Biofreeze Day and Overnight

Product NDC
59316-832
11-digit product format
593160832
Labeler code
59316
Product ID
59316-832_154a81fb-5422-8048-e063-6394a90ac81c
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
KIT
Labeler
RB Health (US) LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-05-22
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Biofreeze Day and Overnight
Listing expiration
2027-12-31

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
59316-005-03Biofreeze Day and Overnight6 g in 1 PATCHPATCH18 g in 30.3 g in 6g3
59316-832-94Biofreeze Day and Overnight1 in 1 KITKIT13
59316-992-07Biofreeze Day and Overnight1 in 1 POUCHPATCH0.05 g in 1g3
59316-992-07Biofreeze Day and Overnight9 g in 1 PATCHPATCH54 g in 60.05 g in 1g3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-832-94EA - Each59316-83221677bce-bda1-418b-8359-81883b45724612024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-832BIOFREEZE DAY AND OVERNIGHT (MENTHOL) KIT [RB HEALTH (US) LLC]3Current NDC, 4 package rows20241228_fb5c8f89-a720-ad32-e053-6294a90a2abe.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59316-005-03593160005036 g in 1 PATCH6 gHistorical
59316-832-94593160832941 KIT in 1 KIT (59316-832-94) * 6 g in 1 PATCH (59316-005-03) * 1 PATCH in 1 POUCH (59316-992-07) / 9 g in 1 PATCH1 kit2023-05-31NoNoHistorical
59316-992-07593160992071 in 1 POUCHHistorical