Oral Pain Relief

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: Oral Pain Relief
Generic name: BENZOCAINE AND BENZALKONIUM CHLORIDE
Manufacturer: Universal Distribution Center LLC
Product type: HUMAN OTC DRUG
SPL set ID: 18520f9b-4d35-1e9c-e063-6294a90aaa39
SPL ID: 28d09e8b-190f-40da-ab8a-9bd2d41ae419
Version: 3
Effective date: 2025-10-30
Source export date: 2026-09-28
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:07:21

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		Oral Pain Relief	openfda.brand_name
generic name		BENZOCAINE AND BENZALKONIUM CHLORIDE	openfda.generic_name
manufacturer name		Universal Distribution Center LLC	openfda.manufacturer_name
ndc	package	52000-060-02	openfda.package_ndc
ndc	product	52000-060	openfda.product_ndc
ndc11	package	52000006002	derived:openfda.package_ndc
rxcui		1595155	openfda.rxcui
spl id		28d09e8b-190f-40da-ab8a-9bd2d41ae419	id
spl set id		18520f9b-4d35-1e9c-e063-6294a90aaa39	set_id
unii		U3RSY48JW5	openfda.unii
unii		F5UM2KM3W7	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 Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduce the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: pale, gray, or blue colored skin (cyanosis) • headache • rapid heart rate • shortness of breath • dizziness or lightheadness • fatigue or lack of energy Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine or other "caine" anesthetics

Reported adverse events (FAERS/openFDA)#

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