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

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 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 70 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RELISPRAY NATURAL PAIN RELIEFMENTHOLMidas-Care Pharmaceuticals, Pvt. Ltdadc8a43c-19a1-4eb3-9820-b63f7b5e91ea2025-10-30WarningsExact identifier
application number: M017
Aveeno Anti-Itch ConcentratedZINC OXIDE, FERRIC OXIDE RED, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC07f4d4d0-9cee-46c3-bc71-2024abd31c9e2025-10-29WarningsExact identifier
application number: M017
zourunan Relieve itching cream ANTIFUNGALRELIEVE ITCHING CREAMGuchutang Biotechnology (Longyan) Co., Ltd41bb9ced-dde4-2998-e063-6394a90a81592025-10-29WarningsExact identifier
application number: M017
zourunan Intensive healing lotion. for ECZEMAINTENSIVE HEALING LOTIONGuchutang Biotechnology (Longyan) Co., Ltd41bad9f3-f1a7-e92c-e063-6394a90ad0ba2025-10-29WarningsExact identifier
application number: M017
Aromalief Pain Relief Cream Orange GingerMENTHOLMarketites LLC9e8d3611-ef1b-4ac6-e053-2995a90af28a2025-10-29WarningsExact identifier
application number: M017
Aromalief Calming Pain Relief Cream LavenderMENTHOLMarketites LLCb8197d52-ccfb-b008-e053-2995a90a0a532025-10-29WarningsExact identifier
application number: M017
Aromalief Cozy Vanilla Pain Relief CreamMENTHOLMarketites LLC3634e55e-8c62-a782-e063-6394a90a65082025-10-29WarningsExact identifier
application number: M017
BENOVA PAIN AND ITCH RELIEFMENTHOL, 0.11%BENOVA RX LLC42513ee2-8b40-a9f3-e063-6394a90a93862025-10-29WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINECVS Pharmacy7e9285fd-26d5-3eac-e053-2991aa0ae2db2025-10-29WarningsExact identifier
application number: M017
Coralite Ultra Strength Pain ReliefCAMPHOR MENTHOLUnited Exchange Corp.44ecf959-cc07-4adc-a500-075b2ee695482025-10-29WarningsExact identifier
application number: M017
GoodSense Pain ReliefLIDOCAINEGeiss, Destin & Dunn, Inc826f8da4-8468-ea0a-e053-2991aa0a66cb2025-10-28WarningsExact identifier
application number: M017
CALMADOLCAMPHOR, MENTHOL, METHYL SALICYLATEGRANDALL DISTRIBUTING, LLC31b7f84e-8b66-4d31-8e9c-279d0af2fe642025-10-28WarningsExact identifier
application number: M017
XRay DOLCAMPHOR, MENTHOL, AND METHYL SALICYLATEGenomma Lab USA, Inc.e07fef46-68d9-769c-e053-2a95a90aa0652025-10-28WarningsExact identifier
application number: M017
CVS Medicated HeatCAPSICUM EXTRACTCVS Pharmacy81cd1019-93a6-311b-e053-2991aa0a79972025-10-28WarningsExact identifier
application number: M017
Foster and ThriveLIDOCAINESTRATEGIC SOURCING SERVICES, LLCf950b072-d978-b629-e053-6394a90abfaf2025-10-28WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYPremier Brands of America, Inc.d3452573-f91f-f157-e053-2a95a90a1ad82025-10-27WarningsExact identifier
application number: M017
PRMENTHOLAmphp, Inc6f5b9e08-c445-4fac-e053-2a91aa0aa7372025-10-27WarningsExact identifier
application number: M017
LidocaineBURN RELIEFFoodhold USAb25dc0df-02d0-41ac-b36c-2c04baa77ef22025-10-27WarningsExact identifier
application number: M017
MentholMAXIMUM STRENGTH MEDICATED FOOT POWDER TALC FREEFSA Store Inc.fb3548c8-f202-dc50-e053-6394a90a5b302025-10-27WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE CONTINUOUS SPRAYPremier Brands of America, Inc.d344f68b-9b62-3029-e053-2995a90a16652025-10-27WarningsExact 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