Home NDC 72127-0803-0 Forticept Wounds and Burns Hydrogel
Product NDC 72127-0803
Requested package NDC 72127-0803-0
11-digit product format 721270803
Labeler code 72127
Product ID 72127-0803_3b775197-f88c-4e50-a12d-c44925706e8b
Type HUMAN OTC DRUG
Nonproprietary name BENZETHONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
Dosage form GEL
Route TOPICAL
Labeler Lidan, inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-05-06
Substance BENZETHONIUM CHLORIDE; LIDOCAINE
Active strength .001; .04 kg/kg; kg/kg
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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 · 7 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 2025-04-01 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 Forticept Wounds and Burns Hydrogel
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZETHONIUM CHLORIDE .001 kg/kg LIDOCAINE .04 kg/kg
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination PH41D05744 Internal UNII lookup 98PI200987 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72127-0803-0 Forticept Wounds and Burns Hydrogel 0.114 kg in 1 TUBE GEL 0.114 5 72127-0803-1 Forticept Wounds and Burns Hydrogel 0.085 kg in 1 TUBE GEL 0.085 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72127-0803 FORTICEPT WOUNDS AND BURNS HYDROGEL (BENZETHONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) GEL [LIDAN, INC.] 5 Current NDC, Legacy NDC, 2 package rows 20250327_c6f58b63-9838-4ff4-8b1a-de2d41d6cf5f.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 133 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dermachange Cold Therapy MENTHOL Private Label Beauty and Wellness 12ef7dd8-3da3-9c87-e063-6394a90ac924 2024-03-05 Warnings Exact identifier application number: M017 Dermachange Arthritis Relief TROLAMIN SALICYLATE Private Beauty Label and Wellness 12dbfa50-1b97-f988-e063-6394a90a662c 2024-03-04 Warnings Exact identifier application number: M017 Analgesic MENTHOL Safetec of America, Inc. b0f4010c-995f-40e1-aa40-92760e697a61 2024-03-02 Warnings Exact identifier application number: M017 Icy Hot Advanced Relief CAMPHOR AND MENTHOL Chattem, Inc. 9979ff36-415b-44e4-bb10-6bf682cd00f9 2024-03-01 Warnings Exact identifier application number: M017 Amish Origins Pain Relieving Menthol 8% MENTHOL Amish Origins Management, LLC 5051b650-18a4-481e-a8d7-d41d4ae51efd 2024-02-29 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE TRIFECTA PHARMACEUTICALS USA LLC 2999fecb-cb15-4023-ade4-ab5822b094d5 2024-02-29 Warnings Exact identifier application number: M017 Amish Origins Pain Relieving Menthol 8 MENTHOL Amish Origins Management, LLC aaad56d5-6737-4edc-af0e-8e207695c0ec 2024-02-29 Warnings Exact identifier application number: M017 Amish Origins Pain Relieving Menthol 8% MENTHOL Amish Origins Management, LLC b120404f-5a07-4182-bb50-d943418622da 2024-02-29 Warnings Exact identifier application number: M017 Amish Origins Topical Analgesic Camphor 2% CAMPHOR (SYNTHETIC) Amish Origins Management, LLC 437491ca-60ff-4508-b408-f97e7152f638 2024-02-29 Warnings Exact identifier application number: M017 Amish Origins Topical Analgesic Camphor 2% CAMPHOR (SYNTHETIC) Amish Origins Management, LLC ffe15aed-ea90-4db8-aace-d691a81c05ae 2024-02-29 Warnings Exact identifier application number: M017 LidoPro Patch LIDOCAINE, MENTHOL, AND METHYL SALICYLATE Advanced Rx Pharmacy of Tennessee, LLC 128d0ba9-bc9d-af16-e063-6394a90af5ef 2024-02-29 Warnings Exact identifier application number: M017 Leader Roll-On Cooling Pain Relief Topical Analgesic MENTHOL, UNSPECIFIED FORM Cardinal Health, 110 dba LEADER e86cba40-6b10-454d-98b3-6b547456eaad 2024-02-29 Warnings Exact identifier application number: M017 Maximum Strength Scalp Itch Relief Anti-itch HYDROCORTISONE Rite Aid 55569563-fc38-4f97-8e74-9f96e3173384 2024-02-28 Warnings Exact identifier application number: M017 Walgreens Eczema Relief HYDROCORTISONE ACETATE Walgreen Co. 4a65a1bf-aa24-4452-9ec3-a28c8bf0e47c 2024-02-28 Warnings Exact identifier application number: M017 meijer Cold Therapy Pain Relieving analgesic MENTHOL, UNSPECIFIED FORM Meijer Distribution, Inc fb163112-d84d-418d-a410-3214c0ee4b5a 2024-02-28 Warnings Exact identifier application number: M017 SunBurnt PLUS LIDOCAINE HYDROCHLORIDE Quest Products, LLC. 12128c75-015d-8a72-e063-6394a90ae00a 2024-02-23 Warnings Exact identifier application number: M017 Kroger Analgesic Analgesic LIDOCAINE HYDROCHLORIDE THE KROGER CO e6c5ead3-87d0-48ed-a4dc-86cf89ebb285 2024-02-22 Warnings Exact identifier application number: M017 Rugby Pain Relieving Analgesic MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE Bryant Ranch Prepack fcf48536-224e-4a3d-9124-770031823972 2024-02-22 Warnings Exact identifier application number: M017 meijer ROLL-ON Cold Therapy Pain Relieving Topical analgesic MENTHOL, UNSPECIFIED FORM Meijer Distribution, Inc 8bc3956b-b82d-4ed3-8bc3-db0078466bbc 2024-02-22 Warnings Exact identifier application number: M017 Promescent Delay Wipes BENZOCAINE Absorption f0a5b6be-acc5-473c-9054-b9534e769db1 2024-02-20 Warnings Exact identifier application number: M017
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 72127-0803-0 72127080300 .114 kg in 1 TUBE (72127-0803-0) 2020-05-06 0000-00-00 No No Current