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 104 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Capsaicin 0.025% Cream CAPSAICIN 0.025% Puretek Corporation 28f00df0-c416-f17b-e063-6294a90a5570 2025-01-02 Warnings Exact identifier application number: M017 AVON HeXashield Pain Relief for Muscle, Back and Joint Cream CAMPHOR, MENTHOL, METHYL SALICYLATE Tai Guk Pharm. Co., Ltd. 8f29ffd7-48b9-109f-e053-2995a90ab215 2025-01-01 Warnings Exact identifier application number: M017 AVON HeXashield Arthritis Pain Relief Cream Capsaisin CAPSAISIN Tai Guk Pharm. Co., Ltd. 8f286a9d-8765-21b3-e053-2a95a90ae43a 2025-01-01 Warnings Exact identifier application number: M017 AVON HeXashield Anti Itch Cream with Healing Aloe HYDROCORTISONE Tai Guk Pharm. Co., Ltd. 8f2aa11d-d794-6f3e-e053-2995a90a1d9d 2025-01-01 Warnings Exact identifier application number: M017 HeXashield Anti Itch Cream with Healing Aloe HYDROCORTISONE Tai Guk Pharm. Co., Ltd. b9d033f3-4d12-a2c8-e053-2995a90ac7f1 2025-01-01 Warnings Exact identifier application number: M017 Green Compass Reduce Pain Relief with Menthol MENTHOL Green Compass, Inc. 0a0c212e-ae5d-8505-e063-6394a90af622 2025-01-01 Warnings Exact identifier application number: M017 Green Compass Reduce Pain Relief CAMPHOR, MENTHOL, METHYL SALICYLATE Green Compass, Inc. 0a0b688e-50f1-3eb1-e063-6394a90a7efa 2025-01-01 Warnings Exact identifier application number: M017 Green Compass Reduce Topical Pain CAMPHOR, MENTHOL, METHYL SALICYLATE Green Compass, Inc. 8cb80362-5d24-1ee3-e053-2a95a90afcdf 2025-01-01 Warnings Exact identifier application number: M017 OKeeffes Working Hands Pain Relief Skin Protectant ALLANTOIN, LIDOCAINE HYDROCHLORIDE The Gorilla Glue Company/O'Keeffe's Company 0685da25-c9fa-e1cd-e063-6394a90ae1b3 2025-01-01 Warnings Exact identifier application number: M017 Icy Hot with Lidocaine Pain Relieving LIDOCAINE HCL AND MENTHOL Chattem, Inc. 75b28b06-77ea-4fea-b516-2e8a0dac7037 2025-01-01 Warnings Exact identifier application number: M017 Advanced Seal Barrier plus Pain Relief LIDOCAINE Kericure Inc. 7ac95325-e6e9-4c56-9315-876c00af7c98 2025-01-01 Warnings Exact identifier application number: M017 FixMySkin Healing Balm Fragrance-Free HYDROCORTISONE Lovely Skin, Inc. c12af4c6-2f05-46ec-b901-1a4fcd750180 2024-12-31 Warnings Exact identifier application number: M017 Pain Relieving Cream Lidocaine BENZYL ALCOHOL, LIDOCAINE HCI Trifecta Pharmaceuticals USA LLC 039a2036-54b2-cf28-e063-6294a90a8ce6 2024-12-31 Warnings Exact identifier application number: M017 Cold Therapy Pain Relief Walgreens MENTHOL 10.5% WALGREEN COMPANY f1daa68d-1b12-c28a-e053-2995a90a0949 2024-12-31 Warnings Exact identifier application number: M017 Calypxo Pain Relief METHYL SALICYLATE, MENTHOL Advanced Rx of Tennessee, LLC 0b7736df-c7e0-7d00-e063-6294a90aa57e 2024-12-31 Warnings Exact identifier application number: M017 New Terocin METHYL SALICYLATE, CAPSAICIN, AND MENTHOL Advanced Rx Pharmacy of Tennessee, LLC f4bfc4a6-06ef-1f76-e053-2995a90a2b8f 2024-12-31 Warnings Exact identifier application number: M017 Lidocaine LIDOCAINE Advanced Rx Pharmacy of Tennessee, LLC 01cb19a4-ce22-144d-e063-6294a90a8aa3 2024-12-31 Warnings Exact identifier application number: M017 Satohap Lidocaine 4% Menthol 1% Pain Relieving Cream LIDOCAINE, MENTHOL Sato Pharmaceutical Co., Ltd. 2251e96b-d050-4ec2-a6b9-6659610885bf 2024-12-30 Warnings Exact identifier application number: M017 hydrocortisone HYDROCORTISONE Safeway af2e2ef3-0f3f-4592-8081-b6553ade2f5a 2024-12-26 Warnings Exact identifier application number: M017 Comforte Menstrual Cramp Relief Cream MENTHOL PMS4PMS LLC c121537e-3333-4f35-8c77-20086158dff4 2024-12-26 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