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 40 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Itch Relief GelDIPHENHYDRAMINE HCLWalgreens487060a7-dff3-4840-b967-ca919f8d0a292026-01-15WarningsExact identifier
application number: M017
Walgreen Itch Relief GelDIPHENHYDRAMINE HYDROCHLORIDEWalgreens5aca3297-406f-4165-9895-c58ccffb374f2026-01-15WarningsExact identifier
application number: M017
Pain Relieving PatchLIDOCAINEFlexiGo Inc.4868af2a-c4be-9c68-e063-6394a90a565b2026-01-15WarningsExact identifier
application number: M017
Helocaine Cold Sore Fever Blister TreatmentTETRACAINE, MINERALPagari Life Science Corp.1b2eae09-5de0-9219-e063-6294a90af0462026-01-15WarningsExact identifier
application number: M017
Careland Lidocaine 4 Pain Relieving Gel-PatchesLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.a6ca8382-7ce5-4df9-912e-8a0ac04231162026-01-15WarningsExact identifier
application number: M017
Neuropathy CreamMENTHOL CREAMOwell Naturals Brand, LLC48739205-627b-41d0-e063-6394a90a34622026-01-15WarningsExact identifier
application number: M017
BLT 1BENZOCAINECENTURA PHARMACEUTICALS INC3eea2171-850b-4045-e054-00144ff8d46c2026-01-15WarningsExact identifier
application number: M017
Icy Hot Lidocaine DryLIDOCAINE, MENTHOLChattem, Inc.d500a74e-ab93-4919-8665-a89e9d4cad282026-01-15WarningsExact identifier
application number: M017
Cortizone 10 Bug Bite Relief1% HYDROCORTISONEChattem, Inc.b21b6c04-8246-4567-98cf-64e8c588e79c2026-01-15WarningsExact identifier
application number: M017
Gold Bond Intensive Relief Anti-ItchPRAMOXINE HYDROCHLORIDE, MENTHOLChattem, Inc.e5a3f8d4-b3d8-4b88-b9a9-833406d3e6f82026-01-14WarningsExact identifier
application number: M017
Cortizone-10 Soothing Aloe CremeHYDROCORTISONEChattem, Inc.1a841bf0-9d7b-4566-b442-aa9bcc8278462026-01-14WarningsExact identifier
application number: M017
Cortisone 10 Sensitive Skin CremeHYDROCORTISONEChattem, Inc.b139917c-00bb-4cb3-995d-a6d2f2c295c62026-01-14WarningsExact identifier
application number: M017
Cortizone 10 for PsoriasisHYDROCORTIZONEChattem, Inc.fad9eedb-95e1-4e1a-91e5-0bfd077e0cf52026-01-14WarningsExact identifier
application number: M017
Pain Relief Roll OnTOPICAL ANALGESICEagle Labs Inc2380a400-062a-4a8d-a594-a2e0972190442026-01-14WarningsExact identifier
application number: M017
LidocaineLIDOCAINE 4%AvKARE70aace2f-47b4-e961-e053-2991aa0a63672026-01-14WarningsExact identifier
application number: M017
JUST CBD - ULTRA RELIEFMENTHOL, CAMPHORJust Brands LLC485f355a-4458-67b6-e063-6394a90ab2a02026-01-14WarningsExact identifier
application number: M017
Relief Pain Relieving CreamMENTHOLCorganics, LP85814fff-35f8-447f-b669-87eaf55e98592026-01-14WarningsExact identifier
application number: M017
Mentholatum Soothing Vapor Rub CherryCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Company486269c9-af3a-7856-e063-6294a90a378c2026-01-14WarningsExact identifier
application number: M017
Mentholatum Vapor MaxCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Company4863606f-f7c8-b4a4-e063-6294a90a11382026-01-14WarningsExact identifier
application number: M017
Hydrocortisone Cream Intensive HealingHYDROCORTISONE CREAMWalgreens8a3f486c-1353-466d-9ea7-c14559b53bf32026-01-14WarningsExact 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