FDA.reportPublic FDA data

ANBESOL MAXIMUM STRENGTH

Product NDC
0573-0225
Requested package NDC
0573-0225-67
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0573-02250573-0225-67DDiscontinued by firm2026-10-15

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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 NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0225-67GM - Gram0573-0225b040a389-cb3d-4510-b81a-1ea41ce6913912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5ANBESOL JR (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) SOLUTION ANBESOL MAXIMUM STRENGTH (BENZOCAINE) GEL [PFIZER CONSUMER HEALTHCARE]3
BENZOCAINEACTIVE MOIETYU3RSY48JW5ANBESOL JR (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) SOLUTION ANBESOL MAXIMUM STRENGTH (BENZOCAINE) GEL [PFIZER CONSUMER HEALTHCARE]3
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9ANBESOL JR (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) SOLUTION ANBESOL MAXIMUM STRENGTH (BENZOCAINE) GEL [PFIZER CONSUMER HEALTHCARE]3
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHANBESOL 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 INGREDIENTHHT01ZNK31ANBESOL 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. 33INACTIVE INGREDIENT9DBA0SBB0LANBESOL 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. 10INACTIVE INGREDIENT35SW5USQ3GANBESOL 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. 1INACTIVE INGREDIENTH3R47K3TBDANBESOL 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. 40INACTIVE INGREDIENTWZB9127XOAANBESOL 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. 6INACTIVE INGREDIENTH77VEI93A8ANBESOL JR (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) SOLUTION ANBESOL MAXIMUM STRENGTH (BENZOCAINE) GEL [PFIZER CONSUMER HEALTHCARE]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TANBESOL JR (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) SOLUTION ANBESOL MAXIMUM STRENGTH (BENZOCAINE) GEL [PFIZER CONSUMER HEALTHCARE]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AANBESOL JR (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) SOLUTION ANBESOL MAXIMUM STRENGTH (BENZOCAINE) GEL [PFIZER CONSUMER HEALTHCARE]3
SACCHARININACTIVE INGREDIENTFST467XS7DANBESOL JR (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) GEL ANBESOL REGULAR STRENGTH (BENZOCAINE) SOLUTION ANBESOL MAXIMUM STRENGTH (BENZOCAINE) GEL [PFIZER CONSUMER HEALTHCARE]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-0225-67005730225671 TUBE in 1 BLISTER PACK (0573-0225-67) > 9 g in 1 TUBE1 tube2005-05-110000-00-00NoNoCurrent