Home NDC 59316-830 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 Ingredient Strength MENTHOL, UNSPECIFIED FORM 105 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2471404 Internal RxNorm lookup 2587602 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59316-830-37 Biofreeze Precision Relief Pen 34 mL in 1 BOTTLE LIQUID 34 5 59316-830-38 Biofreeze Precision Relief Pen 1 in 1 CARTON LIQUID 1 5 59316-830-38 Biofreeze Precision Relief Pen 34 mL in 1 BOTTLE LIQUID 34 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59316-830 BIOFREEZE PRECISION RELIEF PEN (MENTHOL) LIQUID [RB HEALTH (US) LLC] 4 Current NDC, Legacy NDC, 3 package rows 20241228_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 18 of 153 · 3,057 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59316-830-37 59316083037 34 mL in 1 BOTTLE (59316-830-37) 34 ml 2020-12-31 0000-00-00 No No Current 59316-830-38 59316083038 1 BOTTLE in 1 CARTON (59316-830-38) / 34 mL in 1 BOTTLE 1 bottle 2020-12-31 0000-00-00 No No Current