Biofreeze Flexible Relief Strip

Product NDC
59316-004
11-digit product format
593160004
Labeler code
59316
Product ID
59316-004_51b597cc-806d-e160-e063-6394a90ac1be
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
PATCH
Route
TOPICAL
Labeler
Reckitt Benckiser LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-31
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
56 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM56 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui2566836

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
59316-004-01Biofreeze Flexible Relief Strip6 g in 1 PATCHPATCH65
59316-004-01Biofreeze Flexible Relief Strip1 in 1 POUCHPATCH15
59316-004-04Biofreeze Flexible Relief Strip4 in 1 CARTONPATCH45
59316-004-04Biofreeze Flexible Relief Strip6 g in 1 PATCHPATCH65

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-004BIOFREEZE FLEXIBLE RELIEF STRIP (MENTHOL) PATCH [RB HEALTH (US) LLC]4Current NDC, Legacy NDC, 4 package rows20241228_6ec26bae-e395-49aa-969e-8c653d6f0b27.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2566836menthol 5.6 % Medicated PatchPSN6ec26bae-e395-49aa-969e-8c653d6f0b275
2566836menthol 0.056 MG/MG Medicated PatchSCD6ec26bae-e395-49aa-969e-8c653d6f0b275
2566836menthol 5.6 % Medicated PatchSY6ec26bae-e395-49aa-969e-8c653d6f0b275

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59316-004-01593160004011 PATCH in 1 POUCH (59316-004-01) / 6 g in 1 PATCH1 patch2021-03-310000-00-00NoNoCurrent
59316-004-04593160004044 PATCH in 1 CARTON (59316-004-04) / 6 g in 1 PATCH4 patch2021-03-310000-00-00NoNoCurrent