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 71 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Care Cold and HotMENTHOL, AND METHYL SALICYLATESafeway Inc.ab201023-e3dc-52ec-e053-2995a90a1f182025-10-24WarningsExact identifier
application number: M017
HealthWise Medicated Cold Hot 5% PatchMENTHOLVeridian Healthcare15aef56f-cd25-05ac-e063-6394a90a07bb2025-10-23WarningsExact identifier
application number: M017
AlivioLIDOCAINEAmerise Pharmaceuticals LLCeb3a98f1-c875-4f08-8b4b-44e22626b6092025-10-23WarningsExact identifier
application number: M017
Pain Relieveing Gel-PatchLIDOCAINEBullet point LLC41d507c4-ad37-2686-e063-6394a90aae5b2025-10-23WarningsExact identifier
application number: M017
ActivICEMENTHOLMedline Industries, LP98fa9a34-0e1e-0997-e053-2a95a90ac77d2025-10-23WarningsExact identifier
application number: M017
Coralite Pain Relief HotMENTHOL AND CAPSAICINUnited Exchange Corporation78eb133d-01bb-6466-e053-2991aa0accc02025-10-23WarningsExact identifier
application number: M017
AmericaineBENZOCAINEInsight Pharmaceuticals LLC4fd14452-0285-40c4-b835-36935c2056b22025-10-23WarningsExact identifier
application number: M017
zourunan PAIN RELIEFPAIN RELIEFGuchutang Biotechnology (Longyan) Co., Ltd41bc1c0c-63d5-0d41-e063-6394a90a341b2025-10-22WarningsExact identifier
application number: M017
zourunan PAIN RELIEFPAIN RELIEFGuchutang Biotechnology (Longyan) Co., Ltd41bd0769-6ba0-d0d5-e063-6294a90af7c92025-10-22WarningsExact identifier
application number: M017
Coralite Extra Strength Pain Relief Sleeve KneeMENTHOLUnited Exchange Corp.aa5873bd-af64-41cc-8f16-7714c56bca962025-10-22WarningsExact identifier
application number: M017
Family Care Muscle RubCAMPHOR, MENTHOL, AND METHYL SALICYLATEUnited Exchange Corp.63006bb5-76e8-eb64-e053-2991aa0a95ad2025-10-22WarningsExact identifier
application number: M017
Winco Cold and Hot Medicated Patch LargeMENTHOLWINCO FOODS, LLCaf0d86c4-f74e-2dbe-e053-2a95a90a74c12025-10-22WarningsExact identifier
application number: M017
Coralite Cold and HotMENTHOLUnited Exchange Corp.064a6149-a0e2-8a73-e063-6394a90a79532025-10-22WarningsExact identifier
application number: M017
Topical AnalgesicMENTHOLYoungevity International Inc.b4693947-f5b3-6fd3-e053-2995a90ab5812025-10-22WarningsExact identifier
application number: M017
PAIN RELIEVINGLIDOCAINEMedhome Pharma Inc41cb1135-84e0-0c9a-e063-6294a90ada962025-10-22WarningsExact identifier
application number: M017
KINKANAMMONIA, CAMPHOR (NATURAL), MENTHOLKINKANDO CO., LTD .f2c0f3e1-792b-4798-bf6d-acd1bbefa2612025-10-21WarningsExact identifier
application number: M017
Coralite Muscle and Joint Pain ReliefCAPSACINUnited Exchange Corp.ba9a3d72-db7a-4dd0-9220-f43c9ed871142025-10-21WarningsExact identifier
application number: M017
Coralite Extra Strength Pain Relief Sleeve WristMENTHOLUnited Exchange Corp.ae314478-b8ab-4e90-bd0a-7a882d5c1b2e2025-10-21WarningsExact identifier
application number: M017
Coralite Cold and HotMENTHOLUnited Exchange Corp.85bd7658-e951-7daf-e053-2a91aa0a9f542025-10-21WarningsExact identifier
application number: M017
Family Care Maximum Strength Medicated Anti ItchMENTHOLUnited Exchange Corp.430b5753-3087-4cb1-bf54-0eedc3f4b1d52025-10-21WarningsExact 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