Home NDC 76348-510 Mag 5 PT Cooling Formula Recovery Cream
Product NDC 76348-510
11-digit product format 763480510
Labeler code 76348
Product ID 76348-510_43e53829-1764-6b61-e063-6394a90a53de
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form CREAM
Route TOPICAL
Labeler RENU LABORATORIES, LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-03-19
Substance MENTHOL
Active strength 22.7 g/454g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 76348-510-16 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 76348-510-16 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 76348-510-16 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 76348-510-16 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 76348-510-16 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 76348-510-16 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 76348-510-16 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 Cooling Formula Recovery Cream
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 22.7 g/454g
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76348-510-04 Mag 5 PT Cooling Formula Recovery Cream 112 g in 1 JAR CREAM 112 8 76348-510-05 Mag 5 PT Cooling Formula Recovery Cream 1 in 1 BOX CREAM 1 8 76348-510-16 Mag 5 PT Cooling Formula Recovery Cream 454 g in 1 JAR CREAM 454 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76348-510 MAG 5 PT COOLING FORMULA RECOVERY CREAM (MENTHOL) CREAM [RENU LABORATORIES, LLC] 7 Current NDC, Legacy NDC, 3 package rows 20250330_a45cde67-64ec-643b-e053-2a95a90a10b6.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 26 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dr Sabharwals LIDOCAINE 4% GEL PATCH Dr. Sabharwal's Wound Care 102399b6-5be9-ee5e-e063-6394a90a3198 2026-04-02 Warnings Exact identifier application number: M017 TATTOO NUMBX NUMBING PAIN RELIEVING LIDOCAINE HYDROCHLORIDE Scyberco Ltd ac8eac04-ed5b-4c8e-9f9b-54d160b74606 2026-04-02 Warnings Exact identifier application number: M017 FifthPulse Hydrocortisone HYDROCORTISONE WeCare Products LLC f1fcb045-4a15-431b-9617-67eae9f87fbd 2026-04-02 Warnings Exact identifier application number: M017 ANIXIKE Cream MENTHOL 5% CREAM Jiangxi Yudexi Pharmaceutical Co., LTD 4e8510e6-c0c7-bf6b-e063-6294a90a3b00 2026-04-02 Warnings Exact identifier application number: M017 RAPID RELIEF 0.025% CAPSAICIN PAIN PATCH 83569 4ed549e8-0062-fb03-e063-6294a90aac65 2026-04-02 Warnings Exact identifier application number: M017 Itch Relief DIPHENHYDRAMINE HCL AND ZINC ACETATE CVS Pharmacy 7e921988-ec66-38dc-e053-2a91aa0a7346 2026-04-01 Warnings Exact identifier application number: M017 The Best Numbing Cream TBNC The Best Numbing Cream LLC 4ca3923b-f586-0aaf-e063-6294a90a16c1 2026-03-31 Warnings Exact identifier application number: M017 ChapStick Classic Medicated EXTERNAL ANALGESIC AND SKIN PROTECTANT LIP BALM Suave Brands Co., LLC 42798a6c-2d7e-80f6-e063-6294a90a105f 2026-03-31 Warnings Exact identifier application number: M017 Roll-On Pain Relief Liquid LIDOCAINE HCL HyVee Inc 4da6f6fb-b182-360f-e063-6294a90abdf3 2026-03-31 Warnings Exact identifier application number: M017 Hand Sanitizer ALCOHOL ProStat First Aid 4e54aecb-190f-3866-e063-6294a90a810a 2026-03-31 Warnings Exact identifier application number: M017 Burn Mist LIDOCAINE HYDROCHLORIDE Water-Jel Technologies c53ab9dd-351a-400b-b873-4f396e0af54d 2026-03-31 Warnings Exact identifier application number: M017 Satohap Lidocaine Hydrochloride 4 Percent Pain Relieving LIDOCAINE HYDROCHLORIDE Sato Pharmaceutical Co., Ltd. f7faddb2-5153-4fdd-a5ef-778182cef460 2026-03-31 Warnings Exact identifier application number: M017 ZENOL COOL METHYL SALICYLATE, L-MENTHOL BA TRADE INC 4e5c45f4-88ce-3a13-e063-6394a90a2a09 2026-03-31 Warnings Exact identifier application number: M017 Eagle Brand Medicated Roll On Refresh CAMPHOR, MENTHOL Borden Company (Private) Limited 091451fb-e30a-0012-e063-6394a90a3ba8 2026-03-31 Warnings Exact identifier application number: M017 Icy Hot Revive and Recovery Pain Relief No- Mess Roll On Refreshing Lime and Mint MENTHOL Chattem, Inc. b16ba9c2-23bf-4fdf-b44b-7abb9fec1911 2026-03-31 Warnings Exact identifier application number: M017 DR.PABU NUMBING LIDOCAINE 5% NUMBING Jiangxi Yudexi Pharmaceutical Co., LTD 4e3a3c6c-4821-76ea-e063-6294a90a8f96 2026-03-30 Warnings Exact identifier application number: M017 Doctor Jiao Antifungal Cream MICONAZOLE NITRATE Jiangxi Haiwei Pharmaceutical Co., Ltd. 4e3b231e-0642-bf63-e063-6394a90a905b 2026-03-30 Warnings Exact identifier application number: M017 CVS Muscle Balm and Roll-On CAMPHOR, MENTHOL CVS Pharmacy 4e40025a-070a-508e-e063-6394a90af5d7 2026-03-30 Warnings Exact identifier application number: M017 REGENECARE HA LIDOCAINE HCL MPM Medical LLC c3eec066-38e8-4617-b34d-2f72ffb7a324 2026-03-30 Warnings Exact identifier application number: M017 Softlips Naturals Medicated Matcha Honey CAMPHOR, MENTHOL The Mentholatum Company 4e03a721-73f3-b2f2-e063-6394a90a44e6 2026-03-27 Warnings Exact identifier application number: M017
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 76348-510-04 76348051004 112 g in 1 JAR 112 g Historical 76348-510-05 76348051005 1 JAR in 1 BOX (76348-510-05) / 112 g in 1 JAR (76348-510-04) 1 jar 2019-03-19 No No Current 76348-510-16 76348051016 454 g in 1 JAR (76348-510-16) 454 g 2019-03-19 No No Current