FDA.reportPublic FDA data

Biofreeze Overnight Roll-on

Product NDC
59316-207
11-digit product format
593160207
Labeler code
59316
Product ID
59316-207_51e06d5e-11fe-5814-e063-6294a90a2736
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
Reckitt Benckiser LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-16
Substance
MENTHOL
Active strength
40 mg/mL
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 Roll-on
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL40 mg/mL

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
415974Internal RxNorm lookup
1111683Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f67d7b7a-8922-73f6-e053-2995a90a2e80Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-207-14Biofreeze Roll-On and Overnight Roll-On74 mL in 1 BOTTLEGEL74 mL40 mg in 1mL5
59316-207-14Biofreeze Overnight Roll-on74 mL in 1 BOTTLEGEL743

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-207-14ML - Milliliter59316-207984f94ed-b81d-4470-a2af-d26d054baea712024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-207BIOFREEZE OVERNIGHT ROLL-ON (MENTHOL) GEL [RB HEALTH (US) LLC]2Current NDC, 1 package rows20241228_f67d7b7a-8922-73f6-e053-2995a90a2e80.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 96 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Pain ReliefMENTHOL 10.5%CVSd0ea80ce-38b2-acde-e053-2995a90a47e52025-03-31WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEA2A Integrated Pharmaceuticals, LLC31431866-6fb5-2acd-e063-6294a90ac5202025-03-31WarningsExact identifier
application number: M017
Citrus Cleansing Foot Soak and Body SoakCAMPHORSANSAR, LLCf136616d-9f32-4e55-a495-b7466fd685262025-03-28WarningsExact identifier
application number: M017
Zpol ULTRAMENTHOL, METHYL SALICYLATELaboratorios Zepol S.A.1a1433a6-8d04-96df-e063-6394a90a987b2025-03-27WarningsExact identifier
application number: M017
Muscle Recovery Foot Soak and Body SoakCAMPHORSANSAR, LLC1c347267-b653-41bf-9967-7feff17c38af2025-03-27WarningsExact identifier
application number: M017
Soothing Lavender Foot Soak and Body SoakCAMPHORSANSAR, LLCef26523a-b2f2-466e-89ad-f293cd64decb2025-03-27WarningsExact identifier
application number: M017
Achelon Lidocaine PatchLIDOCAINE PATCH 4%Achelon, Inc31408e21-e58d-6db5-e063-6294a90aa4bc2025-03-26WarningsExact identifier
application number: M017
Achelon Lidocaine PatchLIDOCAINE PATCH 4%Achelon, Inc3143bb72-2969-d66e-e063-6294a90a46042025-03-26WarningsExact identifier
application number: M017
Parche LeonCAPSAICIN, CAMPHOR, MENTHOLPharmadel LLCa8f266fa-6e43-559e-e053-2995a90a2c752025-03-26WarningsExact identifier
application number: M017
Adellina Numbing CreamLIDOCAINEGuangzhou Haishi Biological Technology Co., Ltd.314a83fe-8bdb-766f-e063-6294a90a61c62025-03-26WarningsExact identifier
application number: M017
HealthWise Lidocaine Plus Menthol PatchLIDOCAINE AND MENTHOLVeridian Healthcare312f15fe-9297-2dc2-e063-6294a90a6f4d2025-03-25WarningsExact identifier
application number: M017
HealthWise Lidocaine PatchLIDOCAINE 4%Veridian Healthcare3130729d-1679-90cd-e063-6294a90a21e62025-03-25WarningsExact identifier
application number: M017
HealthWise Lidocaine PatchLIDOCAINE 4%Veridian Healthcare31314dda-6199-574d-e063-6394a90aae7a2025-03-25WarningsExact identifier
application number: M017
RWSEFK Lidocaine Pain Relief Gel-PatchLIDOCAINE PAIN RELIEF GEL-PATCHHenan Enokon Medical Instrument Co., Ltd.31366793-f8a6-a2c4-e063-6294a90acbfc2025-03-25WarningsExact identifier
application number: M017
Forticept Wounds and Burns HydrogelBENZETHONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDELidan, inc.c6f58b63-9838-4ff4-8b1a-de2d41d6cf5f2025-03-25WarningsExact identifier
application number: M017
MQ Pain Relieving PatchPAIN RELIEVING PATCHZhengzhou Miaoqi Pharmaceutical Technology Co., Ltd0978ff22-c357-e266-e063-6394a90a98a42025-03-24WarningsExact identifier
application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)LIDOCAINE AND MENTHOL PATCHAdvanced Rx of Tennessee, LLC30c97646-db06-df84-e063-6394a90a77432025-03-20WarningsExact identifier
application number: M017
Carmex Classic Lip Balm MedicatedCAMPHOR (SYNTHETIC), PETROLATUMCarma Laboratories, Inc.fb6eb93b-7dc0-4b6f-bfe1-1a7b47588e572025-03-20WarningsExact identifier
application number: M017
Carmex Variety Pack Classic Medicated Lip Balm Daily Care Lip Balm SPFCAMPHOR (SYNTHETIC), WHITE PETROLATUM OCTINOXATE, OXYBENZONE, AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECarma Laboratories, Inc.5f904369-5f21-4907-98de-df23bce308232025-03-20WarningsExact identifier
application number: M017
DermaCort Anti-itchHYDROCORTISONEMelaleuca, Inc.24044b0f-dd1e-4762-82b8-7a28b08c2f772025-03-20WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111683BIOFREEZE 4 % Topical GelPSN4d3dcb8f-2075-6bbc-e063-6394a90a49925
415974menthol 4 % Topical GelPSN4d3dcb8f-2075-6bbc-e063-6394a90a49925
1111683menthol 0.04 MG/MG Topical Gel [Biofreeze]SBD4d3dcb8f-2075-6bbc-e063-6394a90a49925
415974menthol 0.04 MG/MG Topical GelSCD4d3dcb8f-2075-6bbc-e063-6394a90a49925
1111683Biofreeze 0.04 MG/MG Topical GelSY4d3dcb8f-2075-6bbc-e063-6394a90a49925
1111683Biofreeze 4 % Topical GelSY4d3dcb8f-2075-6bbc-e063-6394a90a49925
415974menthol 4 % Topical GelSY4d3dcb8f-2075-6bbc-e063-6394a90a49925
1111683BIOFREEZE 4 % Topical GelPSNf67d7b7a-8922-73f6-e053-2995a90a2e803
415974menthol 4 % Topical GelPSNf67d7b7a-8922-73f6-e053-2995a90a2e803
1111683menthol 0.04 MG/MG Topical Gel [Biofreeze]SBDf67d7b7a-8922-73f6-e053-2995a90a2e803
415974menthol 0.04 MG/MG Topical GelSCDf67d7b7a-8922-73f6-e053-2995a90a2e803
1111683Biofreeze 0.04 MG/MG Topical GelSYf67d7b7a-8922-73f6-e053-2995a90a2e803
1111683Biofreeze 4 % Topical GelSYf67d7b7a-8922-73f6-e053-2995a90a2e803
415974menthol 4 % Topical GelSYf67d7b7a-8922-73f6-e053-2995a90a2e803

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59316-207-145931602071474 mL in 1 BOTTLE (59316-207-14) 74 ml2023-03-16NoNoCurrent