Home NDC 76348-517 MAG 5 PT ROLL-ON PAIN RELIEF COOLING
Product NDC 76348-517
11-digit product format 763480517
Labeler code 76348
Product ID 76348-517_3237ca59-7ae0-d2ae-e063-6394a90a5212
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form LIQUID
Route TOPICAL
Labeler RENU LABORATORIES, LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-04-03
Substance MENTHOL
Active strength 4.2 g/84g
NDC exclude flag No
Listing certified through 2026-12-31
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 MAG 5 PT ROLL-ON PAIN RELIEF COOLING
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 4.2 g/84g
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 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 76348-517-01 MAG 5 PT ROLL-ON PAIN RELIEF COOLING 1 in 1 BOX LIQUID 1 2 76348-517-02 MAG 5 PT ROLL-ON PAIN RELIEF COOLING 1 in 1 BOX LIQUID 1 2 76348-517-03 MAG 5 PT ROLL-ON PAIN RELIEF COOLING 84 g in 1 BOTTLE, WITH APPLICATOR LIQUID 84 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76348-517 MAG 5 PT ROLL-ON PAIN RELIEF COOLING (MENTHOL) LIQUID [RENU LABORATORIES, LLC] 2 Current NDC, 3 package rows 20250410_31e4fa2c-3a98-d618-e063-6394a90aec1c.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 110 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 76348-517-01 76348051701 1 BOTTLE, WITH APPLICATOR in 1 BOX (76348-517-01) / 84 g in 1 BOTTLE, WITH APPLICATOR (76348-517-03) 2025-04-03 No No Current 76348-517-02 76348051702 1 BOTTLE, WITH APPLICATOR in 1 BOX (76348-517-02) / 84 g in 1 BOTTLE, WITH APPLICATOR (76348-517-03) 2025-04-03 No No Current 76348-517-03 76348051703 84 g in 1 BOTTLE, WITH APPLICATOR 84 g Historical