Dibucaine

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: Dibucaine
Generic name: DIBUCAINE
Manufacturer: Akron Pharma Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 60469e43-ab6f-46d3-a1df-00e58275f565
SPL ID: da90939a-75f0-4b82-94ff-8611fe746715
Version: 6
Effective date: 2025-01-12
Source export date: 2026-10-12
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:31:24

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 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M015	openfda.application_number
brand name		Dibucaine	openfda.brand_name
generic name		DIBUCAINE	openfda.generic_name
manufacturer name		Akron Pharma Inc.	openfda.manufacturer_name
ndc	package	71399-2829-2	openfda.package_ndc
ndc	package	71399-2829-1	openfda.package_ndc
ndc	product	71399-2829	openfda.product_ndc
ndc11	package	71399282901	derived:openfda.package_ndc
ndc11	package	71399282902	derived:openfda.package_ndc
rxcui		238784	openfda.rxcui
spl id		da90939a-75f0-4b82-94ff-8611fe746715	id
spl set id		60469e43-ab6f-46d3-a1df-00e58275f565	set_id
unii		L6JW2TJG99	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

Warninigs For External Use Only Allergy alert certain persons can develop allergic reactions to ingredients in this product. If the symptoms being treated does not subside or redness, irritation, swelling, bleeding or other symptoms develop or increase, discontinue use and ask a doctor.

Reported adverse events (FAERS/openFDA)#

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