FDA.reportPublic FDA data

Biofreeze Foam

Product NDC
59316-991
11-digit product format
593160991
Labeler code
59316
Product ID
59316-991_51b59ff7-ac73-08c9-e063-6294a90aaa23
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
Reckitt Benckiser LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-27
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
70 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 Foam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM70 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
2274104Internal RxNorm lookup
2274107Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
890191e8-99ad-489c-8f21-2592f3d31936Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-991-10Biofreeze Foam88 mL in 1 BOTTLELIQUID887

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-991-10ML - Milliliter59316-99106978780-38f7-4680-895b-86d65416bb4012024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-991BIOFREEZE FOAM (MENTHOL) LIQUID [RB HEALTH (US) LLC]6Current NDC, Legacy NDC, 1 package rows20241228_890191e8-99ad-489c-8f21-2592f3d31936.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 31 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine Hydrochloride and Zinc AcetateDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATESTRATEGIC SOURCING SERVICES LLCec0c9602-35cc-4bb6-b853-794a8b5bf42e2026-03-03WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONE 1%PHARMACY CHOICE INC4cdfe8b6-c332-7bf8-e063-6394a90abaec2026-03-03WarningsExact identifier
application number: M017
HEEL PAIN RELIEF ROLL-ONLIDOCAINE AND MENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.4c06c4a4-557b-8bb1-e063-6294a90a91252026-03-02WarningsExact identifier
application number: M017
Sunburn ReliefLIDOCAINE HCL 0.5%Old East Main Co.49173ec8-c94a-44c9-8a13-0f4b01b96cd62026-03-02Warnings, Adverse reactionsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEOld East Main Co.6d87547f-bf4c-4dda-bd9d-32b576afd8052026-03-02Warnings, Adverse reactionsExact identifier
application number: M017
Still StandingMENTHOL, UNSPECIFIED FORMNatural Essentials Inc.66974aaf-c82f-4fe9-bfb3-3430b80ac9f22026-03-02WarningsExact identifier
application number: M017
Lightning Pain ReliefMENTHOLClinical Resolution Laboratory, Inc.80af21f5-dba8-42b0-8a65-ac5a94d83ca82026-03-02WarningsExact identifier
application number: M017
Icy Hot Lidocaine No-MessLIDOCAINE HYDROCHLORIDEChattem, Inc.347f9a18-8ab6-47d3-9610-5b4e9ca5d53a2026-03-02WarningsExact identifier
application number: M017
Gold Bond Maximum Strength Foot Pain ReliefLIDOCAINE HYDROCHLORIDEGold Bond Co LLC8e469076-2f5a-4de8-8d13-a38c072b9af82026-03-01WarningsExact identifier
application number: M017
HealthWise Pain Relief LidocaineLIDOCAINE HYDROCHLORIDEVeridian Healthcare48ecbab9-13e0-d0fa-e063-6294a90a6ff22026-02-28WarningsExact identifier
application number: M017
NUMBING CREAMSLIDOCAINEYongchun Lihui Trading Co., Ltd.3b5e1a74-5946-4f1f-e063-6394a90a404b2026-02-27WarningsExact identifier
application number: M017
Pain Relieving GelLIDOCAINE HYDROCHLORIDEChain Drug Marketing Associationb55b7253-2fd2-45cc-b94c-e92395ab0d2b2026-02-27Warnings, Adverse reactionsExact identifier
application number: M017
MEDISTIK PROFESSIONAL DUAL ACTIONMENTHOL, METHYL SALICYLATE, EUCALUPTUSNatureteq Inc.99c7f08a-ab14-4371-9147-189f75cb66332026-02-27WarningsExact identifier
application number: M017
Aloe Vera GelLIDOCAINE HCL, MENTHOLWalmart Inc.309dcf5b-7166-976a-e063-6394a90af9522026-02-27Warnings, Adverse reactionsExact identifier
application number: M017
ASYSTEM Radical Relief Gel Roll-OnMENTHOL, METHYL SALICYLATECosco International, Inc.7239733e-5510-4a63-96c3-dd88b4a431a32026-02-27WarningsExact identifier
application number: M017
Icy Hot Pro Pain Massaging BalmCAMPHOR AND MENTHOLChattem, Inc.09e2b0cb-5186-4f9c-b256-edaced4ca0142026-02-27WarningsExact identifier
application number: M017
Lidocaine Pain ReliefLIDOCAINE PAIN RELIEFPAI Holdings, LLC dba PAI Pharma963978de-8295-47ee-9b06-64c3521aa9942026-02-26WarningsExact identifier
application number: M017
Tommie Copper Cooling Roller Lavender ScentMENTHOL 4%Tommie Copper, Inc.4bbfd4d1-9036-bc20-e063-6394a90a3feb2026-02-26WarningsExact identifier
application number: M017
HQLSEY QUIT SMOKING PATCHESQUIT SMOKING PATCHESHansen Pharmaceutical Investment Co., Limited4ba317fb-714a-05cb-e063-6394a90a382f2026-02-25WarningsExact identifier
application number: M017
Advanced Pain Relief Cream With 5 % Natural MentholMENTHOLAllure Labs4bab9c43-86d4-dad2-e063-6394a90ac0952026-02-25WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2274107BIOFREEZE 7 % Topical FoamPSN890191e8-99ad-489c-8f21-2592f3d319367
2274104menthol 7 % Topical FoamPSN890191e8-99ad-489c-8f21-2592f3d319367
2274107menthol 70 MG/ML Topical Foam [Biofreeze]SBD890191e8-99ad-489c-8f21-2592f3d319367
2274104menthol 70 MG/ML Topical FoamSCD890191e8-99ad-489c-8f21-2592f3d319367
2274107Biofreeze 7 % Topical FoamSY890191e8-99ad-489c-8f21-2592f3d319367
2274107Biofreeze 70 MG/ML Topical FoamSY890191e8-99ad-489c-8f21-2592f3d319367
2274104menthol 7 % Topical FoamSY890191e8-99ad-489c-8f21-2592f3d319367

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59316-991-105931609911088 mL in 1 BOTTLE (59316-991-10) 88 ml2020-01-270000-00-00NoNoCurrent