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 85 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alocane PlusLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products, Inc.24538037-1d74-48a0-b909-98ecc57651fe2025-07-17WarningsExact identifier
application number: M017
Hydrocortisone anti-itch plusHYDROCORTISONEWal-Mart Stores, Inc.a0c6e180-b385-4a9b-a9cf-84a551f533d02025-07-16WarningsExact identifier
application number: M017
OTC Rescue Lidocaine Pain Relief PatchLIDOCAINEVeridian Healthcare0e742fc6-5f76-d202-e063-6394a90acf312025-07-16WarningsExact identifier
application number: M017
Itch ReliefHYDROCORTISONESTRATEGIC SOURCING SERVICES LLCae4b7cd6-8b5d-4d25-86f9-72260638bb942025-07-16WarningsExact identifier
application number: M017
Freds Hydrocortisone Plus 12 MoisturizersHYDROCORTISONEFRED'S, INC.7502eebe-11c5-4e9e-b427-b87180a843492025-07-16WarningsExact identifier
application number: M017
PROINNATE Numbing CreamMENTHOLGuangzhou Haishi Biological Technology Co., Ltd.39688b2b-c1fe-cd86-e063-6394a90a53452025-07-16WarningsExact identifier
application number: M017
Methyl SalicylateMETHYL SALICYLATEViolaCare, Inc.8f0ba6e7-8aa4-443e-99ae-a255085ddfec2025-07-15WarningsExact identifier
application number: M017
TopCare Hydrocortisone Intensive Healing FormulaHYDROCORTISONETopco Associates LLC7daafc44-e2a4-4f1b-bfca-3309a8e9a9202025-07-15WarningsExact identifier
application number: M017
Hydrocortisone Plus 12 MoisturizersHYDROCORTISONETARGET Corporation72c3889c-b743-4728-a315-6e4063e002002025-07-15WarningsExact identifier
application number: M017
Shopko Hydrocortisone Maximum StrengthHYDROCORTISONEShopko Stores Operating Co., LLC0431a6af-4c9a-4bbd-a535-cba31a5e53cc2025-07-15WarningsExact identifier
application number: M017
Freds Hydrocortisone with AloeHYDROCORTISONEFRED'S, INC.076503bf-8238-4739-bb1c-c385e72f8a962025-07-15WarningsExact identifier
application number: M017
Shopko HydrocortisoneHYDROCORTISONEShopko Stores Operating Co., LLC92bcbde3-401a-4301-854e-c352852317d62025-07-15WarningsExact identifier
application number: M017
TopCare HydrocortisoneHYDROCORTISONETopco Associates LLCbd3585fa-3b48-49b7-8ad1-749bf1e31ed52025-07-15WarningsExact identifier
application number: M017
Methyl Salicylate 25% Pain RelievingMETHYL SALICYLATEPuretek Corporation376797ff-cf13-a3c6-e063-6394a90a9de12025-07-15WarningsExact identifier
application number: M017
TIGER BALM PAIN RELIEVINGCAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUMHaw Par Healthcare Ltd.440e97bc-bd97-4733-9955-643b18e7fb182025-07-15WarningsExact identifier
application number: M017
Tiger Balm Pain Relieving Hydrogel LargeCAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUMHaw Par Healthcare Ltd.064d04ca-184d-492b-867c-beaa165ab3e02025-07-14WarningsExact identifier
application number: M017
Methyl Salicylate 25% CreamMETHYL SALICYLATEMedcore LLC143f76bf-2de4-466a-8a6b-d6ab6314a2c32025-07-14WarningsExact identifier
application number: M017
BLUESPRING Doctors Pain Formula Pain ReliefMENTHOLACA MANAGEMENT LLC98f3f719-792f-4a93-95b1-90072e0f8bf42025-07-14WarningsExact identifier
application number: M017
Shopko Anti-ItchDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEShopko Stores Operating Co., LLC130119eb-b87e-4a07-8d2a-317369bfa5412025-07-14WarningsExact identifier
application number: M017
Equate Hydrocortisone Intensive Healing FormulaHYDROCORTISONEWal-Mart Stores Inc.635b49c4-54d2-4b6d-bee8-851fc2c7ca9c2025-07-14WarningsExact 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