FDA.reportPublic FDA data

Biofreeze Flexible Relief Strip

Product NDC
59316-004
11-digit product format
593160004
Labeler code
59316
Product ID
59316-004_51b597cc-806d-e160-e063-6394a90ac1be
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
PATCH
Route
TOPICAL
Labeler
Reckitt Benckiser LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-31
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
56 mg/g
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 Flexible Relief Strip
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM56 mg/g

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2566836Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6ec26bae-e395-49aa-969e-8c653d6f0b27Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-004-01Biofreeze Flexible Relief Strip6 g in 1 PATCHPATCH65
59316-004-01Biofreeze Flexible Relief Strip1 in 1 POUCHPATCH15
59316-004-04Biofreeze Flexible Relief Strip4 in 1 CARTONPATCH45
59316-004-04Biofreeze Flexible Relief Strip6 g in 1 PATCHPATCH65

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-004BIOFREEZE FLEXIBLE RELIEF STRIP (MENTHOL) PATCH [RB HEALTH (US) LLC]4Current NDC, Legacy NDC, 4 package rows20241228_6ec26bae-e395-49aa-969e-8c653d6f0b27.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 55 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ElixirLidoFastLIDOCAINE 5% CREAMELIXIR HEALTHCARE USA, LLC.45de5a3d-06c2-aa02-e063-6294a90a63d32025-12-13WarningsExact identifier
application number: M017
MEDI FIRST PLUSHYDROCORTISONE ACETATEOrazen Inc5781124a-60f4-4a64-80b7-ce5f28d495b52025-12-12WarningsExact identifier
application number: M017
MEDI-FIRSTHYDROCORTISONE ACETATEOrazen Incaeffd85c-58a7-4d64-bf94-977b6fbbe7132025-12-12WarningsExact identifier
application number: M017
Joint and Muscle ReliefMENTHOLSmart Cookie Solutions Inc.45c24d56-4dc9-2884-e063-6294a90a52cc2025-12-12WarningsExact identifier
application number: M017
PopstarDELAY SPRAYPineapple Brands LLC293b2da9-1261-0358-e063-6394a90aa08c2025-12-12WarningsExact identifier
application number: M017
Careland Pain Relief PlusCAMPHOR, MENTHOL, METHYL SALICYLATEPlanet (Anhui) Pharmaceutical Co., Ltd.d9e63ddd-d003-45fa-b156-7f4452c28cbd2025-12-12WarningsExact identifier
application number: M017
Glucosamine Cream EXTRA STRENGTHHISTAMINE DIHYDROCHLORIDEIDEAZ, LLCf4d414b7-89e7-ad65-e053-2a95a90a25d42025-12-12WarningsExact identifier
application number: M017
ARTHRITISMENTHOLSmith Amish, LLC20c36972-b695-1241-e063-6394a90adf632025-12-12WarningsExact identifier
application number: M017
FOOTMENTHOLSmith Amish, LLC20c48537-f55f-c10f-e063-6394a90a4cca2025-12-12WarningsExact identifier
application number: M017
Joint EaseMENTHOLSmith Amish, LLC20c4a0f8-bdc6-d89a-e063-6294a90aa8d82025-12-12WarningsExact identifier
application number: M017
Toast Screamin HotCAPSAICINIDEAZ, LLC331207e6-b8ac-b169-e063-6394a90ac1692025-12-12WarningsExact identifier
application number: M017
Pain Relief Gel-PatchLIDOCAINEKORVIA GLOBAL Inc.45ccfcae-a307-1c5f-e063-6294a90acf892025-12-12WarningsExact identifier
application number: M017
Lidospot patchLIDOCAINE AND MENTHOLFabrication Enterprises Inc3a6e94c4-1ca6-e77a-e063-6394a90a4bfc2025-12-12WarningsExact identifier
application number: M017
LETEBEE LIGHT neuropathy pain relief cream for feetMENTHOLGuangdong Aimu Biological Technology Co., Ltd45a99afc-15ec-76c2-e063-6294a90a22202025-12-11WarningsExact identifier
application number: M017
CintheraLIDOCAINEStrand Health Group2746e5b2-be2d-f2d2-e063-6394a90a36902025-12-11WarningsExact identifier
application number: M017
Equate Cool and Heat Pain Relieving LiquidCOOL AND HEAT PAIN RELIEFWalmart, Inc.ad156685-3bd5-6837-e053-2995a90ac7882025-12-11WarningsExact identifier
application number: M017
HUMCO Camphor SpiritCAMPHOR 10%Humco Holding Group, Inc.9a0ef0a3-3c79-41b2-8193-424a3ef9886f2025-12-11WarningsExact identifier
application number: M017
T-Relief Lidocaine HCL 4%LIDOCAINE HCL 4%Medinatura New Mexico Inc.3c19aff8-fb18-78d0-e063-6294a90a94812025-12-11WarningsExact identifier
application number: M017
JointivaTROLAMINE SALICYLATE 10%Rising Pharma Holdings, Inc.3ee33cbf-7c0f-4982-b0b6-eeeb0202803b2025-12-11WarningsExact identifier
application number: M017
LMX4LIDOCAINEFerndale Laboratories, Inc.f0e7c92f-8b0b-4045-b659-af9f6e81260f2025-12-10WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2566836menthol 5.6 % Medicated PatchPSN6ec26bae-e395-49aa-969e-8c653d6f0b275
2566836menthol 0.056 MG/MG Medicated PatchSCD6ec26bae-e395-49aa-969e-8c653d6f0b275
2566836menthol 5.6 % Medicated PatchSY6ec26bae-e395-49aa-969e-8c653d6f0b275

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59316-004-01593160004011 PATCH in 1 POUCH (59316-004-01) / 6 g in 1 PATCH1 patch2021-03-310000-00-00NoNoCurrent
59316-004-04593160004044 PATCH in 1 CARTON (59316-004-04) / 6 g in 1 PATCH4 patch2021-03-310000-00-00NoNoCurrent