FDA.reportPublic FDA data

Biofreeze Colorless

Product NDC
59316-103
Requested package NDC
59316-103-40
11-digit product format
593160103
Labeler code
59316
Product ID
59316-103_51b597cc-8068-e160-e063-6394a90ac1be
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Reckitt Benckiser LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-01-03
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
40 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 Colorless
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM40 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
415974Internal RxNorm lookup
1111683Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
939dbbc3-71ec-4990-840e-7c9b8d430562Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-103-10Biofreeze Colorless5 mL in 1 BOTTLEGEL531
59316-103-11Biofreeze Colorless3 mL in 1 BOTTLEGEL331
59316-103-12Biofreeze Colorless89 mL in 1 BOTTLEGEL8931
59316-103-15Biofreeze Colorless89 mL in 1 BOTTLE, WITH APPLICATORGEL8931
59316-103-20Biofreeze Colorless118 mL in 1 BOTTLEGEL11831
59316-103-28Biofreeze Colorless273 mL in 1 BOTTLEGEL27331
59316-103-40Biofreeze Colorless946 mL in 1 BOTTLEGEL94631

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-103-12ML - Milliliter59316-103b52397a8-ed9d-4dc6-b82e-39964b2d6c6a12018-05-09
59316-103-20ML - Milliliter59316-103700d69bb-759b-4ca7-941b-78f7b222594012024-06-10
59316-103-40ML - Milliliter59316-1030770d763-3f20-4da3-91bb-9cc65a6fddcf12024-08-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ABIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
MENTHOLACTIVE MOIETYL7T10EIP3ABIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XBIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0BIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
ARCTIUM LAPPA ROOTINACTIVE INGREDIENT597E9BI3Z3BIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
ARNICA MONTANA FLOWERINACTIVE INGREDIENTOZ0E5Y15PZBIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YDBIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
CAMPHOR (SYNTHETIC)INACTIVE INGREDIENT5TJD82A1ETBIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
FRANKINCENSEINACTIVE INGREDIENTR9XLF1R1WMBIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0BIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
ILEX PARAGUARIENSIS LEAFINACTIVE INGREDIENT1Q953B4O4FBIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302BIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSBIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
MELISSA OFFICINALIS LEAFINACTIVE INGREDIENT50D2ZE9219BIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKBIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
WATERINACTIVE INGREDIENT059QF0KO0RBIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-103BIOFREEZE COLORLESS (MENTHOL) GEL [RB HEALTH (US) LLC]30Current NDC, Legacy NDC, 7 package rows20241228_939dbbc3-71ec-4990-840e-7c9b8d430562.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
1111683BIOFREEZE 4 % Topical GelPSN939dbbc3-71ec-4990-840e-7c9b8d43056231
415974menthol 4 % Topical GelPSN939dbbc3-71ec-4990-840e-7c9b8d43056231
1111683menthol 0.04 MG/MG Topical Gel [Biofreeze]SBD939dbbc3-71ec-4990-840e-7c9b8d43056231
415974menthol 0.04 MG/MG Topical GelSCD939dbbc3-71ec-4990-840e-7c9b8d43056231
1111683Biofreeze 0.04 MG/MG Topical GelSY939dbbc3-71ec-4990-840e-7c9b8d43056231
1111683Biofreeze 4 % Topical GelSY939dbbc3-71ec-4990-840e-7c9b8d43056231
415974menthol 4 % Topical GelSY939dbbc3-71ec-4990-840e-7c9b8d43056231
1111683BIOFREEZE 4 % Topical GelPSNcc1cba14-da40-4d7d-b522-b5c648798e964
415974menthol 4 % Topical GelPSNcc1cba14-da40-4d7d-b522-b5c648798e964
1111683menthol 0.04 MG/MG Topical Gel [Biofreeze]SBDcc1cba14-da40-4d7d-b522-b5c648798e964
415974menthol 0.04 MG/MG Topical GelSCDcc1cba14-da40-4d7d-b522-b5c648798e964
1111683Biofreeze 0.04 MG/MG Topical GelSYcc1cba14-da40-4d7d-b522-b5c648798e964
1111683Biofreeze 4 % Topical GelSYcc1cba14-da40-4d7d-b522-b5c648798e964
415974menthol 4 % Topical GelSYcc1cba14-da40-4d7d-b522-b5c648798e964

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59316-103-4059316010340946 mL in 1 BOTTLE (59316-103-40) 946 ml2012-01-030000-00-00NoNoCurrent