FDA.reportPublic FDA data

Biofreeze

Product NDC
59316-887
11-digit product format
593160887
Labeler code
59316
Product ID
59316-887_51b56b5f-5a3c-cc70-e063-6294a90a4580
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol, Unspecified form
Dosage form
KIT
Labeler
Reckitt Benckiser LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-10
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui420222, 2109627

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-887-04BiofreezeMenthol1 in 1 KITKIT14
59316-992-32BiofreezeMenthol20 g in 1 PATCHPATCH20 g0.05 g in 1g4
59316-992-32BiofreezeMenthol1 in 1 POUCHPATCH0.05 g in 1g4
59316-992-33BiofreezeMenthol13 g in 1 PATCHPATCH13 g0.05 g in 1g4
59316-992-33BiofreezeMenthol1 in 1 POUCHPATCH0.05 g in 1g4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-887-04EA - Each59316-887f1b5bf5e-a838-449a-937a-1aad215af3ad12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-887BIOFREEZE MENTHOL (MENTHOL, UNSPECIFIED FORM) KIT [RB HEALTH (US) LLC]3Current NDC, Legacy NDC, 5 package rows20240927_3f2b1f48-2d78-4985-a046-9f72de5e1a9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2109627Biofreeze 5 % Medicated PatchPSN3f2b1f48-2d78-4985-a046-9f72de5e1a9b4
420222menthol 5 % Medicated PatchPSN3f2b1f48-2d78-4985-a046-9f72de5e1a9b4
2109627menthol 0.05 MG/MG Medicated Patch [Biofreeze]SBD3f2b1f48-2d78-4985-a046-9f72de5e1a9b4
420222menthol 0.05 MG/MG Medicated PatchSCD3f2b1f48-2d78-4985-a046-9f72de5e1a9b4
2109627Biofreeze 0.05 MG/MG Medicated PatchSY3f2b1f48-2d78-4985-a046-9f72de5e1a9b4
420222menthol 5 % Medicated PatchSY3f2b1f48-2d78-4985-a046-9f72de5e1a9b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59316-887-04593160887041 KIT in 1 KIT (59316-887-04) * 1 PATCH in 1 POUCH (59316-992-32) / 20 g in 1 PATCH * 1 PATCH in 1 POUCH (59316-992-33) / 13 g in 1 PATCH1 kit2022-03-100000-00-00NoNoCurrent
59316-992-325931609923220 g in 1 PATCH20 gHistorical
59316-992-335931609923313 g in 1 PATCH13 gHistorical