Forticept Wounds and Burns Hydrogel

Product NDC: 72127-0803
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 · 21 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	72127-0803-0	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	72127-0803-1	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	72127-0803-0	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	72127-0803-1	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	72127-0803-0	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	72127-0803-1	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	72127-0803-0	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	72127-0803-1	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	72127-0803-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	72127-0803-0	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	72127-0803-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72127-0803-0	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	72127-0803-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72127-0803-0	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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c6f58b63-9838-4ff4-8b1a-de2d41d6cf5f	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
72127-0803-0	2025-03-25	Forticept Wounds and Burns Hydrogel
72127-0803-1	2025-03-25	Forticept Wounds and Burns Hydrogel
72127-0803-0	2025-01-30	Forticept Wounds and Burns Hydrogel
72127-0803-1	2025-01-30	Forticept Wounds and Burns Hydrogel

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 144 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IceQuake Analgestic White	METHYL SALICYLATE, MENTHOL	Southern Sales & Service, Inc.	54e5dcd5-9987-488d-a758-d0e76d155182	2023-11-29	Warnings	Exact identifier application number: M017
Icequake Coldn Hot medicated patch	MENTHOL	Southern Sales & Service, Inc.	89202c52-9eb7-4e5a-a709-4a66ab0d3a72	2023-11-29	Warnings	Exact identifier application number: M017
IceQuake Lidocaine Analgesic	LIDOCAINE HYDROCHLORIDE	Southern Sales & Service, Inc.	9089cb78-e9f8-4437-a767-df809a114c4b	2023-11-29	Warnings	Exact identifier application number: M017
Ice Quake Muscle Rub Blue	MENTHOL	Southern Sales & Service, Inc.	5180f6a3-58f1-4c50-a33b-7d85a3c1b99b	2023-11-29	Warnings	Exact identifier application number: M017
Discount Drug Mart Extra Strength Itch Stopping	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Discount Drug Mart	8579df23-ac07-9df8-e053-2991aa0a8bbb	2023-11-29	Warnings	Exact identifier application number: M017
Satohap	METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL	Sato Pharmaceutical Co., Ltd.	3a2fc8ae-f1ac-4c64-8e75-d5fdb141aecf	2023-11-28	Warnings	Exact identifier application number: M017
Poli-A	HYDROCORTISONE ACETATE	Sato Pharmaceutical Co., Ltd.	e27a3840-d9de-4bd0-ad75-8a151bd12b83	2023-11-28	Warnings	Exact identifier application number: M017
Sheffield Arthritis and Muscle Pain Relief	CAPSICUM OLEORESIN	Sheffield Pharmaceuticals LLC	724b9870-e86a-4087-ba78-8c944ce3baa6	2023-11-28	Warnings	Exact identifier application number: M017
Dr Sheffield Muscle Rub Cream	MUSCLE RUB CREAM	Sheffield Pharmaceuticals LLC	60d1d826-a53e-42e5-bc30-1b2c2690445b	2023-11-28	Warnings	Exact identifier application number: M017
Thera Plus Cold Therapy Pain Relieving Menthol	MENTHOL	Fourstar Group USA, Inc.	0a462c91-5300-e282-e063-6394a90a4cc2	2023-11-27	Warnings	Exact identifier application number: M017
UtaSpray	MENTHOL AND METHYL SALICYLATE	Big 5 Nutrition LLC	c641ab11-cd00-4e23-ace7-8178739084f0	2023-11-21	Warnings	Exact identifier application number: M017
Top Medicated Oil	CAMPHOR, MENTHOL, METHYL SALICYLATE	Big 5 Nutrition LLC	b2f0d1e1-7d03-434e-be39-9f980459690c	2023-11-21	Warnings	Exact identifier application number: M017
BT Pain Relief Balm	METHYL SALICYLATE, MENTHOL, CAMPHOR	Big 5 Nutrition LLC	50112419-c934-4d3a-9ea6-9b089f516a6d	2023-11-21	Warnings	Exact identifier application number: M017
BT Pain Relief	MENTHOL, METHYL SALICYLATE	Big 5 Nutrition LLC	91324910-27cf-424f-9e9b-6173f2d7acbf	2023-11-21	Warnings	Exact identifier application number: M017
Dit Da Shui	MENTHOL AND METHYL SALICYLATE	Big 5 Nutrition LLC	5d45cb48-3e88-4d58-81d2-6f88d7a82134	2023-11-20	Warnings	Exact identifier application number: M017
Herbal Balm	METHYL SALICYLATE, MENTHOL AND	Big 5 Nutrition LLC	09b3b86d-3434-428b-b0a8-e8dfd7c0b52a	2023-11-20	Warnings	Exact identifier application number: M017
Hydrocortisone	ANTIPRURITIC (ANTI-ITCH)	BluePoint Laboratories	b505769e-9c46-3cf3-e053-2a95a90a4df9	2023-11-17	Warnings	Exact identifier application number: M017
Hydrocortisone	ANTIPRURITIC (ANTI-ITCH)	BluePoint Laboratories	d6523993-d781-cdbc-e053-2a95a90af191	2023-11-17	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE PRO FORMULA	MENTHOL, UNSPECIFIED FORM	KOBAYASHI Healthcare International, Inc.	4d91baf3-9655-4786-93b8-aa0d93fe0bf9	2023-11-16	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE LEG CRAMP	MENTHOL	KOBAYASHI Healthcare International, Inc.	7ef03298-6623-4cf4-b21f-74b2ffc11c6e	2023-11-16	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
PH41D05744	BENZETHONIUM CHLORIDE	121-54-0	BENZETHONIUM CHLORIDE
98PI200987	LIDOCAINE	137-58-6	LIDOCAINE

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
72127-0803-1	72127080301	.085 kg in 1 TUBE (72127-0803-1)	2021-02-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Forticept Wounds and Burns Hydrogel	Lidan, inc. \| Cosco International, Inc.	2025-03-25	HUMAN OTC DRUG LABEL	5