FDA.reportPublic FDA data

Biofreeze

Product NDC
59316-208
11-digit product format
593160208
Labeler code
59316
Product ID
59316-208_522e54c1-580e-1a06-e063-6294a90a4d71
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
2026-04-24
Substance
CAPSAICIN; CAMPHOR (NATURAL); MENTHOL, UNSPECIFIED FORM
Active strength
.5; 60; 100 mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Biofreeze
Brand name suffix
Triple Target Roll-On
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S07O44R1ZMInternal UNII lookup
N20HL7Q941Internal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2741687Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5089c088-3026-233a-e063-6394a90a93b6Available on FDA.report

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
59316-208-33BiofreezeTriple Target Roll-On74 mL in 1 BOTTLEGEL742
59316-208-33BiofreezeTriple Target Roll-On1 in 1 CARTONGEL12

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 63 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEKroger3f881349-fcdd-e276-e063-6394a90ae49e2025-11-13WarningsExact identifier
application number: M017
Rapid ReliefPLANTAR FASCIITIS PAIN RELIEF LIDOCAINE 4% MENTHOL 1%RAPID AID VIET NAM COMPANY LIMITED434cb8b2-a996-5360-e063-6394a90ada032025-11-13WarningsExact identifier
application number: M017
Rapid ReliefCOLD RELIEF PATCH 5% MENTHOLRAPID AID VIET NAM COMPANY LIMITED4360e3ec-7a4b-b28e-e063-6294a90a0bd62025-11-13WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH CAMPHOR 110MG MENTHOL 33MG CAPSICUM EXTRACT 22MGRAPID AID VIET NAM COMPANY LIMITED4360e3be-0ec4-cd57-e063-6394a90aca632025-11-13WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH LIDOCAINE 4% MENTHOL 1%RAPID AID VIET NAM COMPANY LIMITED43616ad7-58bb-e5ad-e063-6394a90a192b2025-11-13WarningsExact identifier
application number: M017
4x Medicated Severe Toothache and Gum GelBENZALKONIUM CHLORIDEMeijer97ce7890-5093-1763-e053-2a95a90afae72025-11-13WarningsExact identifier
application number: M017
Pain RelieverCAMPHOR, MENTHOLKool 'N Fit Inc.2253f6bd-5707-b993-e063-6394a90aa74a2025-11-13WarningsExact identifier
application number: M017
Rapid ReliefPLANTAR FASCIITIS PAIN RELIEF LIDOCAINE 4% MENTHOL 1%RAPID AID VIET NAM COMPANY LIMITED4360e0d1-46cd-ab4b-e063-6394a90a55e12025-11-12WarningsExact identifier
application number: M017
CVS Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATECVS8723e097-296f-784a-e053-2991aa0a552e2025-11-12WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAmericanna Wellness, Inc.154d8821-3e76-b0e2-e063-6294a90ae0772025-11-12WarningsExact identifier
application number: M017
Good neighbor Pharmacy Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEAMERISOURCEBERGEN DRUG CORPORATION87395273-380c-7cef-e053-2991aa0a54c62025-11-12WarningsExact identifier
application number: M017
Quality Choice Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEChain Drug Marketing Association8735b298-83f3-0b5d-e053-2a91aa0a82922025-11-12WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAmericanna Wellness, Inc.1550e794-b3c0-4769-e063-6294a90a8c2d2025-11-12WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAmericanna Wellness, Inc.154fd46e-f00d-1772-e063-6394a90aba7d2025-11-12WarningsExact identifier
application number: M017
Best Choice Itch StoppingDIPHENHYDRAMINE HCLValu Merchandisers884cfd64-2cd1-8c12-e053-2995a90a89252025-11-12WarningsExact identifier
application number: M017
Itch StoppingDIPHENHYDRAMINE HCLCVS8839149d-e6d5-57cc-e053-2995a90a98322025-11-12WarningsExact identifier
application number: M017
Itch StoppingDIPHENHYDRAMINE HCLChain Drug Marketing Association884c9b47-d511-1d17-e053-2995a90a42eb2025-11-12WarningsExact identifier
application number: M017
Painless Tattoo 1BENZOCAINESambria Pharmaceuticals, LLC2f8fdcac-b87a-4191-9504-480a473f95cc2025-11-12WarningsExact identifier
application number: M017
Painless Tattoo 2LIDOCAINESambria Pharmaceuticals, LLC180b2899-7699-40e2-974a-081a6ce2bca22025-11-12WarningsExact identifier
application number: M017
Painless Tattoo 3TETRACAINESambria Pharmaceuticals, LLC9c24dcff-3988-40eb-821a-fd4b0c85f5282025-11-12WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2741687camphor 6 % / capsaicin 0.05 % / menthol 10 % Topical GelPSN5089c088-3026-233a-e063-6394a90a93b62
2741687camphor 0.06 MG/MG / capsaicin 0.0005 MG/MG / menthol 0.1 MG/MG Topical GelSCD5089c088-3026-233a-e063-6394a90a93b62
2741687camphor 6 % / capsaicin 0.05 % / menthol 10 % Topical GelSY5089c088-3026-233a-e063-6394a90a93b62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59316-208-33593160208331 BOTTLE in 1 CARTON (59316-208-33) / 74 mL in 1 BOTTLE1 bottle2026-04-24NoNoCurrent