FDA.reportPublic FDA data

Biofreeze

Product NDC
59316-869
11-digit product format
593160869
Labeler code
59316
Product ID
59316-869_51b57dbf-f47d-e694-e063-6294a90a7388
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
2020-03-21
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
100 mg/g
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM100 mg/g

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
253020Internal RxNorm lookup
2001133Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a227213b-e89f-7144-e053-2a95a90a7e74Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-869-10Biofreeze85 g in 1 JARCREAM857

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-869-10GM - Gram59316-869d31686b4-0888-46f4-9710-127a75a01bb612022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-869BIOFREEZE (MENTHOL) CREAM [RB HEALTH (US) LLC]6Current NDC, Legacy NDC, 1 package rows20240112_a227213b-e89f-7144-e053-2a95a90a7e74.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 75 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coralite Capsaicin Heat Patch 2ctCAPSAICINUnited Exchange Corp.4128b1ac-f540-2611-e063-6294a90ac98b2025-10-08WarningsExact identifier
application number: M017
Ombre Men overtime wipesBENZOCAINESambria Pharmaceuticals, LLC405f23ca-99c1-4db4-aba1-2fd7f93f55ee2025-10-07WarningsExact identifier
application number: M017
Pain free IVLIDOCAINESambria Pharmaceuticals, LLC7aa4cb20-d452-417f-afdb-307df754ed752025-10-07WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONECVS PHARMACY, INCb3bdff5e-37fe-442a-a370-7b19799ea7812025-10-07WarningsExact identifier
application number: M017
HealthWise Pain Relief PatchMENTHOL, METHYL SALICYLATEVeridian Healthcareb65932fd-ee9f-4fa2-b842-01e0f54133c92025-10-07WarningsExact identifier
application number: M017
AREX SINSIN PASCAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDESinsin Pharmaceutical Co., Ltd.2013ea44-e2ea-4b36-bddb-7f64163284b62025-10-07WarningsExact identifier
application number: M017
SINSINPAS LIDOCAINE PAIN RELIEVINGLIDOCAINESinsin Pharmaceutical Co., Ltd.82c0a036-8750-5b3d-e053-2a91aa0a18152025-10-07WarningsExact identifier
application number: M017
SINSIN MULPASL-MENTHOL, METHYL SALICYLATE, DL-CAMPHOR, CHLORPHENIRAMINE MALEATE, THYMOLSinsin Pharmaceutical Co., Ltd.81baffcb-c08e-4616-e053-2a91aa0aaf152025-10-07WarningsExact identifier
application number: M017
Arex Sinsin PasCAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDESinsin Pharmaceutical Co., Ltd.a851854a-5dfe-4bd5-95f6-67c3f13f11872025-10-07WarningsExact identifier
application number: M017
Sinsinpas Arex Flex Gel Pain Relieving PatchL-MENTHOLSinsin Pharmaceutical Co., Ltd.1758ef9b-4fac-4066-e063-6394a90a8cc32025-10-07WarningsExact identifier
application number: M017
SINSINPAS CORN REMOVERSALICYLIC ACIDSinsin Pharmaceutical Co., Ltd.e2771dfc-ee57-553f-e053-2a95a90af2812025-10-07WarningsExact identifier
application number: M017
Feminine Anti-Itch CremeBENZOCAINE, RESORCINOLQuality Choice (CHAIN DRUG MARKETING ASSOCIATION)aa6cc963-dc60-5222-e053-2995a90acaf62025-10-06WarningsExact identifier
application number: M017
TheraCare 2% Diphenhydramine Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEVeridian Healthcare5999b677-63dd-49c6-b5b8-7b3c117ecc5c2025-10-06WarningsExact identifier
application number: M017
HealthWise Pain ReliefMENTHOLVeridian Healthcare06be5331-7a1e-4ab3-9f17-2d350bd4b8902025-10-02WarningsExact identifier
application number: M017
equate Burn ReliefLIDOCAINE HYDROCHLORIDEWalmart Inca90cbd92-80a5-4463-8152-b83165121a6f2025-10-02WarningsExact identifier
application number: M017
AsperFlex HOTCAMPHOR, MENTHOL, METHYL SALICYLATEAkron Pharma Inc.a6cb0656-8866-44ff-b40c-73655ff687212025-10-02WarningsExact identifier
application number: M017
AsperFlex Original Maximum StrengthMENTHOLAkron Pharma Inc.d766c61e-c48b-4aff-97b0-678159479e032025-10-02WarningsExact identifier
application number: M017
HealthWise Feminine Anti-Itch CreamBENZOCAINE, RESORCINOLVeridian Healthcare1f9110da-f448-8e20-e063-6294a90a42752025-10-02WarningsExact identifier
application number: M017
PROSTAT FIRST AID Burn Ease, 0.9gLIDOCAINEProStat First Aid LLCdc704403-e2aa-47f7-a7f4-f6afe1547ca82025-10-01WarningsExact identifier
application number: M017
PROSTAT FIRST AID Burn Ease, 0.9gLIDOCAINEProStat First Aid LLCe02558a9-fe2b-4f28-9fd3-7308f859d7592025-10-01WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2001133BIOFREEZE 10 % Topical CreamPSNa227213b-e89f-7144-e053-2a95a90a7e747
253020menthol 10 % Topical CreamPSNa227213b-e89f-7144-e053-2a95a90a7e747
2001133menthol 100 MG/ML Topical Cream [Biofreeze]SBDa227213b-e89f-7144-e053-2a95a90a7e747
253020menthol 100 MG/ML Topical CreamSCDa227213b-e89f-7144-e053-2a95a90a7e747
2001133Biofreeze 10 % Topical CreamSYa227213b-e89f-7144-e053-2a95a90a7e747
2001133Biofreeze 100 MG/ML Topical CreamSYa227213b-e89f-7144-e053-2a95a90a7e747
253020menthol 10 % Topical CreamSYa227213b-e89f-7144-e053-2a95a90a7e747

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59316-869-105931608691085 g in 1 JAR (59316-869-10) 85 g2020-03-210000-00-00NoNoCurrent