Biofreeze Professional

Product NDC
50090-6367
11-digit product format
500906367
Labeler code
50090
Product ID
50090-6367_e2597670-90c0-42b1-a9be-97f043fcecff
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, UNSPECIFIED FORM
Dosage form
GEL
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-06-03
Substance
MENTHOL
Active strength
50 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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 Professional
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
415975Internal RxNorm lookup
1794892Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cbeac814-59d8-4c13-8e73-bca66f797f8dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6367-0Biofreeze Professional118 mL in 1 TUBEGEL1183

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6367-0ML - Milliliter50090-6367f4d9274b-5961-4844-9e84-5d72cdf7b02312023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6367BIOFREEZE PROFESSIONAL (MENTHOL, UNSPECIFIED FORM) GEL [A-S MEDICATION SOLUTIONS]3Current NDC, 1 package rows20250112_cbeac814-59d8-4c13-8e73-bca66f797f8d.zip

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 106 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrocortisoneHYDROCORTISONE 1%Pharmacy Value Alliance LLCab95e606-69f0-1d58-e053-2a95a90a073b2024-12-20WarningsExact identifier
application number: M017
Itch Relief CreamZINC ACETATE 0.1%, DIPHENHYDRAMINE HYDROCHLORIDE 2%Pharmacy Value Alliance LLC37fe6d82-adee-4f58-e054-00144ff88e882024-12-20WarningsExact identifier
application number: M017
Warrior First Aid Anti ItchDIPHENHYDRAMINE HCL 2%, ZINC ACETATE 0.1%Derma Care Research Labs, LLCec6e9a5b-c61d-a385-e053-2995a90ac9362024-12-20WarningsExact identifier
application number: M017
DCH Burn ReliefLIDOCAINE HCLDerma Care Research Labs, LLCff227154-cf3b-9796-e053-6294a90a55352024-12-20WarningsExact identifier
application number: M017
Outback Pain ReliefCAMPHOR 6%, MENTHOL 16%Derma Care Research Labs, LLCc238c930-2012-2d48-e053-2a95a90a8a4a2024-12-20WarningsExact identifier
application number: M017
Meijer Pain ReliefLIDOCAINE HCL 4%Meijerf31b11ed-2ff9-5cfc-e053-2a95a90af2ca2024-12-20WarningsExact identifier
application number: M017
Meijer Pain ReliefMENTHOL 10.5%Meijerbed81975-bd63-cf5b-e053-2995a90ac5fa2024-12-20WarningsExact identifier
application number: M017
Mirakel Pain and Itch ReliefBENZOCAINE 20%, RESORCINOL 3%Sanvio, Inc.ed34d728-0275-e209-e053-2995a90a93ff2024-12-20WarningsExact identifier
application number: M017
Meijer Pain ReliefLIDOCAINE 4%Meijerbed67c31-c479-6f9b-e053-2a95a90a55162024-12-20WarningsExact identifier
application number: M017
Blue-Emu Ultra with Hemp SeedTROLAMINE SALICYLATEKingsway Pharmaceuticals dba NFI, LLC80a3cf99-16e8-412b-ab9f-3d9d5cbb7aa92024-12-20WarningsExact identifier
application number: M017
Epsom SaltsMAGNESIUM SULFATEInternational Wholesale Inc.e4d9bc32-ac85-349f-e053-2995a90a032f2024-12-19WarningsExact identifier
application number: M017
Epsom SaltsMAGNESIUM SULFATEInternational Wholesale Inc.e5f3edc2-1b79-533a-e053-2a95a90ae9b62024-12-19WarningsExact identifier
application number: M017
LeaderLIDOCAINE HCLCardinal Healthcea6bd2d-a265-1209-e053-2995a90ab0a52024-12-19WarningsExact identifier
application number: M017
Rugby Anti-ItchCAMPHOR, MENTHOLRUGBY LABORATORIES99d8ad9e-46ec-15fc-e053-2995a90a0d172024-12-19WarningsExact identifier
application number: M017
DCH Calaspray Itch ReliefPRAMOXINE HCL 1%, ZINC ACETATE 0.1%Derma Care Research Labs, LLCfda2afaf-3cd0-92b3-e053-6394a90a74932024-12-19WarningsExact identifier
application number: M017
DCH Nerve Pain Relief Roll-OnLIDOCAINE HCL 4%, MENTHOL 1%Derma Care Research Labs, LLCff32cbb2-79eb-9158-e053-6394a90ac3572024-12-19WarningsExact identifier
application number: M017
DCH Burn ReliefLIDOCAINE, 0.5%Derma Care Research Labsffd7be08-0510-dfcb-e053-6394a90ad2862024-12-19WarningsExact identifier
application number: M017
DCH Arthritis Pain Relief Roll-OnCAPSAISIN 0.1%Derma Care Research Labs, LLCfda0d359-95eb-8b38-e053-6294a90a7b882024-12-19WarningsExact identifier
application number: M017
DCH Pain RelievingMENTHOL 2%Derma Care Research Labs, LLCff49ee63-6a87-c7a7-e053-6294a90a77a32024-12-19WarningsExact identifier
application number: M017
Warrior Pain Relief Roll-On Maximum StrengthLIDOCAINE HCL 4%Derma Care Research Labs, LLCdd80e560-6467-2166-e053-2995a90a88a82024-12-19WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1794892BIOFREEZE 5 % Topical GelPSNcbeac814-59d8-4c13-8e73-bca66f797f8d3
415975menthol 5 % Topical GelPSNcbeac814-59d8-4c13-8e73-bca66f797f8d3
1794892menthol 0.05 MG/MG Topical Gel [Biofreeze]SBDcbeac814-59d8-4c13-8e73-bca66f797f8d3
415975menthol 0.05 MG/MG Topical GelSCDcbeac814-59d8-4c13-8e73-bca66f797f8d3
1794892Biofreeze 5 % Topical GelSYcbeac814-59d8-4c13-8e73-bca66f797f8d3
415975menthol 5 % Topical GelSYcbeac814-59d8-4c13-8e73-bca66f797f8d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6367-050090636700118 mL in 1 TUBE (50090-6367-0) 118 ml2023-02-09NoNoCurrent