Zilactin-B

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: Zilactin-B
Generic name: BENZOCAINE
Manufacturer: ASCENT CONSUMER PRODUCTS, INC
Product type: HUMAN OTC DRUG
SPL set ID: 42eeb3d4-bac6-4e29-e063-6294a90a644d
SPL ID: 42eec176-84ad-1e81-e063-6394a90afd01
Version: 1
Effective date: 2025-11-06
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 05:54:42

Harmonized routes table
Harmonized routes
TOPICAL

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M022	openfda.application_number
brand name		Zilactin-B	openfda.brand_name
generic name		BENZOCAINE	openfda.generic_name
manufacturer name		ASCENT CONSUMER PRODUCTS, INC	openfda.manufacturer_name
ndc	package	42829-550-32	openfda.package_ndc
ndc	product	42829-550	openfda.product_ndc
ndc11	package	42829055032	derived:openfda.package_ndc
rxcui		198488	openfda.rxcui
rxcui		1542803	openfda.rxcui
spl id		42eec176-84ad-1e81-e063-6394a90afd01	id
spl set id		42eeb3d4-bac6-4e29-e063-6294a90a644d	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 Flammable: keep away from fire or flame 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 Stop use and ask a physician if sore mouth symptoms do not improve in 7 days swelling, rash or fever develops irritation, pain or redness persists or worsens apply only to affected area do not exceed recommended dosage avoid contact with the eyes do not use for more than 7 days unless directed by a physician or dentist Keep out of reach of children . If swallowed, get medical help or contact a poison control center immediately.

Reported adverse events (FAERS/openFDA)#

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