Biofreeze

Product NDC
59316-870
11-digit product format
593160870
Labeler code
59316
Product ID
59316-870_51b574d1-9ee5-b2aa-e063-6294a90a5a3f
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
2024-02-15
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
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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-870-10Biofreeze85 g in 1 JARCREAM858

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-870-10GM - Gram59316-8702dab596e-2e5c-4a5b-8d1d-8728f194255f12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-870BIOFREEZE (MENTHOL) CREAM [RB HEALTH (US) LLC]7Current NDC, 1 package rows20240215_10a8face-47da-ebbe-e063-6294a90a42fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2001133BIOFREEZE 10 % Topical CreamPSN10a8face-47da-ebbe-e063-6294a90a42fe8
253020menthol 10 % Topical CreamPSN10a8face-47da-ebbe-e063-6294a90a42fe8
2001133menthol 100 MG/ML Topical Cream [Biofreeze]SBD10a8face-47da-ebbe-e063-6294a90a42fe8
253020menthol 100 MG/ML Topical CreamSCD10a8face-47da-ebbe-e063-6294a90a42fe8
2001133Biofreeze 10 % Topical CreamSY10a8face-47da-ebbe-e063-6294a90a42fe8
2001133Biofreeze 100 MG/ML Topical CreamSY10a8face-47da-ebbe-e063-6294a90a42fe8
253020menthol 10 % Topical CreamSY10a8face-47da-ebbe-e063-6294a90a42fe8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59316-870-105931608701085 g in 1 JAR (59316-870-10) 85 g2024-02-15NoNoHistorical