Home NDC 76348-517-01 MAG 5 PT ROLL-ON PAIN RELIEF COOLING
Product NDC 76348-517
Requested package NDC 76348-517-01
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 62 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Itch Eraser Gel DIPHENHYDRAMINE HCL Tender Corporation d/b/a Adventure Ready Brands 223c7cfd-6dc5-140a-e063-6394a90a8332 2025-11-17 Warnings Exact identifier application number: M017 Calamine Plus Pramoxine HCl CALAMINE PLUS SPRAY Kroger Co. 6b3e7aac-395f-48cf-9c5e-f7e163724aef 2025-11-17 Warnings Exact identifier application number: M017 Calamine Plus Pramoxine HCl CALAMINE PLUS SPRAY HY-VEE, INC 415ecfe9-3145-f23e-e063-6394a90adfd8 2025-11-17 Warnings Exact identifier application number: M017 AY BENDITO - CBD CAMPHOR, MENTHOL AY BENDITO INTERNATIONAL, INC 04b1d605-60aa-56f4-e063-6294a90ae760 2025-11-17 Warnings Exact identifier application number: M017 AY BENDITO - CBD CAMPHOR, MENTHOL AY BENDITO INTERNATIONAL, INC 0f1406fe-3a2f-bf36-e063-6294a90a7e5e 2025-11-17 Warnings Exact identifier application number: M017 AY BENDITO CBD MENTHOL, CAMPHOR AY BENDITO INTERNATIONAL, INC 30a1c6b7-e37e-32c2-e063-6394a90aa354 2025-11-17 Warnings Exact identifier application number: M017 ETERNAL SPIRIT BEAUTY PAINLESS WITH CBD 3000 MENTHOL, CAMPHOR Worldwide Cosmetics, Inc 0816cc8f-8d0b-de27-e063-6294a90a8a9d 2025-11-17 Warnings Exact identifier application number: M017 JUST CBD ROLL-ON COOLING MENTHOL Just Brands LLC f6538e3e-4663-679c-e053-2995a90a87b5 2025-11-17 Warnings Exact identifier application number: M017 JUST CBD ROLL-ON WARMING CAMPHOR Just Brands LLC f65455d7-04a9-6217-e053-2995a90a7c90 2025-11-17 Warnings Exact identifier application number: M017 JUST CBD - CBD AND THC ULTRA RELIEF MENTHOL, CAMPHOR Just Brands LLC f664eb79-8897-3a49-e053-2995a90a37b4 2025-11-17 Warnings Exact identifier application number: M017 JUST CBD RELIEF SOOTHING LIDOCAINE HCL Just Brands LLC f9aff6e7-5702-f61c-e053-6294a90aa66f 2025-11-17 Warnings Exact identifier application number: M017 JUST CBD SOOTHING MENTHOL, CAMPHOR Just Brands LLC 0abece07-976c-4881-e063-6294a90a5c1b 2025-11-17 Warnings Exact identifier application number: M017 Blue-Emu Thrive Pain Relief Cream TRIPELENNAMINE 0.5% Kingsway Pharmaceuticals dba NFI, LLC a4ba6787-c99b-4bf2-9f8f-e923ef976212 2025-11-14 Warnings Exact identifier application number: M017 CVS Cooling Patch MENTHOL CVS Pharmacy 42d97e29-f32d-a31b-e063-6394a90a88d8 2025-11-14 Warnings Exact identifier application number: M017 Lidocaine LIDOCAINE Marlex Pharmaceuticals Inc 4de2bc60-dc4a-4417-984f-eabab0e926a6 2025-11-14 Warnings Exact identifier application number: M017 EXTREME EMU MENTHOL, METHYL SALICYLATE Renu Laboratories, LLC 4393b57b-1e70-b8dd-e063-6294a90ae748 2025-11-14 Warnings Exact identifier application number: M017 4x Medicated Toothache and Gum Cream BENZOCAINE Kroger a8c5090a-24f9-4e73-e053-2a95a90acca0 2025-11-14 Warnings Exact identifier application number: M017 PM Toothache Relief BENZOCAINE CVS 0a5a8cd0-d680-8a0f-e063-6294a90aa65c 2025-11-14 Warnings Exact identifier application number: M017 PM Toothache Relief BENZOCAINE Walgreens e816f742-fba9-3c12-e053-2a95a90a192f 2025-11-14 Warnings Exact identifier application number: M017 4x Medicated Toothache and Gum Cream BENZOCAINE Walgreens a71c2092-4ece-b82e-e053-2995a90ac933 2025-11-14 Warnings Exact identifier application number: M017
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description 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