FDA.reportPublic FDA data

Biofreeze

Product NDC
59316-992
11-digit product format
593160992
Labeler code
59316
Product ID
59316-992_32859ab1-5873-9a6f-e063-6294a90a86e3
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
2022-03-04
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
.05 g/g
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
Brand name suffix
Menthol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM.05 g/g

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
71a36691-9d9e-479d-bfdc-6f6b192ad2d0Available 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
59316-992-04BiofreezeMenthol4 in 1 CARTONPATCH44
59316-992-04BiofreezeMenthol20 g in 1 PATCHPATCH204
59316-992-07BiofreezeMenthol9 g in 1 PATCHPATCH94
59316-992-07BiofreezeMenthol1 in 1 POUCHPATCH14
59316-992-08BiofreezeMenthol9 g in 1 PATCHPATCH94
59316-992-08BiofreezeMenthol12 in 1 CARTONPATCH124
59316-992-09BiofreezeMenthol5 in 1 CARTONPATCH54
59316-992-09BiofreezeMenthol9 g in 1 PATCHPATCH94
59316-992-32BiofreezeMenthol20 g in 1 PATCHPATCH204
59316-992-32BiofreezeMenthol1 in 1 POUCHPATCH0.05 g in 1g4
59316-992-32BiofreezeMenthol1 in 1 POUCHPATCH14
59316-992-32BiofreezeMenthol20 g in 1 PATCHPATCH20 g0.05 g in 1g4
59316-992-33BiofreezeMenthol1 in 1 POUCHPATCH0.05 g in 1g4
59316-992-33BiofreezeMenthol13 g in 1 PATCHPATCH134
59316-992-33BiofreezeMenthol13 g in 1 PATCHPATCH13 g0.05 g in 1g4
59316-992-33BiofreezeMenthol1 in 1 POUCHPATCH14
59316-992-34BiofreezeMenthol15 in 1 CARTONPATCH154
59316-992-34BiofreezeMenthol9 g in 1 PATCHPATCH94
59316-992-36BiofreezeMenthol12 in 1 CARTONPATCH124
59316-992-36BiofreezeMenthol1 in 1 POUCHPATCH14
59316-992-07Biofreeze Day and Overnight1 in 1 POUCHPATCH0.05 g in 1g3
59316-992-07Biofreeze Day and Overnight9 g in 1 PATCHPATCH54 g in 60.05 g in 1g3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-992-04EA - Each59316-992ce7d8c35-f760-431f-bc8f-185c9b324e2312024-08-12
59316-992-07EA - Each59316-99214757160-2bb7-4dc5-8922-b12629132b8c12022-09-12
59316-992-08EA - Each59316-992fd966c0e-60e6-4700-9ed7-3f0d6e769a6012024-03-12
59316-992-09EA - Each59316-992206abcfe-a47c-4430-aa13-cc3b44a8beef12024-03-12
59316-992-33EA - Each59316-992d0afdc86-c697-4b41-a846-8abf328782bf12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-992BIOFREEZE DAY AND OVERNIGHT (MENTHOL) KIT [RB HEALTH (US) LLC]3Current NDC, Legacy NDC20241228_fb5c8f89-a720-ad32-e053-6294a90a2abe.zip
59316-992BIOFREEZE MENTHOL (MENTHOL, UNSPECIFIED FORM) KIT [RB HEALTH (US) LLC]3Current NDC, Legacy NDC20240927_3f2b1f48-2d78-4985-a046-9f72de5e1a9b.zip
59316-992BIOFREEZE MENTHOL (MENTHOL, UNSPECIFIED FORM) PATCH [RB HEALTH (US) LLC]3Current NDC, Legacy NDC, 16 package rows20240502_71a36691-9d9e-479d-bfdc-6f6b192ad2d0.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 PatchPSN3f2b1f48-2d78-4985-a046-9f72de5e1a9b4
2109627Biofreeze 5 % Medicated PatchPSN71a36691-9d9e-479d-bfdc-6f6b192ad2d04
420222menthol 5 % Medicated PatchPSN3f2b1f48-2d78-4985-a046-9f72de5e1a9b4
420222menthol 5 % Medicated PatchPSN71a36691-9d9e-479d-bfdc-6f6b192ad2d04
2109627menthol 0.05 MG/MG Medicated Patch [Biofreeze]SBD3f2b1f48-2d78-4985-a046-9f72de5e1a9b4
2109627menthol 0.05 MG/MG Medicated Patch [Biofreeze]SBD71a36691-9d9e-479d-bfdc-6f6b192ad2d04
420222menthol 0.05 MG/MG Medicated PatchSCD3f2b1f48-2d78-4985-a046-9f72de5e1a9b4
420222menthol 0.05 MG/MG Medicated PatchSCD71a36691-9d9e-479d-bfdc-6f6b192ad2d04
2109627Biofreeze 0.05 MG/MG Medicated PatchSY3f2b1f48-2d78-4985-a046-9f72de5e1a9b4
2109627Biofreeze 0.05 MG/MG Medicated PatchSY71a36691-9d9e-479d-bfdc-6f6b192ad2d04
420222menthol 5 % Medicated PatchSY3f2b1f48-2d78-4985-a046-9f72de5e1a9b4
420222menthol 5 % Medicated PatchSY71a36691-9d9e-479d-bfdc-6f6b192ad2d04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59316-992-04593160992044 PATCH in 1 CARTON (59316-992-04) / 20 g in 1 PATCH4 patch2024-09-07NoNoCurrent
59316-992-07593160992071 PATCH in 1 POUCH (59316-992-07) / 9 g in 1 PATCH1 patch2022-03-040000-00-00NoNoCurrent
59316-992-085931609920812 PATCH in 1 CARTON (59316-992-08) / 9 g in 1 PATCH12 patch2022-03-040000-00-00NoNoCurrent
59316-992-09593160992095 PATCH in 1 CARTON (59316-992-09) / 9 g in 1 PATCH5 patch2022-03-040000-00-00NoNoCurrent
59316-992-32593160992321 PATCH in 1 POUCH (59316-992-32) / 20 g in 1 PATCH1 patch2022-03-040000-00-00NoNoCurrent
59316-992-33593160992331 PATCH in 1 POUCH (59316-992-33) / 13 g in 1 PATCH1 patch2022-03-040000-00-00NoNoCurrent
59316-992-345931609923415 PATCH in 1 CARTON (59316-992-34) / 9 g in 1 PATCH15 patch2024-10-01NoNoCurrent
59316-992-365931609923612 POUCH in 1 CARTON (59316-992-36) / 1 PATCH in 1 POUCH / 9 g in 1 PATCH12 pouch2022-03-040000-00-00NoNoCurrent