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 133 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HealthWise 3x Medicated Pain Relief PatchCAMPHOR,MENTHOL, METHYL SALICYLATEVeridian Healthcare164d4d62-00c0-e06d-e063-6294a90abd732024-04-17WarningsExact identifier
application number: M017
TIGER Balm PAIN RELIEVING HYDROGELCAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUMHaw Par Healthcare Ltd.ca601b02-e9be-4d8d-a384-c62553302ceb2024-04-16WarningsExact identifier
application number: M017
Lidocaine Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHHenan Enokon Medical Instrument Co., Ltd.1592a40a-a647-34bd-e063-6394a90a0a102024-04-08WarningsExact identifier
application number: M017
MenticamCAMPHOR, MENTHOL, METHYL SALICYLATEPureTek Corporation081837a8-9669-be1f-e063-6394a90a9d202024-04-05WarningsExact identifier
application number: M017
Pain Relieving LinimentCAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORMJ.R. Watkins, LLC.97a0c839-0927-4e54-aee2-ded2016ac4a02024-04-02WarningsExact identifier
application number: M017
HealthWise Capsaicin Heat PatchCAPSAICINVeridian Healthcare150c1f09-8aa7-67ea-e063-6294a90a950a2024-04-01WarningsExact identifier
application number: M017
HealthWise Roll-On Lidocaine Pain Relief Liquid Lavender ScentLIDOCAINE HCIVeridian Healthcare150d3e54-5c8d-19ef-e063-6394a90a70c22024-04-01WarningsExact identifier
application number: M017
Meijer Pain Relief CreamLIDOCAINEMeijer Distribution07ecee44-387a-cdce-e063-6294a90ab9c92024-03-27WarningsExact identifier
application number: M017
Hydrocortisone CreamHYDROCORTISONETrifecta Pharmaceuticals USA141aa2a7-8789-1127-e063-6294a90a2d232024-03-20WarningsExact identifier
application number: M017
Pain Relief MuscleCAMPHOR (NATURAL)J.R. Watkins, LLC.1dc21c95-b419-4175-85f8-040b73060d372024-03-20WarningsExact identifier
application number: M017
Pain Relief Roll-On MuscleCAMPHOR (NATURAL)J.R. Watkins, LLC.d94ae654-ce25-4bff-b9bd-24a0e0e8568a2024-03-20WarningsExact identifier
application number: M017
Pain Relief MuscleCAMPHOR (NATURAL)J.R. Watkins, LLC.f8bff018-fb4f-47b4-b8f8-4a496aede3462024-03-20WarningsExact identifier
application number: M017
Rugby Arthritis Pain Relieving Topical AnalgesicCAPSAICINRugby Laboratories8f1bc075-97ac-4154-8768-0d878104c3ba2024-03-14WarningsExact identifier
application number: M017
Rugby Ice Blue External AnalgesicMENTHOL, UNSPECIFIED FORMRugby Laboratories2b65cb6a-4364-4770-b7b9-5c4637edd01a2024-03-14WarningsExact identifier
application number: M017
Leader Cooling Pain Relief Topical AnalgesicMENTHOL, UNSPECIFIED FORMCardinal Health, 110 dba LEADERfd06d17f-4dff-42a9-a84f-904809ceb9812024-03-13WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHOREROS GLOBALb3495c95-ba4b-9459-e053-2a95a90a710f2024-03-12WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONETRIFECTA PHARMACEUTICALS USA LLC1369e70f-7a61-7078-e063-6394a90a9a882024-03-11WarningsExact identifier
application number: M017
Pain Reliever CreamMENTHOL 10%, METHYL SALICYLATE 15%Trifecta Pharmaceuticals USA, LLC.130665d6-3de8-cb91-e063-6294a90a20832024-03-06WarningsExact identifier
application number: M017
Dermachange Aid Anti-ItchDIPHENHYDRAMINE HCLPrivate Label Beauty and Wellness12ed906c-d028-0ff7-e063-6394a90aaa522024-03-05WarningsExact identifier
application number: M017
Dermachange Cold TherapyMENTHOLPrivate Label Beauty and Wellness12ef7dd8-3da3-9c87-e063-6394a90ac9242024-03-05WarningsExact 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