FDA.reportPublic FDA data

Biofreeze Overnight Relief

Product NDC
59316-005
11-digit product format
593160005
Labeler code
59316
Product ID
59316-005_51e06e35-8e98-7ff9-e063-6294a90a2dff
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol, Unspecified Form
Dosage form
PATCH
Route
TOPICAL
Labeler
Reckitt Benckiser LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-02-01
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
.3 g/6g
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 Overnight Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM.3 g/6g

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
420222Internal RxNorm lookup
2109627Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
07be6e88-1850-4d6a-946d-f03830b8c4a2Available 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
59316-005-03Biofreeze Overnight Relief6 g in 1 PATCHPATCH64
59316-005-04Biofreeze Overnight Relief4 in 1 CARTONPATCH44
59316-005-04Biofreeze Overnight Relief6 g in 1 PATCHPATCH64
59316-005-03Biofreeze Day and Overnight6 g in 1 PATCHPATCH18 g in 30.3 g in 6g3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-005-03EA - Each59316-0057e7f9f50-b410-4c12-aa38-8d2f35766da812024-03-12
59316-005-04EA - Each59316-005386d98f5-94c6-4567-a126-8146bffdd32512024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-005BIOFREEZE DAY AND OVERNIGHT (MENTHOL) KIT [RB HEALTH (US) LLC]3Current NDC, Legacy NDC20241228_fb5c8f89-a720-ad32-e053-6294a90a2abe.zip
59316-005BIOFREEZE OVERNIGHT RELIEF (MENTHOL, UNSPECIFIED FORM) PATCH [RB HEALTH (US) LLC]3Current NDC, Legacy NDC, 3 package rows20231214_07be6e88-1850-4d6a-946d-f03830b8c4a2.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 53 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZIMS MAX FREEZELIDOCAINE HYDROCHLORIDE AND MENTHOL,KOBAYASHI Healthcare International, Inc.e364ff83-4aaf-4897-a7da-06581bc321f22025-12-18WarningsExact identifier
application number: M017
Tiger Balm White Regular StrengthCAMPHOR (SYNTHETIC) AND MENTHOLHaw Par Healthcare Ltd.f406161e-a9c4-47d1-8b21-93b1b79380632025-12-17WarningsExact identifier
application number: M017
ResinolPETROLATUM AND RESORCINOLResiCal, Inc.03f57a4a-f94b-4ba6-b709-41cfb6e162612025-12-17WarningsExact identifier
application number: M017
HealthWise Maximum Pain ReliefLIDOCAINEVeridian Healthcareafc3c16d-0076-44b2-ae7e-5f36d4d8088e2025-12-17WarningsExact identifier
application number: M017
HealthWise Max Lidocaine plus MentholLIDOCAINE, MENTHOLVeridian Healthcaref39a27da-6799-4fc6-97ca-101eac4a93602025-12-17WarningsExact identifier
application number: M017
HealthWise Original MentholMENTHOLVeridian Healthcaree4bfb6b0-545e-4fbc-8538-4f41a6be10252025-12-17WarningsExact identifier
application number: M017
Welly Polka First Aid KitHYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEDongguan Shenglian Tins Products Co., Ltd.d7c4314c-c4c6-4adf-b384-3ac7a71083192025-12-17WarningsExact identifier
application number: M017
Frankincense and Myrrh Arthritis Pain TherapyMENTHOLWise Consumer Products2410a199-f4a3-da6c-e063-6394a90aaace2025-12-17WarningsExact identifier
application number: M017
LidocaineLIDOCAINE, MENTHOLVive Health LLC462d3b24-643e-91da-e063-6394a90a0e1d2025-12-17WarningsExact identifier
application number: M017
TheragesicMETHYL SALICYLATEMission Pharmacal Companydb6c0c77-0a20-d574-a98f-e6c9998b941f2025-12-17WarningsExact identifier
application number: M017
Teevodar Pain RelievingMENTHOLSod-e Biotech Ltd205b0fef-4f00-db2e-e063-6294a90a93b82025-12-17WarningsExact identifier
application number: M017
Frankincense and Myrrh Arthritis Pain ReliefMENTHOLWISE CONSUMER PRODUCTS CO.116045df-891b-f370-e063-6294a90abe422025-12-17WarningsExact identifier
application number: M017
Frankincense and Myrrh Intensive Foot TherapyMENTHOLWise Consumer Products23e56c6b-0f2b-721f-e063-6394a90a1ed02025-12-17WarningsExact identifier
application number: M017
Tiger Balm Ultra StrengthCAMPHOR (SYNTHETIC) AND MENTHOLHaw Par Healthcare Ltd.f0561804-e0f7-495d-9768-9b86a208c51e2025-12-17WarningsExact identifier
application number: M017
Kwan LoongMETHYL SALICYLATE AND MENTHOLHaw Par Healthcare Ltd.54bcb26e-786a-403e-9330-11ae9e3c013a2025-12-17WarningsExact identifier
application number: M017
Magsoothium Body Cooling FormulaMENTHOLUbu/Elements, Inc.f7fb6ac9-a920-a440-e053-6394a90aaa352025-12-16WarningsExact identifier
application number: M017
Magsoothium CBD Body LavenderMENTHOLUbu/Elements, Inc.f9b87fbe-b889-67a1-e053-6394a90acbcd2025-12-16WarningsExact identifier
application number: M017
Aquaphor Itch ReliefHYDROCORTISONEBeiersdorf Incb1d0333f-ba60-35d8-e053-2995a90af9322025-12-16WarningsExact identifier
application number: M017
Magsoothium CBD BodyMENTHOLUbu/Elements, Inc.00b2ef34-42d7-523c-e063-6294a90a753d2025-12-16WarningsExact identifier
application number: M017
GENTLECARE HAND AND SKIN SANITIZERBENZALKONIUM CHLORIDEPARAGON SOLUTIONS US, INC.16650277-fa62-485e-9a82-7763d2b501682025-12-16WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2109627Biofreeze 5 % Medicated PatchPSN07be6e88-1850-4d6a-946d-f03830b8c4a24
420222menthol 5 % Medicated PatchPSN07be6e88-1850-4d6a-946d-f03830b8c4a24
2109627menthol 0.05 MG/MG Medicated Patch [Biofreeze]SBD07be6e88-1850-4d6a-946d-f03830b8c4a24
420222menthol 0.05 MG/MG Medicated PatchSCD07be6e88-1850-4d6a-946d-f03830b8c4a24
2109627Biofreeze 0.05 MG/MG Medicated PatchSY07be6e88-1850-4d6a-946d-f03830b8c4a24
420222menthol 5 % Medicated PatchSY07be6e88-1850-4d6a-946d-f03830b8c4a24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59316-005-03593160005036 g in 1 PATCH (59316-005-03) 6 g2022-02-010000-00-00NoNoCurrent
59316-005-04593160005044 PATCH in 1 CARTON (59316-005-04) / 6 g in 1 PATCH4 patch2022-02-010000-00-00NoNoCurrent