FDA.reportPublic FDA data

Biofreeze

Product NDC
59316-104
Requested package NDC
59316-104-30
11-digit product format
593160104
Labeler code
59316
Product ID
59316-104_51b427be-af9f-1fbe-e063-6394a90acada
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
SPRAY
Route
TOPICAL
Labeler
Reckitt Benckiser LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-11-01
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
100 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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/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
667889Internal RxNorm lookup
1043232Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5edddb99-6596-4a3b-b361-1cc04d032c31Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-104-10Biofreeze59 mL in 1 BOTTLE, SPRAYSPRAY5940
59316-104-20Biofreeze118 mL in 1 BOTTLE, SPRAYSPRAY11840
59316-104-25Biofreeze118 mL in 1 BOTTLE, SPRAYSPRAY11840
59316-104-30Biofreeze473 mL in 1 BOTTLE, SPRAYSPRAY47340

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ABIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]24
MENTHOLACTIVE MOIETYL7T10EIP3ABIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]24
ALCOHOLINACTIVE INGREDIENT3K9958V90MBIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]24
ARNICA MONTANAINACTIVE INGREDIENTO80TY208ZWBIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]24
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YDBIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]24
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XBIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]24
DIMETHYL SULFOXIDEINACTIVE INGREDIENTYOW8V9698HBIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]24
ECHINACEA, UNSPECIFIEDINACTIVE INGREDIENT4N9P6CC1DXBIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]24
ILEX PARAGUARIENSIS LEAFINACTIVE INGREDIENT1Q953B4O4FBIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]24
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSBIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]24
JUNIPERUS COMMUNIS WHOLEINACTIVE INGREDIENT464910T5N9BIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]24
WATERINACTIVE INGREDIENT059QF0KO0RBIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-104BIOFREEZE (MENTHOL) SPRAY [RB HEALTH (US) LLC]38Current NDC, Legacy NDC, 4 package rows20240110_5edddb99-6596-4a3b-b361-1cc04d032c31.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 1 of 154 · 3,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Jakwork Numbing CreamNUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5911d9b0-1acb-3546-e063-6294a90adb3a2026-08-15WarningsExact identifier
application number: M017
RVDU WARMING PAIN RELIEFCAPSAICINQIRUI NETWORK (SHENZHEN) CO., LTD.58eb2a86-bf25-d4b5-e063-6394a90af8c42026-08-13WarningsExact identifier
application number: M017
JJ Care First Aid BurnBENZALKONIUM CHLORIDE, LIDOCAINE HCINantong Health & Beyond Hygienic Products Inc.c41621fb-c549-4394-a4cb-cb81ef8c98df2026-08-13WarningsExact identifier
application number: M017
JJ CareHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.c88fa151-f8a8-4de2-98c9-71319bf53e362026-08-13WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONESafetec of America, Inc.da2b3b2c-11e0-401b-bbd2-d019271d1b3d2026-08-13WarningsExact identifier
application number: M017
CVS Pain Relief Roll-On Lidocaine with LavenderLIDOCAINE HYDROCHLORIDECVS Pharmacy4aa53176-2103-b47b-e063-6394a90ac7352026-08-12WarningsExact identifier
application number: M017
JUST CBD SOOTHINGMENTHOL, CAMPHORJust Brands LLC5384e80f-c242-76a1-e063-6294a90aba0b2026-08-12WarningsExact identifier
application number: M017
RELIBONEOintmentTOPICAL ANALGESICOINTMENTGuangdong Jiaoyu Biotechnology Co., Ltd58ddaaf6-18ec-8c5b-e063-6294a90a28282026-08-12WarningsExact identifier
application number: M017
Capsaicin CreamCAPSAICINTrifecta Pharmaceuticals USA LLC58de3a29-2bec-6e44-e063-6394a90a9c1a2026-08-12WarningsExact identifier
application number: M017
Muscle Rub CreamMUSCLE RUBALLIED TRADE LINK LLC11d33e60-8c64-4316-a29a-d17e3e6e4a282026-08-11WarningsExact identifier
application number: M017
Dr. Scholls Blister Pain Relief Complete KitLIDOCAINEScholl's Wellness Company LLC58c2b35c-e1ed-7ea8-e063-6294a90a14942026-08-11WarningsExact identifier
application number: M017
Arctic Ice Pain Relieving GelMENTHOLONEST LIMITEDc63ef7a5-d649-4fba-9361-d37f1150e21d2026-08-11WarningsExact identifier
application number: M017
Gee GasonMALE GENITAL DESENSITIZERMon Gars Boutique Inc58c75e5c-b801-017f-e063-6394a90a1c752026-08-11WarningsExact identifier
application number: M017
Capsaicin CreamCAPSAICINTrifecta Pharmaceuticals USA LLC58c84330-15bf-c397-e063-6394a90aba052026-08-11WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONETARGET Corporation4a140b9a-0e3c-4b50-b9c0-9e72616bb7d52026-08-11WarningsExact identifier
application number: M017
Medicated BODYMENTHOLCVS Pharmacy, Inc.a0f61498-69c8-4ce0-bbd7-3a807f192d362026-08-11WarningsExact identifier
application number: M017
Muscle MoveMENTHOLSaje Natural Wellness Inc.526d3305-4cf8-2fc5-e063-6394a90ad53b2026-08-10WarningsExact identifier
application number: M017
CVS Pain ReliefMENTHOLCVS Pharmacy4aa629f5-8b8f-cc67-e063-6394a90a019f2026-08-07WarningsExact identifier
application number: M017
Instant Cooling Itch ReliefHYDROCORTISONECVS Pharmacy46545d04-5958-d136-e063-6394a90a34622026-08-07WarningsExact identifier
application number: M017
CVS Itch ReliefPRAMOXINE HYDROCHLORIDE, ZINC ACETATECVS Pharmacy46921bea-fcbe-94d6-e063-6394a90a726b2026-08-07WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043232BIOFREEZE 10 % Topical SprayPSN5edddb99-6596-4a3b-b361-1cc04d032c3140
667889menthol 10 % Topical SprayPSN5edddb99-6596-4a3b-b361-1cc04d032c3140
1043232menthol 100 MG/ML Topical Spray [Biofreeze]SBD5edddb99-6596-4a3b-b361-1cc04d032c3140
667889menthol 100 MG/ML Topical SpraySCD5edddb99-6596-4a3b-b361-1cc04d032c3140
1043232Biofreeze 10 % Topical SpraySY5edddb99-6596-4a3b-b361-1cc04d032c3140
1043232Biofreeze 100 MG/ML Topical SpraySY5edddb99-6596-4a3b-b361-1cc04d032c3140
667889menthol 10 % Topical SpraySY5edddb99-6596-4a3b-b361-1cc04d032c3140

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59316-104-3059316010430473 mL in 1 BOTTLE, SPRAY (59316-104-30) 473 ml2016-08-250000-00-00NoNoCurrent