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 21 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
New TerocinMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLASCLEMED USA INC.68dc0231-3364-448b-bde9-f19fa122c7652026-05-05WarningsExact identifier
application number: M017
Lidocaine 4% PatchLIDOCAINE 4%SOLA Pharmaceuticalsc31957dd-edea-ce98-e053-2a95a90a9c2d2026-05-05WarningsExact identifier
application number: M017
Biofreeze Triple Target GelCAMPHOR, CAPSAICIN, MENTHOLReckitt Benckiser LLC511852c8-7428-3234-e063-6394a90a5bc22026-05-05WarningsExact identifier
application number: M017
5Kind DMSO Pain RelievingCAMPHOR (SYNTHETIC)5Kind Trading LTD62b55114-47f4-473a-8406-78238c3c1fa22026-05-04WarningsExact identifier
application number: M017
Zinc Oxide with Menthol and White PetrolatumMENTHOL, ZINC OXIDE, WHITE PETROLATUMAldermed Inc.f993fc0a-bd80-4345-a948-65ac03f910e22026-05-04WarningsExact identifier
application number: M017
EVERLIT CARE PRODUCTS BURN RELIEFLIDOCAINE HYDROCHLORIDEEVERLIT GLOBAL INC.d7ec5720-4d1f-4943-ae36-c7d6acbae7d72026-05-04WarningsExact identifier
application number: M017
EVERLIT CARE PRODUCTS BURN RELIEFLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.5371dae4-ea63-46cc-ac26-5418f359c63e2026-05-04WarningsExact identifier
application number: M017
EVERLIT CARE BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.a2cf1726-3dc9-4624-b898-ac91fb4cbdb22026-05-04WarningsExact identifier
application number: M017
FIRSTAR BURNLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.186343c5-2e71-49c4-8d64-5fb3131239fa2026-05-04WarningsExact identifier
application number: M017
Feminine Anti Itch CreamBENZOCAINE,RESORCINOLTRIFECTA PHARMACEUTICALS USA LLC50c3acbf-b873-908a-e063-6294a90a66b72026-05-01WarningsExact identifier
application number: M017
24 7 Relief and Recovery Pain RelievingMENTHOL, UNSPECIFIED FORMTriplicare Inc53ca807b-3ec2-4b5e-aa5a-6dcb756bb4232026-04-30WarningsExact identifier
application number: M017
FIRST AID BURNLIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDE4 Visions LLC50b1351d-72dd-e0c9-e063-6294a90ac7432026-04-30WarningsExact identifier
application number: M017
TheraCare Flexible Pain RelievingLIDOCAINEVeridian Healthcare4f108002-2cae-0671-e063-6294a90ab6cf2026-04-30WarningsExact identifier
application number: M017
Pain Relief Gel Roll OnMENTHOLTrifecta Pharmaceuticals USA50b1a420-d5cd-6d61-e063-6294a90a04512026-04-30WarningsExact identifier
application number: M017
Dr. NumbLIDOCAINE AND BENZETHONIUM CHLORIDE CREAMShinpharma Incd8cdccdb-775b-4970-a6ea-50b62df221d62026-04-30WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEPadagis Israel Pharmaceuticals Ltd2dc7f76f-f9ad-46ba-8b41-952e1c15f0522026-04-29WarningsExact identifier
application number: M017
anti itchHYDROCORTISONEHyVee Ince1db3641-2e83-4fec-8394-98d0d876ce0d2026-04-29WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll OnMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA50805eee-33b3-86bd-e063-6294a90a77d82026-04-28WarningsExact identifier
application number: M017
FixMySkin Healing Balm Vanilla FlavorHYDROCORTISONELovely Skin, Inc.52f7a561-a0b5-4562-a588-d74fd874b83a2026-04-28WarningsExact identifier
application number: M017
Blue Star MedicatedCAMPHORFocus Consumer Healthcare, LLC56df008e-a23b-4870-e054-00144ff8d46c2026-04-27WarningsExact 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