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 151 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COOL BREEZE Pain Relief	MENTHOL	COOL BREEZE US LLC	14dcf4ee-6778-49d4-8601-9205737432ea	2023-11-01	Warnings	Exact identifier application number: M017
Lidozen	LIDOCAINE HYDROCHLORIDE, MENTHOL	Proficient Rx LP	1ebb45e5-4541-4c95-abe1-661ef763a610	2023-11-01	Warnings	Exact identifier application number: M017
Walgreens Pain Relieving Cream	LIDOCAINE 4%	Walgreens	ce1b55ed-f5c5-ea8b-e053-2a95a90acd40	2023-10-31	Warnings	Exact identifier application number: M017
Walgreens pain relieving	LIDOCAINE 4%	Walgreens	ce2b9e57-749d-715c-e053-2995a90aaf8d	2023-10-31	Warnings	Exact identifier application number: M017
Walgreens Cool n heat	LIDOCAINE 4% MENTHOL 1%	Walgreens	ce168ab7-ec4a-daea-e053-2995a90af829	2023-10-31	Warnings	Exact identifier application number: M017
Methyl Salicylate 40 Percent	METHYL SALICYLATE	Alexso, Inc	53407aab-094c-4393-a2b9-54fd85321e3e	2023-10-31	Warnings	Exact identifier application number: M017
Hydrocortisone Acetate	HYDROCORTISONE ACETATE	Bentlin Products LLC	4346351c-8e11-46ae-b428-98d17f55beb9	2023-10-30	Warnings	Exact identifier application number: M017
Biofreeze Roll-On	MENTHOL	A-S Medication Solutions	814b37ea-5441-4cec-8794-71ca01d849ae	2023-10-30	Warnings	Exact identifier application number: M017
Dr. Sheffield Hydrocortisone Anti itch	HYDROCORTISONE	Sheffield Pharmaceuticals LLC	71c9f2f4-2188-45eb-b55e-3856ac78070b	2023-10-30	Warnings	Exact identifier application number: M017
Family Wellness	BENZOCAINE, RESORCINOL	Zhejiang Jingwei Pharmaceutic Al Co., Ltd.	df540eb8-6773-4647-9cc2-c3fd14d7355e	2023-10-27	Warnings	Exact identifier application number: M017
Family Wellness	HYDROCORTISONE 1%	FRONT PHARMACEUTICAL PLC	ea26265d-f24e-458e-8bf0-287b2d49f4f4	2023-10-27	Warnings	Exact identifier application number: M017
Joint Formula 88 MAX PLUS	CAMPHOR	Sarati International, Inc.	f5d78335-b78d-4909-a88b-9daa3c18ba15	2023-10-27	Warnings	Exact identifier application number: M017
OsmoFlex	MENTHOL	Sarati International, Inc.	479147c0-4cf4-4d7a-8b8e-1a0de49ed73e	2023-10-27	Warnings	Exact identifier application number: M017
Thera plus Anti-itch with aloe Hydrocortisone	HYDROCORTISONE	Fourstar Group USA, Inc.	c69d0670-a65b-1680-e053-2995a90a2ee5	2023-10-26	Warnings	Exact identifier application number: M017
Family Wellness	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	FRONT PHARMACEUTICAL PLC	fde2069b-344e-46da-bb95-c5113e0f35d6	2023-10-26	Warnings	Exact identifier application number: M017
MAXIMUM STRENGTH HEMORRHOIDAL RELIEF	LIDOCAINE	CVS PHARMACY, INC	b61424bf-3b23-420b-a7bc-256ddb96aa22	2023-10-25	Warnings	Exact identifier application number: M017
Assured	HYDROCORTISONE	Zhejiang Jingwei Pharmaceutic Al Co., Ltd.	bc97f364-9443-47b8-9c2d-b5dcc00cc9b7	2023-10-25	Warnings	Exact identifier application number: M017
Stopain Clinical	MENTHOL, UNSPECIFIED FORM	Troy Manufacturing, Inc.	b41091b4-0dc0-4a88-8ff6-11979b3d307a	2023-10-25	Warnings	Exact identifier application number: M017
Thera Plus	HYDROCORTISONE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	bcc99e5a-2403-46da-9c9d-8411fa4104e0	2023-10-25	Warnings	Exact identifier application number: M017
Assured	LIDOCAINE HYDROCHLORIDE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	ab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c	2023-10-25	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