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 76 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methyl Salicylate	METHYL SALICYLATE	PHARMACURE LLC	66b13044-69d2-4559-9e65-8a4c601c077a	2025-10-06	Warnings	Exact identifier application number: M017
Methyl Salicylate	METHYL SALICYLATE	PHARMACURE LLC	f119a1bd-095f-41f5-86d5-c0ee4f19fd2c	2025-10-06	Warnings	Exact identifier application number: M017
LIDOCAINE	LIDOCAINE	PHARMACURE LLC	31d5e5c9-6ec4-4496-8a4c-cca39a2cbe32	2025-10-06	Warnings	Exact identifier application number: M017
Tempo cool	MENTHOL	The Egyptian Saudi Co. For Medical Manufacturing (Masco-Mid) S.A.E	bd642389-6d03-4e09-a71c-312fb90eae89	2025-10-06	Warnings	Exact identifier application number: M017
Menthopatch Hot	MENTHOL , CAPSICUM EXTRACT	THE EGYPTIAN SAUDI CO FOR MEDICAL MANUFACTURING MASCOMID	3d289be3-c237-4065-a8ac-e8c2e51b76a5	2025-10-06	Warnings	Exact identifier application number: M017
Mentho patch cool	MENTHOL	THE EGYPTIAN SAUDI CO FOR MEDICAL MANUFACTURING MASCOMID	02251a4a-fc6f-42c9-a244-6f4835de5edd	2025-10-06	Warnings	Exact identifier application number: M017
Feminine Anti-Itch Creme	BENZOCAINE, RESORCINOL	Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)	aa6cc963-dc60-5222-e053-2995a90acaf6	2025-10-06	Warnings	Exact identifier application number: M017
TheraCare 2% Diphenhydramine Anti-Itch Cream	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Veridian Healthcare	5999b677-63dd-49c6-b5b8-7b3c117ecc5c	2025-10-06	Warnings	Exact identifier application number: M017
HealthWise Pain Relief	MENTHOL	Veridian Healthcare	06be5331-7a1e-4ab3-9f17-2d350bd4b890	2025-10-02	Warnings	Exact identifier application number: M017
equate Burn Relief	LIDOCAINE HYDROCHLORIDE	Walmart Inc	a90cbd92-80a5-4463-8152-b83165121a6f	2025-10-02	Warnings	Exact identifier application number: M017
AsperFlex HOT	CAMPHOR, MENTHOL, METHYL SALICYLATE	Akron Pharma Inc.	a6cb0656-8866-44ff-b40c-73655ff68721	2025-10-02	Warnings	Exact identifier application number: M017
AsperFlex Original Maximum Strength	MENTHOL	Akron Pharma Inc.	d766c61e-c48b-4aff-97b0-678159479e03	2025-10-02	Warnings	Exact identifier application number: M017
HealthWise Feminine Anti-Itch Cream	BENZOCAINE, RESORCINOL	Veridian Healthcare	1f9110da-f448-8e20-e063-6294a90a4275	2025-10-02	Warnings	Exact identifier application number: M017
PROSTAT FIRST AID Burn Ease, 0.9g	LIDOCAINE	ProStat First Aid LLC	dc704403-e2aa-47f7-a7f4-f6afe1547ca8	2025-10-01	Warnings	Exact identifier application number: M017
PROSTAT FIRST AID Burn Ease, 0.9g	LIDOCAINE	ProStat First Aid LLC	e02558a9-fe2b-4f28-9fd3-7308f859d759	2025-10-01	Warnings	Exact identifier application number: M017
FL Burn Ease, 0.9g	LIDOCAINE	ProStat First Aid LLC	4dc0d579-ab42-4ea5-9788-5e54d7d318a3	2025-10-01	Warnings	Exact identifier application number: M017
Carmex Classic Lip Balm Medicated	CAMPHOR (SYNTHETIC), WHITE PETROLATUM	Carma Laboratories, Inc.	c7a7626c-cf82-4301-af79-c5e85367e777	2025-10-01	Warnings	Exact identifier application number: M017
Viaderma Calm Anti-Itch	HYDROCORTISONE	ViaDerma Distribution, Inc.	7afa2ccd-bfc6-48fc-9a14-a0c6d645844e	2025-10-01	Warnings	Exact identifier application number: M017
AsperFlex Advance	CAMPHOR, MENTHOL, METHYL SALICYLATE	Akron Pharma Inc.	d23d7f2b-4dcd-4c31-9d12-340f233018b4	2025-10-01	Warnings	Exact identifier application number: M017
HEATING PAIN RELIEF	METHYL SALICYLATE, MENTHOL	SUNSET NOVELTIES, INC	4024d604-c8c7-2d73-e063-6294a90a2e80	2025-10-01	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