Home NDC 76348-996-01 SUGARLOAF ORGANICS MENTHOL REVIVE
Product NDC 76348-996
Requested package NDC 76348-996-01
11-digit product format 763480996
Labeler code 76348
Product ID 76348-996_3ce4cb1d-6369-4b5b-e063-6294a90a9e81
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 2023-04-25
Substance MENTHOL
Active strength 5.9 g/118mL
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 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 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 SUGARLOAF ORGANICS MENTHOL REVIVE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 5.9 g/118mL
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 76348-996-01 SUGARLOAF ORGANICS MENTHOL REVIVE 1 in 1 BOX CREAM 1 2 76348-996-04 SUGARLOAF ORGANICS MENTHOL REVIVE 118 mL in 1 JAR CREAM 118 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76348-996 SUGARLOAF ORGANICS MENTHOL REVIVE (MENTHOL) CREAM [RENU LABORATORIES, INC.] 1 Current NDC, 2 package rows 20230428_fa2f9539-b703-a00b-e053-6394a90ae309.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 72 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Buzz Away Sting Soothe MENTHOL Quantum, Inc. 419e34ea-17b2-ec32-e063-6394a90a603d 2025-10-20 Warnings Exact identifier application number: M017 Family Care Anti-Itch HYDROCORTISONE United Exchange Corp. deb09e89-9794-89a7-e053-2a95a90abdf8 2025-10-20 Warnings Exact identifier application number: M017 Numbing Cream MENTHOL FlexiGo Inc 41571c8f-332b-f423-e063-6394a90a8897 2025-10-20 Warnings Exact identifier application number: M017 Soothing Nerve Therapy MENTHOL Wise Consumer Products 40829d6b-5005-7ec9-e063-6294a90a970e 2025-10-20 Warnings Exact identifier application number: M017 Numbing Cream MENTHOL FlexiGo Inc 4146fd51-b18c-393d-e063-6294a90a4d9a 2025-10-20 Warnings Exact identifier application number: M017 Lidocaine 4% Maximum OTC Strength LIDOCAINE Cardinal Health 107, LLC 975031df-d46d-4098-b1c0-1c0c92b41995 2025-10-20 Warnings Exact identifier application number: M017 Cortizone 10 Intensive Healing HYDROCORTISONE Chattem, Inc. bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c 2025-10-20 Warnings Exact identifier application number: M017 Sting relief pad BENZOCAINE, ALCOHOL Guangdong Comfort Medical Products Co., Ltd. 6e905065-10a9-1ded-e053-2a91aa0a46a1 2025-10-19 Warnings Exact identifier application number: M017 CVS Cold and Hot MENTHOL CVS Pharmacy a44cec95-822a-40b6-e053-2995a90ae31c 2025-10-17 Warnings Exact identifier application number: M017 Sombra Max SOMBRA MAX Sombra Cosmetics Inc. 41623a46-e6e7-907e-e063-6394a90afc4c 2025-10-17 Warnings Exact identifier application number: M017 POMADA DRAGON PAIN RELIEVING CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE TELEVISA CONSUMER PRODUCTS USA c283291d-feaa-4f89-8fde-9e3957ea8b9f 2025-10-17 Warnings Exact identifier application number: M017 Ear Pain MD LIDOCAINE HYDROCHLORIDE Eosera Inc 78c4418f-7f0f-447f-a94f-d4c89a081af1 2025-10-17 Warnings Exact identifier application number: M017 WOFANLI Quit Smoking Nicotine Patches NICOTINE TRANSDERMAL PATCHES Shenzhen Paxi Trading Co., Ltd. 414217c1-ff3a-b556-e063-6394a90aa5db 2025-10-16 Warnings Exact identifier application number: M017 WOFANLI Quit Smoking Nicotine Patches NICOTINE TRANSDERMAL PATCHES Shenzhen Paxi Trading Co., Ltd. 41422d04-160b-51b2-e063-6294a90ab2b2 2025-10-16 Warnings Exact identifier application number: M017 WOFANLI Quit Smoking Nicotine Patches NICOTINE TRANSDERMAL PATCHES Shenzhen Paxi Trading Co., Ltd. 41427275-4c35-bbdf-e063-6294a90a14cf 2025-10-16 Warnings Exact identifier application number: M017 Dollar General Menthol Pain Relief Gel Rollon MENTHOL Dolgencorp, LLC 3a9b99e2-36b8-5dcf-e063-6394a90a382d 2025-10-16 Warnings Exact identifier application number: M017 Quality Choice HYDROCORTISONE Chain Drug Marketing Association, Inc. 24c3eb99-92ac-658c-e063-6394a90ab51f 2025-10-16 Warnings Exact identifier application number: M017 DentiCalm TOPICAL ANALGESIC NFUSE LLC 414e6f6f-06bb-b470-e063-6294a90af390 2025-10-16 Warnings Exact identifier application number: M017 WOFANLI Quit Smoking Nicotine Patches NICOTINE TRANSDERMAL PATCHES Shenzhen Paxi Trading Co., Ltd. 413008cd-d239-1453-e063-6394a90a74f2 2025-10-15 Warnings Exact identifier application number: M017 PERFORM LEO EXTENSIVE PAIN RELIEF LIDOCAINE, MENTHOL PERFORM LEO LLC f993ed5f-7dbb-4e3e-addf-f65b12f5cc48 2025-10-15 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 76348-996-01 76348099601 1 JAR in 1 BOX (76348-996-01) / 118 mL in 1 JAR (76348-996-04) 1 jar 2023-04-25 No No Current