FDA.reportPublic FDA data

Biofreeze

Product NDC
59316-114
11-digit product format
593160114
Labeler code
59316
Product ID
59316-114_51b43faa-c82a-4053-e063-6294a90a3c20
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
2014-02-19
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
105 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59316-11459316-114-50DDiscontinued by firm2026-09-09

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Additional Listing Data#

Finished product
Yes
Brand name base
Biofreeze
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM105 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
4c798b06-6ee5-41d1-8a14-f6889512ade3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-114-10Biofreeze89 mL in 1 BOTTLESPRAY8921
59316-114-25Biofreeze118 mL in 1 BOTTLE, SPRAYSPRAY11821
59316-114-30Biofreeze473 mL in 1 BOTTLE, SPRAYSPRAY47321
59316-114-50Biofreeze1 mL in 1 PACKETSPRAY121
59316-114-50Biofreeze10 in 1 BOXSPRAY1021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-114-10ML - Milliliter59316-11434d03209-6552-449d-85d4-80c70328794812018-09-05
59316-114-25ML - Milliliter59316-114cf2515ba-bce7-4676-bd56-90f07f8450f712024-08-12
59316-114-30ML - Milliliter59316-11418baaf7f-09d9-4346-8fb2-3dbcf47bf5a112024-08-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ABIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]4
MENTHOLACTIVE MOIETYL7T10EIP3ABIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MBIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]4
ARNICA MONTANAINACTIVE INGREDIENTO80TY208ZWBIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]4
BERRYINACTIVE INGREDIENTFV3431923ZBIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]4
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YDBIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]4
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XBIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]4
DIMETHYL SULFONEINACTIVE INGREDIENT9H4PO4Z4FTBIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]4
ECHINACEA, UNSPECIFIEDINACTIVE INGREDIENT4N9P6CC1DXBIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]4
ILEX PARAGUARIENSIS LEAFINACTIVE INGREDIENT1Q953B4O4FBIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]4
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSBIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]4
JUNIPERUS COMMUNIS WHOLEINACTIVE INGREDIENT464910T5N9BIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]4
WATERINACTIVE INGREDIENT059QF0KO0RBIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-114BIOFREEZE (MENTHOL) SPRAY [RB HEALTH (US) LLC]20Current NDC, Legacy NDC, 5 package rows20241228_4c798b06-6ee5-41d1-8a14-f6889512ade3.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 1 of 155 · 3,098 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Inknows Lidocaine Pain Relief Gel-PatchLIDOCAINE PAIN RELIEF GEL-PATCHHenan Enokon Medical Instrument Co., Ltd.59eb9c12-9e00-0171-e063-6394a90a83422026-08-25WarningsExact identifier
application number: M017
LidomarLIDOMAROncora Pharma, LLC215bfdca-60bf-480b-b02e-902de52fe5e82026-08-25WarningsExact identifier
application number: M017
HEEL PAIN RELIEF ROLL-ONLIDOCAINE AND MENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.59c7e13f-b9ea-023a-e063-6294a90a79e02026-08-24WarningsExact identifier
application number: M017
KNEE PAIN RELIEF ROLL-ONLIDOCAINE AND MENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.59c8b33a-7d4f-2c6e-e063-6394a90a79292026-08-24WarningsExact identifier
application number: M017
