Biofreeze

Product NDC
59316-122
11-digit product format
593160122
Labeler code
59316
Product ID
59316-122_511848da-e35d-2343-e063-6294a90ae321
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Capsaicin, Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
Reckitt Benckiser LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-01
Substance
CAMPHOR (NATURAL); CAPSAICIN; MENTHOL, UNSPECIFIED FORM
Active strength
60; .5; 100 mg/mL; mg/mL; 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
Brand name suffix
Triple Target Gel
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (NATURAL)60 mg/mL
CAPSAICIN.5 mg/mL
MENTHOL, UNSPECIFIED FORM100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN20HL7Q941, S07O44R1ZM, L7T10EIP3A
Rxcui2741687

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-122-33BiofreezeTriple Target Gel89 mL in 1 BOTTLEGEL892
59316-122-33BiofreezeTriple Target Gel1 in 1 CARTONGEL12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2741687camphor 6 % / capsaicin 0.05 % / menthol 10 % Topical GelPSN511852c8-7428-3234-e063-6394a90a5bc22
2741687camphor 0.06 MG/MG / capsaicin 0.0005 MG/MG / menthol 0.1 MG/MG Topical GelSCD511852c8-7428-3234-e063-6394a90a5bc22
2741687camphor 6 % / capsaicin 0.05 % / menthol 10 % Topical GelSY511852c8-7428-3234-e063-6394a90a5bc22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59316-122-33593160122331 BOTTLE in 1 CARTON (59316-122-33) / 89 mL in 1 BOTTLE1 bottle2026-05-01NoNoCurrent