Topcare Maximum Strength

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Topcare Maximum Strength
Generic name: BENZOCAINE
Manufacturer: Topco Associates LLC
Product type: HUMAN OTC DRUG
SPL set ID: 6586fcda-b232-46b4-8461-c0042a4127c6
SPL ID: 3c30a984-220e-ed07-e063-6394a90ae4d7
Version: 14
Effective date: 2025-08-12
Source export date: 2026-09-28
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:54:18

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M022	openfda.application_number
brand name		Topcare Maximum Strength	openfda.brand_name
generic name		BENZOCAINE	openfda.generic_name
manufacturer name		Topco Associates LLC	openfda.manufacturer_name
ndc	package	36800-443-58	openfda.package_ndc
ndc	product	36800-443	openfda.product_ndc
ndc11	package	36800044358	derived:openfda.package_ndc
rxcui		308657	openfda.rxcui
spl id		3c30a984-220e-ed07-e063-6394a90ae4d7	id
spl set id		6586fcda-b232-46b4-8461-c0042a4127c6	set_id
unii		U3RSY48JW5	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Allergy Alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics When using this product avoid contact with eyes do not exceed recommended dosage do not use for more than 7 days unless directed by a dentist or doctor Stop use and ask doctor or dentist if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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