Home NDC 59316-832 Biofreeze Day and Overnight
Product NDC 59316-832
11-digit product format 593160832
Labeler code 59316
Product ID 59316-832_51b59cc1-4a52-f6d3-e063-6394a90aea69
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form KIT
Labeler Reckitt Benckiser LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-05-22
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 Day and Overnight
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 420222 Internal RxNorm lookup 2109627 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59316-005-03 Biofreeze Day and Overnight 6 g in 1 PATCH PATCH 18 g in 3 0.3 g in 6g 3 59316-832-94 Biofreeze Day and Overnight 1 in 1 KIT KIT 1 3 59316-992-07 Biofreeze Day and Overnight 1 in 1 POUCH PATCH 0.05 g in 1g 3 59316-992-07 Biofreeze Day and Overnight 9 g in 1 PATCH PATCH 54 g in 6 0.05 g in 1g 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59316-832 BIOFREEZE DAY AND OVERNIGHT (MENTHOL) KIT [RB HEALTH (US) LLC] 3 Current NDC, 4 package rows 20241228_fb5c8f89-a720-ad32-e053-6294a90a2abe.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 18 of 153 · 3,057 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59316-005-03 59316000503 6 g in 1 PATCH 6 g Historical 59316-832-94 59316083294 1 KIT in 1 KIT (59316-832-94) * 1 PATCH in 1 POUCH (59316-992-07) / 9 g in 1 PATCH * 6 g in 1 PATCH (59316-005-03) 1 kit 2023-05-31 No No Current 59316-992-07 59316099207 1 in 1 POUCH Historical