FDA.reportPublic FDA data

Biofreeze

Product NDC
59316-833
11-digit product format
593160833
Labeler code
59316
Product ID
59316-833_51b57ded-2d7c-d540-e063-6394a90a4744
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
SPRAY
Route
TOPICAL
Labeler
Reckitt Benckiser LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-01
Substance
MENTHOL
Active strength
105 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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL105 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
1489073Internal RxNorm lookup
1489074Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
00bb462a-27d0-6f74-e063-6394a90a90ecAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-833-10Biofreeze89 mL in 1 BOTTLESPRAY8912
59316-833-20Biofreeze118 mL in 1 BOTTLESPRAY11812

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-833-10ML - Milliliter59316-833a7b60bb1-2302-473f-8bae-ed1aaafc2b7312024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-833BIOFREEZE (MENTHOL) SPRAY [RB HEALTH (US) LLC]10Current NDC, 2 package rows20240202_00bb462a-27d0-6f74-e063-6394a90a90ec.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 14 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Roll Pain AwayCAPSAICINPROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA547e647b-0205-221c-e063-6294a90a757c2026-06-17WarningsExact identifier
application number: M017
Roll Pain Away LemongrassCAPSAICINPROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA547ef5c0-bc31-d83e-e063-6394a90abfa62026-06-17WarningsExact identifier
application number: M017
Roll Pain Away LavenderCAPSAICINPROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA547ef2d9-f5c7-9de1-e063-6394a90a218b2026-06-17WarningsExact identifier
application number: M017
Velloryn EXTRA STRENGTH NEUROPATHYVELLORYN EXTRA STRENGTH NEUROPATHYGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd547f755f-c65c-37ef-e063-6394a90aa2202026-06-17WarningsExact identifier
application number: M017
Neoteric Diabetic Skin Care 4 oz.DIMETHICONERNA PHARMA LLC536f4e79-201b-7100-e063-6394a90a4f822026-06-16WarningsExact identifier
application number: M017
Medi First Extra Strength Itch ReliefDIPHENHYDRAMINE, ZINC ACETATEUnifirst First Aid Corporation54614e5b-8c72-d308-e063-6294a90a405d2026-06-16WarningsExact identifier
application number: M017
Blue Ice AnalgesicMENTHOLDelon Laboratories (1990) Ltd184ed488-6e62-40c6-bb71-1d523280fd6b2026-06-16WarningsExact identifier
application number: M017
Medi-First Hydrocortisone 1 % Anti-Itch CreamHYDROCORTISONEUnifirst First Aid Corporation49f04e5d-746d-cbe9-e063-6294a90a7e882026-06-16WarningsExact identifier
application number: M017
Lidozall ProLIDOCAINE HYDROCHLORIDEV2 Pharma LLCecc26ba7-4ff6-43e6-bfb9-91a9cbb509ff2026-06-16WarningsExact identifier
application number: M017
Tiger Balm Pain Relieving CoolCAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORMHaw Par Healthcare Ltd.41590ba1-32bb-4352-97ba-d6a3cc9d05462026-06-15WarningsExact identifier
application number: M017
HIGH POTENCY PAIN RELIEFCAPSAICINXiamen Weisiqi Technology Co., Ltd.543949a4-86ed-3734-e063-6394a90a24f22026-06-14WarningsExact identifier
application number: M017
Natucure HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD49e402ed-d314-e896-e063-6294a90a826b2026-06-14WarningsExact identifier
application number: M017
Nieapf NUMBINGLIDOCAINE 4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD49e7534f-bccf-4ef4-e063-6294a90aeb7f2026-06-14WarningsExact identifier
application number: M017
HEALMUSZ NUMBINGHEALMUSZ NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD49976ff7-49a4-e4ed-e063-6294a90a3f782026-06-14WarningsExact identifier
application number: M017
HEALMUSZ HEMORRHOID FISSURELIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID FISSUREJiangxi Yudexi Pharmaceutical Co., LTD4a342ac0-6a8d-3408-e063-6394a90a9a102026-06-14WarningsExact identifier
application number: M017
BOTASUN QUIT SMOKING NicotineNICOTINE18% MENTHOL 0.3% QUIT SMOKING NICOTINEJiangxi Yudexi Pharmaceutical Co., LTD4fa00db9-def5-dcfa-e063-6394a90ac8c22026-06-14WarningsExact identifier
application number: M017
HEALMUSZ NUMBINGMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4cbb7df5-5771-ce4b-e063-6294a90aab802026-06-14WarningsExact identifier
application number: M017
HEALMUSZ ECZEMAHYDROCORTISONE 1% ECZEMAJiangxi Yudexi Pharmaceutical Co., LTD511e54e0-2abe-fb76-e063-6294a90ada682026-06-14WarningsExact identifier
application number: M017
Hydrocortisone 1% Anti-ItchCreamHYDROCORTISONEAcme United Corporation5425fc2b-4f25-3e64-e063-6394a90aff492026-06-13WarningsExact identifier
application number: M017
Icy Hot Pain Relieving BalmMENTHOL AND METHYL SALICYLATEChattem, Inc.40c8c02f-fa5f-4e80-81a0-48271fa6f94b2026-06-12WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1489074BIOFREEZE 10.5 % Topical SprayPSN00bb462a-27d0-6f74-e063-6394a90a90ec12
1489073menthol 10.5 % Topical SprayPSN00bb462a-27d0-6f74-e063-6394a90a90ec12
1489074menthol 105 MG/ML Topical Spray [Biofreeze]SBD00bb462a-27d0-6f74-e063-6394a90a90ec12
1489073menthol 105 MG/ML Topical SpraySCD00bb462a-27d0-6f74-e063-6394a90a90ec12
1489074Biofreeze 10.5 % Topical SpraySY00bb462a-27d0-6f74-e063-6394a90a90ec12
1489074Biofreeze 105 MG/ML Topical SpraySY00bb462a-27d0-6f74-e063-6394a90a90ec12
1489073menthol 10.5 % Topical SpraySY00bb462a-27d0-6f74-e063-6394a90a90ec12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59316-833-105931608331089 mL in 1 BOTTLE (59316-833-10) 89 ml2023-12-01NoNoCurrent
59316-833-2059316083320118 mL in 1 BOTTLE (59316-833-20) 118 ml2026-01-01NoNoCurrent