FDA.reportPublic FDA data

Biofreeze Professional

Product NDC
59316-120
11-digit product format
593160120
Labeler code
59316
Product ID
59316-120_51e08fc1-b046-088a-e063-6394a90ac4f3
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, UNSPECIFIED FORM
Dosage form
SPRAY
Route
TOPICAL
Labeler
Reckitt Benckiser LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-06-03
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
105 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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM105 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui1489073, 1489074

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-120-20Biofreeze Professional118 mL in 1 BOTTLESPRAY11812
59316-120-30Biofreeze Professional473 mL in 1 BOTTLESPRAY47312

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-120-20ML - Milliliter59316-120e8563207-5e09-4049-af1e-7dccdad6cf7712023-06-06
59316-120-30ML - Milliliter59316-1200c2db5f6-4de4-4dc8-ac44-21e4cafd3dcf12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-120BIOFREEZE PROFESSIONAL (MENTHOL, UNSPECIFIED FORM) SPRAY [RB HEALTH (US) LLC]11Current NDC, Legacy NDC, 2 package rows20241228_db982baf-31ea-4f09-90e3-cd5facb5dfe5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1489074BIOFREEZE 10.5 % Topical SprayPSNdb982baf-31ea-4f09-90e3-cd5facb5dfe512
1489073menthol 10.5 % Topical SprayPSNdb982baf-31ea-4f09-90e3-cd5facb5dfe512
1489074menthol 105 MG/ML Topical Spray [Biofreeze]SBDdb982baf-31ea-4f09-90e3-cd5facb5dfe512
1489073menthol 105 MG/ML Topical SpraySCDdb982baf-31ea-4f09-90e3-cd5facb5dfe512
1489074Biofreeze 10.5 % Topical SpraySYdb982baf-31ea-4f09-90e3-cd5facb5dfe512
1489074Biofreeze 105 MG/ML Topical SpraySYdb982baf-31ea-4f09-90e3-cd5facb5dfe512
1489073menthol 10.5 % Topical SpraySYdb982baf-31ea-4f09-90e3-cd5facb5dfe512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59316-120-2059316012020118 mL in 1 BOTTLE (59316-120-20) 118 ml2016-06-030000-00-00NoNoCurrent
59316-120-3059316012030473 mL in 1 BOTTLE (59316-120-30) 473 ml2016-06-030000-00-00NoNoCurrent