FDA.reportPublic FDA data

Biofreeze

Product NDC
59316-101
Requested package NDC
59316-101-10
11-digit product format
593160101
Labeler code
59316
Product ID
59316-101_51b434c9-228b-2c05-e063-6394a90a1e94
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
2016-08-25
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
35 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 FORM35 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
808955Internal RxNorm lookup
1043451Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
684faf63-5e44-4471-8384-e8fa7c0d842aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-101-10Biofreeze5 mL in 1 PACKETGEL543
59316-101-11Biofreeze30 mL in 1 BOTTLEGEL3043
59316-101-12Biofreeze59 mL in 1 TUBEGEL5943
59316-101-13Biofreeze59 mL in 1 BOTTLE, WITH APPLICATORGEL5943
59316-101-15Biofreeze89 mL in 1 BOTTLE, WITH APPLICATORGEL8943
59316-101-19Biofreeze3 mL in 1 PACKETGEL343
59316-101-20Biofreeze118 mL in 1 TUBEGEL11843
59316-101-21Biofreeze81 mL in 1 TUBEGEL8143
59316-101-25Biofreeze118 mL in 1 TUBE, WITH APPLICATORGEL11843
59316-101-30Biofreeze473 mL in 1 BOTTLE, PUMPGEL47343
59316-101-40Biofreeze946 mL in 1 BOTTLE, PUMPGEL94643
59316-101-50Biofreeze3785 mL in 1 BOTTLE, PUMPGEL378543

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MentholACTIVE INGREDIENTL7T10EIP3ABIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC.]32
MentholACTIVE MOIETYL7T10EIP3ABIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC.]32
CAMPHOR (NATURAL)INACTIVE INGREDIENTN20HL7Q941BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC.]32
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC.]32
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MBIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC.]32
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC.]32
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC.]32
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC.]32
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC.]32
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC.]32
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKBIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC.]32
WATERINACTIVE INGREDIENT059QF0KO0RBIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC.]32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-101BIOFREEZE (MENTHOL) GEL [RB HEALTH (US) LLC]42Current NDC, Legacy NDC, 12 package rows20241228_684faf63-5e44-4471-8384-e8fa7c0d842a.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
1043451BIOFREEZE 3.5 % Topical GelPSN684faf63-5e44-4471-8384-e8fa7c0d842a43
808955menthol 3.5 % Topical GelPSN684faf63-5e44-4471-8384-e8fa7c0d842a43
1043451menthol 0.035 MG/MG Topical Gel [Biofreeze]SBD684faf63-5e44-4471-8384-e8fa7c0d842a43
808955menthol 0.035 MG/MG Topical GelSCD684faf63-5e44-4471-8384-e8fa7c0d842a43
1043451Biofreeze 0.035 MG/MG Topical GelSY684faf63-5e44-4471-8384-e8fa7c0d842a43
1043451Biofreeze 3.5 % Topical GelSY684faf63-5e44-4471-8384-e8fa7c0d842a43
808955menthol 3.5 % Topical GelSY684faf63-5e44-4471-8384-e8fa7c0d842a43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59316-101-10593160101105 mL in 1 PACKET (59316-101-10) 5 ml2016-08-250000-00-00NoNoCurrent