Americaine

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: Americaine
Generic name: BENZOCAINE
Manufacturer: Insight Pharmaceuticals LLC
Product type: HUMAN OTC DRUG
SPL set ID: d13c022f-2f91-40b4-bd66-0cfc0e147a5f
SPL ID: 41746b33-0ff3-4b02-8018-34e4fd54ef7b
Version: 6
Effective date: 2025-10-23
Source export date: 2026-09-28
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:34:27

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		M015	openfda.application_number
brand name		Americaine	openfda.brand_name
generic name		BENZOCAINE	openfda.generic_name
manufacturer name		Insight Pharmaceuticals LLC	openfda.manufacturer_name
ndc	package	63736-375-01	openfda.package_ndc
ndc	product	63736-375	openfda.product_ndc
ndc11	package	63736037501	derived:openfda.package_ndc
rxcui		1426293	openfda.rxcui
rxcui		244557	openfda.rxcui
spl id		41746b33-0ff3-4b02-8018-34e4fd54ef7b	id
spl set id		d13c022f-2f91-40b4-bd66-0cfc0e147a5f	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 For external use only . When using this product certain persons can develop allergic reactions to ingredients in this product do not put this product into the rectum by using fingers or any mechanical device or applicator do not exceed dosage unless directed by a doctor Stop use and ask a doctor if condition worsens or does not improve in 7 days bleeding occurs symptoms do not get better, or if redness, irritation, swelling, pain or other symptoms occur or increase Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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