FDA.reportPublic FDA data

BIOFREEZE

Product NDC
59316-102
11-digit product format
593160102
Labeler code
59316
Product ID
59316-102_51b44481-a7ad-8a46-e063-6294a90aefda
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
2012-01-03
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
40 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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59316-10259316-102-15DDiscontinued by firm2026-10-23
excluded packagepackage59316-10259316-102-16DDiscontinued by firm2026-10-23
excluded packagepackage59316-10259316-102-25DDiscontinued by firm2026-10-23
excluded packagepackage59316-10259316-102-91DDiscontinued by firm2026-10-23
excluded packagepackage59316-10259316-102-92DDiscontinued by firm2026-10-23

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 · 36 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0559316-102-25d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0559316-102-16d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0559316-102-15d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2659316-102-25f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2659316-102-16f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2659316-102-15f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3159316-102-252ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3159316-102-162ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3159316-102-152ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2859316-102-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2859316-102-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2859316-102-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2159316-102-25cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2159316-102-16cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2159316-102-15cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1059316-102-25cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1059316-102-16cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1059316-102-15cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3159316-102-25302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3159316-102-16302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3159316-102-15302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2059316-102-25ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2059316-102-16ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2059316-102-15ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1059316-102-250efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1059316-102-160efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1059316-102-150efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0859316-102-25ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0859316-102-16ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0859316-102-15ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0359316-102-25367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0359316-102-16367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0359316-102-15367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0959316-102-25557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0959316-102-16557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0959316-102-15557ba5c1ecfa…9c80585c8c6e…

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
MENTHOL, UNSPECIFIED FORM40 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
83d5c2f2-2413-4d28-83b2-0808d0917b4dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-102-10BIOFREEZE5 mL in 1 BOTTLEGEL535
59316-102-11BIOFREEZE3 mL in 1 BOTTLEGEL335
59316-102-12BIOFREEZE89 mL in 1 BOTTLEGEL8935
59316-102-15BIOFREEZE89 mL in 1 BOTTLE, WITH APPLICATORGEL8935
59316-102-16BIOFREEZE89 mL in 1 BOTTLE, WITH APPLICATORGEL8935
59316-102-20BIOFREEZE118 mL in 1 BOTTLEGEL11835
59316-102-25BIOFREEZE118 mL in 1 BOTTLE, WITH APPLICATORGEL11835
59316-102-28BIOFREEZE237 mL in 1 BOTTLEGEL23735
59316-102-30BIOFREEZE473 mL in 1 BOTTLEGEL47335
59316-102-40BIOFREEZE946 mL in 1 BOTTLEGEL94635
59316-102-50BIOFREEZE3785 mL in 1 CONTAINERGEL378535
59316-102-80BIOFREEZE44 mL in 1 TUBEGEL4435
59316-102-90BIOFREEZE100 in 1 CARTONGEL10035
59316-102-91BIOFREEZE10 in 1 CARTONGEL1035
59316-102-92BIOFREEZE16 in 1 CARTONGEL1635
59316-102-98BIOFREEZE30 mL in 1 BOTTLEGEL3035
59316-102-80Biofreeze44 mL in 1 TUBEGEL441

