FDA.reportPublic FDA data

Biofreeze Precision Relief Pen

Product NDC
59316-830
11-digit product format
593160830
Labeler code
59316
Product ID
59316-830_51e07cc8-735b-2dce-e063-6394a90af835
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
Reckitt Benckiser LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-31
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
105 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Biofreeze Precision Relief Pen
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
2471404Internal RxNorm lookup
2587602Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b4cc1db5-a33f-17bc-e053-2995a90ab7ebAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-830-37Biofreeze Precision Relief Pen34 mL in 1 BOTTLELIQUID345
59316-830-38Biofreeze Precision Relief Pen1 in 1 CARTONLIQUID15
59316-830-38Biofreeze Precision Relief Pen34 mL in 1 BOTTLELIQUID345

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-830-37ML - Milliliter59316-8309e55e639-c3b5-4b51-8df2-1c8bf726bafd12024-08-12
59316-830-38ML - Milliliter59316-830e380948a-99a2-4e09-b438-300c4fc2cd4412024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-830BIOFREEZE PRECISION RELIEF PEN (MENTHOL) LIQUID [RB HEALTH (US) LLC]4Current NDC, Legacy NDC, 3 package rows20241228_b4cc1db5-a33f-17bc-e053-2995a90ab7eb.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 157 · 3,129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JenGufun LIDOCAINE KNEE PatchLIDOCAINE KNEE PATCHHenan Kangdi Medical Devices Co., Ltd.5b1d8508-b993-7a8d-e063-6294a90ae3062026-09-10WarningsExact identifier
application number: M017
Wart Corn RemoverSALICYLIC ACIDHONG KONG FOREVER YOUNG TRADING CO., LIMITED5b0cd6e0-f220-4ebd-e063-6294a90ade672026-09-09WarningsExact identifier
application number: M017
Magic CreamPAIN RELIEVING OINTMENTJiangxi Baikang Medical Products Co., Ltd.5b0f2515-47e9-603f-e063-6294a90af9d42026-09-09WarningsExact identifier
application number: M017
Burn GelLIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9d3e9be-1036-fad0-e053-2a95a90a6efe2026-09-09WarningsExact identifier
application number: M017
4% Lidocaine Pain Relief PatchLIDOCAINE 4%Guangxi Keyun E-commerce Co., Ltd.5b197cd8-542f-38b4-e063-6294a90ad7d32026-09-09WarningsExact identifier
application number: M017
Pain Relieving Lidocaine PatchLIDOCAINEYYBA CORPaf8c84fd-224c-72b3-e053-2a95a90a95682026-09-07WarningsExact identifier
application number: M017
American Safety First AidLIDOCAINE HCLOrazen Incea2f776b-dfd0-6ce4-e053-2995a90af0092026-09-07WarningsExact identifier
application number: M017
MEDI-FIRST Topical AnalgesicLIDOCAINE HCIUltra Distributors Incb6f288f7-9ae3-215e-e053-2a95a90aedf62026-09-07WarningsExact identifier
application number: M017
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf508434f-5948-7134-e053-2a95a90a03d72026-09-05WarningsExact identifier
application number: M017
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf522fb0b-3d86-b228-e053-2a95a90a55e92026-09-05WarningsExact identifier
application number: M017
SurviveX Anti-itch CreamSURVIVEX HYDROCORTISONENantong Health & Beyond Hygienic Products Inc.5a7a1141-d3b1-0ee8-e063-6294a90a16aa2026-09-04WarningsExact identifier
application number: M017
NeuroNesic Pain Relieving CreamCAPSAICINBlaine Labs Inc.7107c13d-bf59-4c0a-84fe-725a9fca26912026-09-04WarningsExact identifier
application number: M017
FREEZE EASEMENTHOL 4%Global America Group LLC16553eda-ec34-485a-a11c-f51260efd9fa2026-09-03WarningsExact identifier
application number: M017
Neoteric Diabetic Skin Care 1 oz.DIMETHICONERNA PHARMA LLC5a944486-9591-f583-e063-6394a90aa04b2026-09-03WarningsExact identifier
application number: M017
Equate Menthol Pain RelievingMENTHOLWal-Mart Stores Incd5b0a7f1-4e23-426b-bb7e-aaa251ad4ffc2026-09-03WarningsExact identifier
application number: M017
ZHI TechnologiesLIDOCAINE, MENTHOLZHI Technologies, Inc.6717e995-4d2d-49e8-8ecf-7c62557dfdef2026-09-03WarningsExact identifier
application number: M017
Komxsum LIDOCAINE CreamLIDOCAINE 4% CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9feae0-9be4-e736-e063-6294a90abe552026-09-03WarningsExact identifier
application number: M017
FREEZE EASE Roll-OnMENTHOLGlobal America Group LLC1869cc0d-a056-45de-aede-23b09b61ed122026-09-02WarningsExact identifier
application number: M017
Gaimoa Lidocaine Pain Relief Gel PatchesLIDOCAINE PAIN RELIEF GEL PATCHESHenan Enokon Medical Instrument Co., Ltd.5a68fe67-5c15-af9a-e063-6294a90a7ec12026-09-01WarningsExact identifier
application number: M017
CVS Cortisone LiquidHYDROCORTISONECVS Pharmacy42df45a9-d449-090a-e063-6394a90a9ee42026-09-01WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2587602Biofreeze 10.5 % Topical SolutionPSNb4cc1db5-a33f-17bc-e053-2995a90ab7eb5
2471404menthol 10.5 % Topical SolutionPSNb4cc1db5-a33f-17bc-e053-2995a90ab7eb5
2587602menthol 105 MG/ML Topical Solution [Biofreeze]SBDb4cc1db5-a33f-17bc-e053-2995a90ab7eb5
2471404menthol 105 MG/ML Topical SolutionSCDb4cc1db5-a33f-17bc-e053-2995a90ab7eb5
2587602Biofreeze 10.5 % Topical SolutionSYb4cc1db5-a33f-17bc-e053-2995a90ab7eb5
2587602Biofreeze 105 MG/ML Topical SolutionSYb4cc1db5-a33f-17bc-e053-2995a90ab7eb5
2471404menthol 10.5 % Topical SolutionSYb4cc1db5-a33f-17bc-e053-2995a90ab7eb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59316-830-375931608303734 mL in 1 BOTTLE (59316-830-37) 34 ml2020-12-310000-00-00NoNoCurrent
59316-830-38593160830381 BOTTLE in 1 CARTON (59316-830-38) / 34 mL in 1 BOTTLE1 bottle2020-12-310000-00-00NoNoCurrent