FDA.reportPublic FDA data

Biofreeze Foot Pain Relief Set

Product NDC
59316-002
11-digit product format
593160002
Labeler code
59316
Product ID
59316-002_51b58d16-badb-06b8-e063-6294a90a94ea
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
KIT
Labeler
Reckitt Benckiser LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-12
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 Foot Pain Relief Set
Listing expiration
2027-12-31

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
4a885eef-0364-4655-bccc-7158c76cc5b2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-001-10Biofreeze Foot Pain Relief Set85 g in 1 TUBECREAM85 g100 mg in 1g6
59316-002-10Biofreeze Foot Pain Relief Set1 in 1 KITKIT16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-002BIOFREEZE FOOT PAIN RELIEF SET (MENTHOL) KIT [RB HEALTH (US) LLC]5Current NDC, Legacy NDC, 2 package rows20241228_4a885eef-0364-4655-bccc-7158c76cc5b2.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 9 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REINREUDE BACK PAIN THERAPYCAMPHOR 80MG MENTHOL 24MG BACK PAIN THERAPYJiangxi Yudexi Pharmaceutical Co., LTD4dfc77bb-11dd-e0f0-e063-6294a90a4e9c2026-07-24WarningsExact identifier
application number: M017
DRAVYNOR QUIT SMOKING PatchesNICOTINE18% MENTHOL 0.3% QUIT SMOKING PATCHESWenzhou Yuyuan Pharmaceutical Co., Ltd.5768631f-d517-5b43-e063-6294a90a8f462026-07-24WarningsExact identifier
application number: M017
DERMFREE NUMBINGLIDOCAINE4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4a5b47ce-2bf1-42c7-e063-6294a90af09f2026-07-23WarningsExact identifier
application number: M017
DERMFREE WART CORN REMOVERSALICYLIC ACID 40% WART CORN REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a5c63b3-44de-8736-e063-6394a90ac21a2026-07-23WarningsExact identifier
application number: M017
DERMFREE Anti-itchHYDROCORTISONE1% ANTI-ITCHJiangxi Yudexi Pharmaceutical Co., LTD4a5af4c6-555a-e74c-e063-6394a90aa6ce2026-07-23WarningsExact identifier
application number: M017
DERMFREE HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD4a5d0e79-d620-0147-e063-6294a90a31032026-07-23WarningsExact identifier
application number: M017
MAG 5 PT WARMING FORMULAMENTHOLRENU LABORATORIES, LLCa499ac9b-0e8e-e23f-e053-2a95a90abe9a2026-07-23WarningsExact identifier
application number: M017
Icy Hot Performance Cream Pain ReliefMENTHOL 16%, CAMPHOR 11%Chattem, Inc.73f7a113-ef11-4932-bf4d-4e62863f79412026-07-23WarningsExact identifier
application number: M017
Numbing Pain ReliefLIDOCAINE 4%Walgreen Company2425badb-e196-e9f8-e063-6294a90a7bf42026-07-22WarningsExact identifier
application number: M017
Cooling Pain ReliefMENTHOL 4.5%Walgreen Company24345ccf-c96f-31b0-e063-6294a90a82b52026-07-22WarningsExact identifier
application number: M017
Heat Pain ReliefCAPSAICIN 0.1%Walgreen Company2434f9cf-74aa-17af-e063-6294a90a56d92026-07-22WarningsExact identifier
application number: M017
Pain Relief Patch LidocaineLIDOCAINEHyVee41c26a66-3371-2c2c-e063-6294a90aa38b2026-07-22WarningsExact identifier
application number: M017
CVS Ultra Strength MuscleMENTHOL, CAMPHOR, METHYL SALICYLATECVS Pharmacy48bef8bc-6e39-a328-e063-6394a90ae4502026-07-22WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEAKRON PHARMA INCdaad9a1e-98d2-4ce7-9d97-ac5d81905abb2026-07-22WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pain RelievingMENTHOL, CAMPHORActive and Innovative573c2d85-9e0b-7955-e063-6394a90aff642026-07-22WarningsExact identifier
application number: M017
DOCTOR INK TOPICAL ANTISEPTIC WITH PAIN RELIEFBENZALKONIUM CHLORIDE, LIDOCAINEEnviro Specialty Chemicals Incf7abe66c-dc2d-4ef7-9b11-5b87157fd3022026-07-21WarningsExact identifier
application number: M017
Bclsks NUMBINGMENTHOL 1% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD49e26770-ddf6-7515-e063-6394a90a4ab32026-07-21WarningsExact identifier
application number: M017
Rstrvbr QUIT SMOKINGNICOTINE21MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5e9691-727f-6bcd-e063-6294a90aadfc2026-07-21WarningsExact identifier
application number: M017
Rstrvbr QUIT SMOKINGNICOTINE14MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5eec19-7f9a-d277-e063-6294a90ace952026-07-21WarningsExact identifier
application number: M017
Rstrvbr QUIT SMOKINGNICOTINE7MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5f124e-2dd7-16b8-e063-6294a90a5cdb2026-07-21WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2001133BIOFREEZE 10 % Topical CreamPSN4a885eef-0364-4655-bccc-7158c76cc5b26
253020menthol 10 % Topical CreamPSN4a885eef-0364-4655-bccc-7158c76cc5b26
2001133menthol 100 MG/ML Topical Cream [Biofreeze]SBD4a885eef-0364-4655-bccc-7158c76cc5b26
253020menthol 100 MG/ML Topical CreamSCD4a885eef-0364-4655-bccc-7158c76cc5b26
2001133Biofreeze 10 % Topical CreamSY4a885eef-0364-4655-bccc-7158c76cc5b26
2001133Biofreeze 100 MG/ML Topical CreamSY4a885eef-0364-4655-bccc-7158c76cc5b26
253020menthol 10 % Topical CreamSY4a885eef-0364-4655-bccc-7158c76cc5b26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59316-001-105931600011085 g in 1 TUBE85 gHistorical
59316-002-10593160002101 KIT in 1 KIT (59316-002-10) * 85 g in 1 TUBE (59316-001-10) 1 kit2021-03-120000-00-00NoNoCurrent