FDA.reportPublic FDA data

Biofreeze Roll-On and Overnight Roll-On

Product NDC
59316-209
11-digit product format
593160209
Labeler code
59316
Product ID
59316-209_51e076b8-984a-b24a-e063-6294a90ae9c0
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
KIT
Labeler
Reckitt Benckiser LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-01
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 Roll-On and Overnight Roll-On
Listing expiration
2027-12-31

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
4d3dcb8f-2075-6bbc-e063-6394a90a4992Available 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
59316-205-14Biofreeze Roll-On and Overnight Roll-On74 mL in 1 BOTTLEGEL74 mL40 mg in 1mL5
59316-207-14Biofreeze Roll-On and Overnight Roll-On74 mL in 1 BOTTLEGEL74 mL40 mg in 1mL5
59316-209-14Biofreeze Roll-On and Overnight Roll-On1 in 1 BOTTLEKIT15
59316-209-14Biofreeze Roll-On and Overnight Roll-On2 in 1 KITKIT25

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 89 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Post-Treatment Repair CreamHYDROCORTISONEVi Medical Products Inc.ab8885a9-0778-28ff-e053-2995a90a2e122025-06-19WarningsExact identifier
application number: M017
MyDermLIDOCAINEInspec Solutions LLC.82d075d1-c92e-2097-e053-2991aa0ab1312025-06-18WarningsExact identifier
application number: M017
Walgreens Extra Small LidocaineLIDOCAINEWalgreen Co.dc838e47-d234-4ba5-9449-f645e99be9232025-06-18WarningsExact identifier
application number: M017
CLn Body MoisturizerCOLLOIDAL OAT MOISTURIZERTopMD Skin Care, Inc.2de3d68d-a540-d456-e063-6394a90a4b572025-06-18WarningsExact identifier
application number: M017
Aloe UP SPF 30 MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35967b33-bdfb-ee3c-e063-6294a90a75f62025-06-18WarningsExact identifier
application number: M017
Aloe Up SPF 50 MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35b9dcfa-05f3-3d7b-e063-6394a90a18f12025-06-18WarningsExact identifier
application number: M017
Aloe Up SPF 50 MineralZINC OXIDEAloe International, LLC35bc3621-f4e4-42d3-e063-6394a90a7aad2025-06-18WarningsExact identifier
application number: M017
Aloe Up SPF 50 Kids MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35cd16b0-bd81-8f68-e063-6294a90a3d8c2025-06-18WarningsExact identifier
application number: M017
Aloe Up SPF 50 Kids MineralZINC OXIDEAloe International, LLC35cd5542-947d-a042-e063-6394a90a13f82025-06-18WarningsExact identifier
application number: M017
Relieve Your PainMENTHOLProximity Capital Partners LLC dba Asutrac12369dd-8305-edaf-e053-2995a90a0d3d2025-06-18WarningsExact identifier
application number: M017
Melt Pain AwayCAPSAICINProximity Capital Partners LLC dba Asutraa95a11d7-a2ae-6654-e053-2a95a90a802c2025-06-18WarningsExact identifier
application number: M017
Recovery Roll-OnMENTHOL, CAMPHORPROXIMITY CAPITAL PARTNERS LLC DBA ASUTRAebc9630f-6d8b-e4f0-e053-2995a90a0b492025-06-18WarningsExact identifier
application number: M017
ProCure Hydrocortisone 1%HYDROCORTISONETwin Med LLC37cdfabc-1fdb-246a-e063-6394a90a008a2025-06-17WarningsExact identifier
application number: M017
ProCure Hydrocortisone 1%HYDROCORTISONETwin Med LLC37ce6c35-b211-43de-e063-6294a90ab7732025-06-17WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1%Sun Pharmaceutical Industries, Inc.312ddc8d-100e-cfac-e063-6294a90acd092025-06-16WarningsExact identifier
application number: M017
Curist 5% LidocaineLIDOCAINE 5%Little Pharma, Inc.f20241a2-c5b1-f124-e053-2995a90a891b2025-06-16WarningsExact identifier
application number: M017
Toast Screamin MentholMENTHOLIDEAZ, LLC37b48b1a-ef3d-afdc-e063-6294a90a66102025-06-16WarningsExact identifier
application number: M017
Toast Freezin ColdMENTHOL, METHYL SALICYLATEIDEAZ, LLC37b4d363-0099-8cd3-e063-6394a90a18d62025-06-16WarningsExact identifier
application number: M017
Earths Care Anti-ItchCAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORMDLC Laboratories, Inc.ba65f58a-d590-498a-b8e7-a3d78935d8802025-06-13WarningsExact identifier
application number: M017
LidocaineLIDOCAINEStratus Pharmaceuticals Inc5eb6574c-2066-4390-befc-8e5d2dd6ede22025-06-12WarningsExact 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59316-205-145931602051474 mL in 1 BOTTLE74 mlHistorical
59316-207-145931602071474 mL in 1 BOTTLE74 mlHistorical
59316-209-14593160209142 BOTTLE in 1 KIT (59316-209-14) / 1 KIT in 1 BOTTLE * 74 mL in 1 BOTTLE (59316-205-14) * 74 mL in 1 BOTTLE (59316-207-14) 2 bottle2026-04-01NoNoCurrent