Bovonte Numbing CreamNUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5958cc29-c449-56a7-e063-6394a90a960b2026-08-24WarningsExact identifier
application number: M017
JELVOXA NECK PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.59a3d60a-26b5-e6a6-e063-6294a90a42bd2026-08-22WarningsExact identifier
application number: M017
JELVOXA DMSOCAMPHOR CAPSAICIN MENTHOLWuhan Ruihengjie Technology Co., Ltd.59a43e2c-d258-34b5-e063-6394a90a09bf2026-08-22WarningsExact identifier
application number: M017
Capsaicin 0.035 PercentCAPSAICINPreferred Pharmaceuticals Inc.0fabc025-4208-45f5-b3c2-543ae3a2df412026-08-21WarningsExact identifier
application number: M017
ClaravieHYDROCORTISONE ACETATEGentell LLC598d224b-d12e-89bf-e063-6394a90a84dc2026-08-21WarningsExact identifier
application number: M017
ETERNAL SPIRIT BEAUTY PAINLESS PAIN RELIEVINGMENTHOL, CAMPHORWorldwide Cosmetics, Inc3b8c2419-7a78-2731-e054-00144ff8d46c2026-08-21WarningsExact identifier
application number: M017
Enokon Lidocaine Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHHenan Enokon Medical Instrument Co., Ltd.5976e667-e506-1d11-e063-6394a90a68092026-08-20WarningsExact identifier
application number: M017
MQUPIN TIGER PatchTIGER PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.5977cbb5-94c7-cb24-e063-6294a90a2e072026-08-20WarningsExact identifier
application number: M017
MQUPIN Nicotine PatchesNICOTINE PATCHESZhengzhou Miaoqi Medical Technology Co., Ltd.5978258a-549e-50e6-e063-6394a90a3d862026-08-20WarningsExact identifier
application number: M017
ClaravieCAMPHORGentell LLC5978bdab-5359-be9a-e063-6394a90a5a322026-08-20WarningsExact identifier
application number: M017
Rugby PAIN RELIEF PATCHESLIDOCAINERUGBY LABORATORIESb34e40c8-a257-46cf-9399-f55df9b4102d2026-08-20WarningsExact identifier
application number: M017
MAXIMUM STRENGTH Lidocaine Plus MentholLIDOCAINE, MENTHOLARMY AND AIR FORCE EXCHANGE SERVICE60f72061-d264-424e-b396-5a609076d3522026-08-20WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET PAIN RELIEF5980c527-6bcb-a846-e063-6294a90a07882026-08-20WarningsExact identifier
application number: M017
Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEAmerisource Bergen5fb5e5ce-b268-4444-8b63-ea7ea6abf2692026-08-20WarningsExact identifier
application number: M017
Dr. Scholls Blister Pain Relief Complete KitLIDOCAINEScholl's Wellness Company LLC58c2b35c-e1ed-7ea8-e063-6294a90a14942026-08-19WarningsExact identifier
application number: M017
Dr. Scholls Blister Pain Relief Complete KitLIDOCAINEScholl's Wellness Company LLC585e740b-e4fa-d2aa-e063-6294a90a09822026-08-19WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1489074BIOFREEZE 10.5 % Topical SprayPSN4c798b06-6ee5-41d1-8a14-f6889512ade321
1489073menthol 10.5 % Topical SprayPSN4c798b06-6ee5-41d1-8a14-f6889512ade321
1489074menthol 105 MG/ML Topical Spray [Biofreeze]SBD4c798b06-6ee5-41d1-8a14-f6889512ade321
1489073menthol 105 MG/ML Topical SpraySCD4c798b06-6ee5-41d1-8a14-f6889512ade321
1489074Biofreeze 10.5 % Topical SpraySY4c798b06-6ee5-41d1-8a14-f6889512ade321
1489074Biofreeze 105 MG/ML Topical SpraySY4c798b06-6ee5-41d1-8a14-f6889512ade321
1489073menthol 10.5 % Topical SpraySY4c798b06-6ee5-41d1-8a14-f6889512ade321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59316-114-105931601141089 mL in 1 BOTTLE (59316-114-10) 89 ml2016-09-190000-00-00NoNoCurrent
59316-114-2559316011425118 mL in 1 BOTTLE, SPRAY (59316-114-25) 118 ml2014-02-190000-00-00NoNoCurrent
59316-114-3059316011430473 mL in 1 BOTTLE, SPRAY (59316-114-30) 473 ml2014-02-190000-00-00NoNoCurrent
59316-114-505931601145010 PACKET in 1 BOX (59316-114-50) > 1 mL in 1 PACKET10 packet2014-02-192021-12-31NoNoCurrent