical GelSCD4639201c-a67a-475f-8df6-3dc6225803ad13
1794892Biofreeze 5 % Topical GelSY4639201c-a67a-475f-8df6-3dc6225803ad13
415975menthol 5 % Topical GelSY4639201c-a67a-475f-8df6-3dc6225803ad13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59316-116-105931601161089 mL in 1 BOTTLE (59316-116-10) 89 ml2026-05-14NoNoHistorical
59316-116-11593160116113 mL in 1 PACKET3 mlHistorical
59316-116-2059316011620118 mL in 1 TUBE (59316-116-20) 118 ml2016-06-030000-00-00NoNoCurrent
59316-116-4059316011640946 mL in 1 BOTTLE (59316-116-40) 946 ml2016-06-030000-00-00NoNoCurrent