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 80 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Yeheal CAMPHOR, MENTHOL, ISOPROPYL ALCOHOL Shenzhen Yeheal Biotechnology Co., Ltd 3cf1bc74-3060-6d63-e063-6294a90a9f5c 2025-08-22 Warnings Exact identifier application number: M017 Dermedial Anti-Ouch MENTHOL Natures Formulae Health Products Ltd. 3ce29160-3964-e435-e063-6394a90abb38 2025-08-21 Warnings Exact identifier application number: M017 SUGARLOAF ORGANICS MENTHOL REVIVE MENTHOL RENU LABORATORIES, LLC fa2f9539-b703-a00b-e053-6394a90ae309 2025-08-21 Warnings Exact identifier application number: M017 ndc (package): 76348-996-01 ndc (product): 76348-996 ndc11 (package): 76348099601 Camphor 4% Plus Menthol 10% CAMPHOR 4% PLUS MENTHOL 10% PureTek Corporation 3cab26e4-e377-f26a-e063-6394a90a17af 2025-08-20 Warnings Exact identifier application number: M017 Capsaicin 0.035% Cream CAPSAICIN 0.035% CREAM Puretekcorp 3cbc73b6-8c58-8f23-e063-6394a90a71a3 2025-08-20 Warnings Exact identifier application number: M017 Game On MENTHOL, METHYL SALICYLATE Natural Essentials, Inc. 3cd20f1f-033f-f698-e063-6294a90a89eb 2025-08-20 Warnings Exact identifier application number: M017 ELAIMEI Numbing Cream LIDOCAINE 4% Shenzhen Shandian Jingling Technology Co., Ltd. 37ac13b2-ca55-0e28-e063-6294a90a000e 2025-08-19 Warnings Exact identifier application number: M017 Calamine Plus Pramoxine HCl CALAMINE PLUS SPRAY FSA Store Inc. 3cd18f96-34f7-3f2c-e063-6294a90a3b7e 2025-08-19 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE SPRAY FSA Store Inc. 3ce24b87-55ac-0bbd-e063-6294a90ab582 2025-08-19 Warnings Exact identifier application number: M017 Fast Freeze Pain Relieving MENTHOL, UNSPECIFIED FORM NATURAL ESSENTIALS, INC. 15a26af1-ca5a-40fc-a411-6c0e8ae18fbb 2025-08-18 Warnings Exact identifier application number: M017 Orythia Maximum Strength Lidocaine Pain Relieving LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. 6d6b59f9-f614-4e3c-b07b-32b4591d39f2 2025-08-18 Warnings Exact identifier application number: M017 Ocean Potion Suncare Ice Plus Pain Relieving Soothing LIDOCAINE GNL BRANDS INTERNATIONAL, LLC 3c69654c-cba6-dfef-e063-6394a90ad479 2025-08-15 Warnings Exact identifier application number: M017 Earth Mama Medicated Herbal Lip Balm MENTHOL Eleeo Brands LLC 3c6c16bb-1f4b-b851-e063-6294a90a7404 2025-08-15 Warnings Exact identifier application number: M017 Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Cintas First Aid & Safety 96f17095-31f3-4b8a-ab22-0caaefaa7476 2025-08-15 Warnings Exact identifier application number: M017 MedPride Cold Ice Analgesic Gel MENTHOL SHIELD LINE LLC 860a2c86-b240-4e0e-e053-2a91aa0a333a 2025-08-15 Warnings Exact identifier application number: M017 MedPride Medicated Body Powder Powder MENTHOL, ZINC OXIDE Shield Line LLC cdb2fa5b-cf04-c876-e053-2a95a90a187c 2025-08-15 Warnings Exact identifier application number: M017 Burn LIDOCAINE HART Health c5ff392a-e788-43e0-91ea-5e0f8420586c 2025-08-15 Warnings Exact identifier application number: M017 Stopain Clinical MENTHOL Troy Manufacturing, Inc. 40df30ba-41ba-42b7-93fe-4183b57bdb00 2025-08-14 Warnings Exact identifier application number: M017 Signature Care Aloe Vera Gel with Lidocaine LIDOCAINE Safeway, Inc. d5069622-97b1-ba12-e053-2a95a90a7268 2025-08-14 Warnings Exact identifier application number: M017 METHYL SALICYLATE 25% METHYL SALICYLATE Oncora Pharma, LLC 3c4bc55d-6582-3b5e-e063-6394a90a994c 2025-08-13 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