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 130 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TIDL PAIN RELIEF HEAT THERAPY ROLL-ONPAIN RELIEF HEAT THERAPY ROLL-ONShenzhen Sam Technology Co., Ltd.1d0b7b8f-9e5d-00f7-e063-6394a90af87c2024-07-12WarningsExact identifier
application number: M017
TIDL PAIN RELIEF CRYO THERAPY original formula Spray.PAIN RELIEF CRYO THERAPY ORIGINAL FORMULA SPRAYShenzhen Sam Technology Co., Ltd.1d0b94ec-f956-dff2-e063-6294a90aca4a2024-07-12WarningsExact identifier
application number: M017
TIDL PAIN RELIEF CRYO THERAPY MAX Strength Spray.PAIN RELIEF CRYO THERAPY MAX STRENGTH SPRAYShenzhen Sam Technology Co., Ltd.1d0bf4f9-6b02-6cec-e063-6294a90a36c72024-07-12WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINE HCI 2.0%Trifecta Pharmaceuticals USA, LLC.e5e524cd-bb22-715f-e053-2995a90ab5d32024-07-12WarningsExact identifier
application number: M017
Ralli Rapid Pain ReliefMENTHOLTroy Manufacturing, Inc.1d10e3ca-dc93-8e1a-e063-6394a90a47c02024-07-12WarningsExact identifier
application number: M017
TIDL PAIN RELIEF HEAT THERAPY Spray.PAIN RELIEF HEAT THERAPY SPRAYShenzhen Sam Technology Co., Ltd.1d199826-1b27-b6e7-e063-6394a90a69ad2024-07-12WarningsExact identifier
application number: M017
Tidl Pain Relief Morning Therapy Spray.PAIN RELIEF MORNING THERAPY SPRAYShenzhen Sam Technology Co., Ltd.1d19d070-3818-73de-e063-6394a90a89582024-07-12WarningsExact identifier
application number: M017
Hydrocortisone with aloeHYDROCORTISONE WITH ALOE ANTI ITCHNeilMed Pharmaceuticals Inc.032b9f58-5f64-04dd-e063-6294a90a6bb92024-07-10WarningsExact identifier
application number: M017
Octagon Pain ReliefMENTHOL, UNSPECIFIED FORMNATURAL ESSENTIALS, INC.9926f733-1506-4224-9d70-b1813cd81ec32024-07-08WarningsExact identifier
application number: M017
LidoReal PatchLIDOCAINE AND MENTHOLFORREAL PHARMACEUTICALS LLC19f1c037-b4b8-47b0-b0f9-036691c1d3072024-07-05WarningsExact identifier
application number: M017
Lip Medex Lip BalmPETROLATUM, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND PHENOLBlistex Inc.988f97e8-a59f-4bc0-9d71-60607364a6862024-07-01WarningsExact identifier
application number: M017
Maybelline New York BABY LIPS DR RESCURE MENTHOL EXTERNAL ANALGESIC MEDICATED BALMMENTHOLL'Oreal USA Products Incd580982f-dda6-4b03-bf84-342b9f2c6d932024-06-29WarningsExact identifier
application number: M017
Lip Medex CherryPETROLATUM, CAMPHOR (SYNTHETIC), AND MENTHOL, UNSPECIFIED FORMBlistex Inc.fa8b3fb1-08e5-4876-9c4a-6aa8c9f23af82024-06-28WarningsExact identifier
application number: M017
10% Methyl Salicylate Pain Relief Patch10% METHYL SALICYLATEAkron Coating & Adhesives1be1f1ce-3238-a8ed-e063-6294a90a5aed2024-06-27Exact identifier
application number: M017
Genuine First Aid Alcohol Cleansing PadBENZOCAINE, ALCOHOLGFA Production (Xiamen) Co., Ltd.c39c4d80-9718-459f-8ae4-ada043bba5b72024-06-26WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll OnMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA1bd5cf69-9a08-5e2e-e063-6394a90a03cd2024-06-26WarningsExact identifier
application number: M017
Solarcaine Burn Pain Relief 4ozSOLARCAINE BURN PAIN RELIEF 4OZWellSpring Pharmaceutical Corporation2c0389db-ceb2-422b-9575-bdb8fe649a1e2024-06-26WarningsExact identifier
application number: M017
astoneaHYDROCORTISONEASTONEA LABS PRIVATE LIMITEDde09e859-c5fd-0cc5-e053-2a95a90a147e2024-06-25WarningsExact identifier
application number: M017
HealthWise Pain Relief Lidocaine PatchLIDOCAINE 4%Veridian Healthcare0190196d-5f78-042b-e063-6294a90a37142024-06-25WarningsExact identifier
application number: M017
Eagle Brand Medicated OilMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA1bc1bf83-91ee-ec9d-e063-6394a90a3daf2024-06-25WarningsExact 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