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 29 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr.Harry COMFORT ZONE CreamLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% COMFORT ZONE CREAMJiangxi Yudexi Pharmaceutical Co., LTD4d32b89f-72e8-bc93-e063-6394a90a0bc82026-03-17WarningsExact identifier
application number: M017
MiloRod Ultra Muscle Rub Fast-Acting Pain ReliefCAPSAICIN, MENTHOLMilo Rod Import & Export, Inc.c3622dc3-0c05-47c9-b70b-4989467819062026-03-17WarningsExact identifier
application number: M017
Walgreens Burn PadBURN PADWalgreens3f8d7624-cf1e-1992-e063-6294a90a38062026-03-17Boxed warning, WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEMericon Industries8f351b04-8f6d-4353-9100-13a8a80d656a2026-03-17WarningsExact identifier
application number: M017
Shoe Pain ReliefLIDOCAINE HCI 4%Sole Amie0f2ccd5f-b9f4-40fc-b82f-173b0f19bf402026-03-16WarningsExact identifier
application number: M017
CVS Muscle BalmMENTHOL, CAMPHORCVS Health42796fc4-03be-3b02-e063-6394a90af2ab2026-03-16WarningsExact identifier
application number: M017
Crane Safety HydrocortisoneHYDROCORTISONECrane Safety LLC96d9527d-9bf7-ce82-e053-2995a90aff0c2026-03-16WarningsExact identifier
application number: M017
CVS Health Pain Relief FootMENTHOL, UNSPECIFIED FORMNATURAL ESSENTIALS, INC.0f646876-69d0-49db-ade2-2b3eb26dd3992026-03-16WarningsExact identifier
application number: M017
Walgreens Cold Therapy Pain Relief Foot CreamMENTHOLWalgreen Co.3bc8ece3-d555-3efb-e063-6394a90a19812026-03-16WarningsExact identifier
application number: M017
RICHTOFIT RAPID ACTIVE LEG AND FOOTMENTHOLRICHTOFIT LIMITED LIABILITY COMPANY4c357696-ca96-e6ad-e063-6294a90aaadb2026-03-16WarningsExact identifier
application number: M017
Xpect Stopain ClinicalMENTHOLCintas Corporation348e6062-b31e-435e-a153-6aa868b50efa2026-03-13WarningsExact identifier
application number: M017
DGH GREASELESS MUSCLE RUB ANALGESICMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATEDOLLAR GENERAL225abfe0-ec72-4667-96b2-7657e989672b2026-03-13WarningsExact identifier
application number: M017
CVS Professional Pain ReliefMENTHOLCVS Pharmacy48836a5b-0baa-b7ee-e063-6294a90ac12b2026-03-13WarningsExact identifier
application number: M017
Keeps Climax DelayLIDOCAINE HYDROCHLORIDECosco International, Inc.3bfd3173-2dac-40a9-aec3-982b1d47d8fa2026-03-12WarningsExact identifier
application number: M017
NanoX Pain RelievingMENTHOL, METHYL SALICYLATEMG Science Technologies LLC4cc38927-8a8c-2df3-e063-6294a90aa0c12026-03-12WarningsExact identifier
application number: M017
Hand SanitizerALCOHOLProStat First Aid4cd4c51c-88bb-3797-e063-6294a90a8f702026-03-12WarningsExact identifier
application number: M017
CVS Lidocaine Pain ReliefLIDOCAINE HYDROCHLORIDE, MENTHOLCVS Pharmacy48c045ae-56b5-62c2-e063-6394a90aaf442026-03-12WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONEProStat First Aid4cd62cba-075a-7448-e063-6394a90ab48d2026-03-12WarningsExact identifier
application number: M017
Medicated Pain Relief PatchCAMPHOR, MENTHOL, METHYL SALICYLATEKroger Company47cc4b05-a937-4624-bf41-85b8bd7c049e2026-03-12WarningsExact identifier
application number: M017
Lidocaine HCLLIDOCAINE HCLMatthias Therapeutics, LLC4cdb27b5-9178-0328-e063-6394a90a50b52026-03-12WarningsExact 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