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-102-12ML - Milliliter59316-1028c11b8a5-4f02-41bf-88b6-e4af8c4214f812018-09-05
59316-102-20ML - Milliliter59316-10263342204-7fd4-4732-9ec3-4df580a6e6ce12015-06-09
59316-102-28ML - Milliliter59316-102e8471990-bf89-42b8-8a43-721055ce764512018-09-05
59316-102-30ML - Milliliter59316-1028537e275-8662-4f2c-ae52-44981681af9912024-08-12
59316-102-40ML - Milliliter59316-102030b1aca-eae8-43da-9839-6522c8c985ac12024-08-12
59316-102-50ML - Milliliter59316-10235b2fa59-5fb2-4779-a89d-b84cda16782512024-08-12
59316-102-80ML - Milliliter59316-10239ef3edc-90e7-4701-bbcc-add710ddea6d12024-08-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ABIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
MENTHOLACTIVE MOIETYL7T10EIP3ABIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XBIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
ARCTIUM LAPPA ROOTINACTIVE INGREDIENT597E9BI3Z3BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
ARNICA MONTANA FLOWERINACTIVE INGREDIENTOZ0E5Y15PZBIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YDBIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
CAMPHOR (SYNTHETIC)INACTIVE INGREDIENT5TJD82A1ETBIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MBIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
FRANKINCENSEINACTIVE INGREDIENTR9XLF1R1WMBIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
ILEX PARAGUARIENSIS LEAFINACTIVE INGREDIENT1Q953B4O4FBIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSBIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
MELISSA OFFICINALIS LEAFINACTIVE INGREDIENT50D2ZE9219BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKBIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
WATERINACTIVE INGREDIENT059QF0KO0RBIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-102BIOFREEZE (MENTHOL) GEL [RB HEALTH (US) LLC]34Current NDC, Legacy NDC, 16 package rows20231114_83d5c2f2-2413-4d28-83b2-0808d0917b4d.zip
59316-102BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1Current NDC, Legacy NDC, 1 package rows20181108_f0c4d165-a242-4fb5-b2de-d64a825a29e9.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 64 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Painless Tattoo 1BENZOCAINESambria Pharmaceuticals, LLC2f8fdcac-b87a-4191-9504-480a473f95cc2025-11-12WarningsExact identifier
application number: M017
Painless Tattoo 2LIDOCAINESambria Pharmaceuticals, LLC180b2899-7699-40e2-974a-081a6ce2bca22025-11-12WarningsExact identifier
application number: M017
Painless Tattoo 3TETRACAINESambria Pharmaceuticals, LLC9c24dcff-3988-40eb-821a-fd4b0c85f5282025-11-12WarningsExact identifier
application number: M017
Tattoo Numbing Cream CoLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLC2a64b3ef-ed2d-49db-996d-f63ffecb5a1e2025-11-12WarningsExact identifier
application number: M017
Painless Tattoo NumbingLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLCefd3289f-dfb2-487c-a76f-00fe8af414e32025-11-12WarningsExact identifier
application number: M017
Now Numb Numbing CreamLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLCfed833f5-4f76-46e8-8ae1-655a9e576f702025-11-12WarningsExact identifier
application number: M017
Painless Tattoo Numbing CreamLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLC852504ec-d4fa-4cae-ba89-7ffb57df8efe2025-11-12WarningsExact identifier
application number: M017
Arte Maximum strength Numbing CreamLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLCe612a256-3f44-46db-bb6a-e550c2216fdc2025-11-12WarningsExact identifier
application number: M017
Hello SugarLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLC5f30254d-a28f-443d-8729-5c5dde4a02172025-11-12WarningsExact identifier
application number: M017
YULAM DIE DA WAN HUA PAIN RELIEVINGMENTHOL AND CAMPHORMADISON ONE ACME INC1ba3c31b-2737-4b55-a0ea-90013a1d8cf42025-11-12Warnings, Adverse reactionsExact identifier
application number: M017
TattooNumbLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLCd9c4d664-54de-40c2-8836-72b60e6d9ac02025-11-12WarningsExact identifier
application number: M017
BeardedMoneyLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLC35ff688b-75c5-4780-b294-192af780d7052025-11-12WarningsExact identifier
application number: M017
NeuroMed 7 Topical Pain ReliefLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLCf199f56b-d971-4cf8-834d-babb5c2ff81a2025-11-12WarningsExact identifier
application number: M017
NeuroMed Topical Anesthetic 7LIDOCAINE HYDROCHLORIDESambria Pharmaceuticals8a2b6b76-6bcc-4f52-b037-e6cbc74f83772025-11-12WarningsExact identifier
application number: M017
NeuroMed Topical Anesthetic 7LIDOCAINE HYDROCHLORIDESambria Pharmaceuticals67b25c37-db32-4980-88b0-b077123459392025-11-12WarningsExact identifier
application number: M017
NeuroMed Topical Analgesic LATETRACAINE HCLSambria Pharmaceuticals, Inc.3c1e3a1d-f42b-499d-a445-1d1d3dd26c192025-11-12WarningsExact identifier
application number: M017
NeuroMed FABENZOCAINESambria Pharmaceuticals, Inc.97345ed4-51c3-4221-852c-2cd563f333172025-11-12WarningsExact identifier
application number: M017
ZHENG GU SHUICAMPHOR, MENTHOLGUANGXI YULIN PHARMACEUTICAL GROUP CO LTD17552943-4f11-42d6-ad41-fbc53f2bbd9a2025-11-12Warnings, Adverse reactionsExact identifier
application number: M017
NeuroMed FABENZOCAINESambria Pharmaceuticals, Inc.605fc242-ad31-4aa9-bd86-fba4ddf0d3052025-11-12WarningsExact identifier
application number: M017
CAPZIXCAPSAICINToprail Chp Llc.a4555840-cf8f-45d8-90bb-3581102b58a72025-11-12WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111683BIOFREEZE 4 % Topical GelPSN83d5c2f2-2413-4d28-83b2-0808d0917b4d35
415974menthol 4 % Topical GelPSN83d5c2f2-2413-4d28-83b2-0808d0917b4d35
1111683menthol 0.04 MG/MG Topical Gel [Biofreeze]SBD83d5c2f2-2413-4d28-83b2-0808d0917b4d35
415974menthol 0.04 MG/MG Topical GelSCD83d5c2f2-2413-4d28-83b2-0808d0917b4d35
1111683Biofreeze 0.04 MG/MG Topical GelSY83d5c2f2-2413-4d28-83b2-0808d0917b4d35
1111683Biofreeze 4 % Topical GelSY83d5c2f2-2413-4d28-83b2-0808d0917b4d35
415974menthol 4 % Topical GelSY83d5c2f2-2413-4d28-83b2-0808d0917b4d35
1111683BIOFREEZE 4 % Topical GelPSNf0c4d165-a242-4fb5-b2de-d64a825a29e91
415974menthol 4 % Topical GelPSNf0c4d165-a242-4fb5-b2de-d64a825a29e91
1111683menthol 0.04 MG/MG Topical Gel [Biofreeze]SBDf0c4d165-a242-4fb5-b2de-d64a825a29e91
415974menthol 0.04 MG/MG Topical GelSCDf0c4d165-a242-4fb5-b2de-d64a825a29e91
1111683Biofreeze 0.04 MG/MG Topical GelSYf0c4d165-a242-4fb5-b2de-d64a825a29e91
1111683Biofreeze 4 % Topical GelSYf0c4d165-a242-4fb5-b2de-d64a825a29e91
415974menthol 4 % Topical GelSYf0c4d165-a242-4fb5-b2de-d64a825a29e91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59316-102-10593160102105 mL in 1 BOTTLE (59316-102-10) 5 ml2012-01-030000-00-00NoNoCurrent
59316-102-11593160102113 mL in 1 BOTTLE (59316-102-11) 3 ml2012-01-030000-00-00NoNoCurrent
59316-102-125931601021289 mL in 1 BOTTLE (59316-102-12) 89 ml2016-09-190000-00-00NoNoCurrent
59316-102-155931601021589 mL in 1 BOTTLE, WITH APPLICATOR89 mlHistorical
59316-102-165931601021689 mL in 1 BOTTLE, WITH APPLICATOR89 mlHistorical
59316-102-2059316010220118 mL in 1 BOTTLE (59316-102-20) 118 ml2012-01-030000-00-00NoNoCurrent
59316-102-2559316010225118 mL in 1 BOTTLE, WITH APPLICATOR (59316-102-25) 118 ml2012-01-032021-12-31NoNoCurrent
59316-102-2859316010228237 mL in 1 BOTTLE (59316-102-28) 237 ml2016-09-190000-00-00NoNoCurrent
59316-102-3059316010230473 mL in 1 BOTTLE (59316-102-30) 473 ml2012-01-030000-00-00NoNoCurrent
59316-102-4059316010240946 mL in 1 BOTTLE (59316-102-40) 946 ml2012-01-030000-00-00NoNoCurrent
59316-102-50593160102503785 mL in 1 CONTAINER (59316-102-50) 3785 ml2012-01-030000-00-00NoNoCurrent
59316-102-805931601028044 mL in 1 TUBE (59316-102-80) 44 ml2018-11-020000-00-00NoNoCurrent
59316-102-9059316010290100 BOTTLE in 1 CARTON (59316-102-90) / 5 mL in 1 BOTTLE (59316-102-10) 100 bottle2012-01-030000-00-00NoNoCurrent
59316-102-915931601029110 BOTTLE in 1 CARTON (59316-102-91) > 3 mL in 1 BOTTLE (59316-102-11) 10 bottle2012-01-030000-00-00NoNoCurrent
59316-102-925931601029216 BOTTLE in 1 CARTON (59316-102-92) > 3 mL in 1 BOTTLE (59316-102-11) 16 bottle2012-01-030000-00-00NoNoCurrent
59316-102-985931601029830 mL in 1 BOTTLE (59316-102-98) 30 ml2012-01-030000-00-00NoNoCurrent