ANBESOL MAXIMUM STRENGTH

Product NDC: 0573-0225
11-digit product format: 005730225
Labeler code: 0573
Product ID: 0573-0225_0fcbe2f9-1b05-47f9-b8c7-47f9c34bfb82
Type: HUMAN OTC DRUG
Nonproprietary name: benzocaine
Dosage form: GEL
Route: TOPICAL
Labeler: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Application: part356
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2005-05-11
Marketing end: 0000-00-00
Substance: BENZOCAINE
Active strength: 200 mg/g
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0573-0225		D	Discontinued by firm	2026-10-15
excluded package	package	0573-0225	0573-0225-01	D	Discontinued by firm	2026-10-15
excluded package	package	0573-0225	0573-0225-67	D	Discontinued by firm	2026-10-15

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 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0573-0225-67	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0573-0225-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0573-0225-67	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0573-0225-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0573-0225-67	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0573-0225-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0573-0225-67	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0573-0225-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0573-0225-67	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0573-0225-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0573-0225-67	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0573-0225-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0573-0225-67	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0573-0225-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0573-0225-67	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0573-0225-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0573-0225-67	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0573-0225-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0573-0225-67	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0573-0225-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0573-0225-67	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0573-0225-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0573-0225-67	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0573-0225-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0573-0225-67	GM - Gram	0573-0225	b040a389-cb3d-4510-b81a-1ea41ce69139	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZOCAINE	ACTIVE INGREDIENT	U3RSY48JW5	ANBESOL JR (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) SOLUTION ANBESOL MAXIMUM STRENGTH (BENZOCAINE) GEL [PFIZER CONSUMER HEALTHCARE]	3
BENZOCAINE	ACTIVE MOIETY	U3RSY48JW5	ANBESOL JR (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) SOLUTION ANBESOL MAXIMUM STRENGTH (BENZOCAINE) GEL [PFIZER CONSUMER HEALTHCARE]	3
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	ANBESOL JR (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) SOLUTION ANBESOL MAXIMUM STRENGTH (BENZOCAINE) GEL [PFIZER CONSUMER HEALTHCARE]	3
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	ANBESOL JR (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) SOLUTION ANBESOL MAXIMUM STRENGTH (BENZOCAINE) GEL [PFIZER CONSUMER HEALTHCARE]	3
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	HHT01ZNK31	ANBESOL JR (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) SOLUTION ANBESOL MAXIMUM STRENGTH (BENZOCAINE) GEL [PFIZER CONSUMER HEALTHCARE]	3
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	ANBESOL JR (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) SOLUTION ANBESOL MAXIMUM STRENGTH (BENZOCAINE) GEL [PFIZER CONSUMER HEALTHCARE]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ANBESOL JR (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) SOLUTION ANBESOL MAXIMUM STRENGTH (BENZOCAINE) GEL [PFIZER CONSUMER HEALTHCARE]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ANBESOL JR (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) SOLUTION ANBESOL MAXIMUM STRENGTH (BENZOCAINE) GEL [PFIZER CONSUMER HEALTHCARE]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ANBESOL JR (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) SOLUTION ANBESOL MAXIMUM STRENGTH (BENZOCAINE) GEL [PFIZER CONSUMER HEALTHCARE]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ANBESOL JR (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) SOLUTION ANBESOL MAXIMUM STRENGTH (BENZOCAINE) GEL [PFIZER CONSUMER HEALTHCARE]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ANBESOL JR (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) SOLUTION ANBESOL MAXIMUM STRENGTH (BENZOCAINE) GEL [PFIZER CONSUMER HEALTHCARE]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ANBESOL JR (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) SOLUTION ANBESOL MAXIMUM STRENGTH (BENZOCAINE) GEL [PFIZER CONSUMER HEALTHCARE]	3
SACCHARIN	INACTIVE INGREDIENT	FST467XS7D	ANBESOL JR (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) SOLUTION ANBESOL MAXIMUM STRENGTH (BENZOCAINE) GEL [PFIZER CONSUMER HEALTHCARE]	3

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3RSY48JW5	BENZOCAINE	94-09-7	BENZOCAINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0573-0225-67	00573022567	1 TUBE in 1 BLISTER PACK (0573-0225-67) > 9 g in 1 TUBE	1 tube	2005-05-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	2022-01-05	HUMAN OTC DRUG LABEL	7