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 66 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDROCORTISONEHYDROCORTISONEEncube Ethicals, Inc.969cd576-82d3-4662-bbc1-3587a1f6a5642025-11-10WarningsExact identifier
application number: M017
Jelcaine SterileLIDOCAINE HCL JELLY USP, 2%Brookfield Pharmaceuticals, LLC1a39d1de-7aa2-3068-e063-6394a90aed852025-11-10WarningsExact identifier
application number: M017
Hush AnestheticLIDOCAINEHUSH Anestheticc6e86a0f-6f9b-45b7-86ce-0bb1c198061a2025-11-10WarningsExact identifier
application number: M017
Hush AnestheticLIDOCAINEHUSH Anesthetic97ae1993-7268-4b7f-92e2-6004337d56502025-11-10WarningsExact identifier
application number: M017
MENTHOL AND METHYL SALICYLATEELECTRIC MEDICATED BALM ULTRA STRENGTHFEI FAH MEDICAL MANUFACTURING PTE LTD91e6d3b9-25bb-4015-9d96-bd27f93e5ada2025-11-10WarningsExact identifier
application number: M017
E MEI SHAN MEDICATEDCAMPHOR, MENTHOLZhejiang Dingtai Pharmaceutical Co., Ltdbda1e7c1-42df-4126-a512-80f843b07fd02025-11-10WarningsExact identifier
application number: M017
EXTRA STRENGTH HUA TUO PAIN RELIEVINGCAMPHOR AND MENTHOLZhejiang Dingtai Pharmaceutical Co., Ltd9850754b-ac94-4ec6-b75a-8096e5ac94562025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
TONG FENG DING PAIN RELIEFCAMPHOR AND MENTHOLZhejiang Dingtai Pharmaceutical Co., Ltdfe87b864-b3ee-4a4b-8e5a-e1ee6493de0d2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
Solstice Pain RelievingCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INC5ef90782-8201-47d1-b57f-f032d4c9b06a2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
Solstice Pain RelievingCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INC1388ab3a-c26f-427d-898d-0d88411a5fba2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
Solstice Capsaicin Patch HotCAPSAICINMADISON ONE ACME INCf74db6e0-853a-4eb3-a4b5-9da2cd3d95cf2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
Lung Choy Shung Pain Relief LiquidMENTHOL AND CAMPHORMADISON ONE ACME INC4842c6ec-7823-4f6b-afc4-258fce2c23912025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
701 DIEDA ZHENGTONG YAOGAO MEDICATEDCAMPHOR AND MENTHOLMADISON ONE ACME INC115041ff-5046-4ca4-b54b-5652037e74bd2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
EXTRA STRENGTH HUA TUO PAIN RELIEFCAMPHOR AND MENTHOLMADISON ONE ACME INC0f269a41-4b56-4e22-b9cb-17d99bf76a572025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
ZANG HONG HUA PAIN RELIEVINGCAMPHOR, CAPSAICIN, AND METHYL SALICYLATEMADISON ONE ACME INCe0a8811c-07cf-4dee-a0e5-13b8af1b27b62025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
NECK AND LUMBAR PAIN RELIEVING BALMCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INCd06f0650-a5f6-4bc1-a70b-b0fc16968fa92025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
SHU JIN HUO LUO PAIN RELIEVINGCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INCccb6740d-3399-4a2b-ae65-15ca557ba83b2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
GuruNanda Pain ReliefLIDOCAINE HYDROCHLORIDEGuruNanda, LLC.3ab6a133-8dca-e14e-e063-6394a90a85e72025-11-10WarningsExact identifier
application number: M017
HUO LUO PAIN RELIEVINGCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INC65581716-5a2c-4ee8-816d-00caed7b95b42025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
JOSEPHS LION PAIN RELIEVINGCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INC69b88e21-2001-4fb2-b6eb-17f2d6e0ef2e2025-11-10Warnings, Adverse reactionsExact 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