Orajel 4X Medicated PM For Toothache and Gum

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: Orajel 4X Medicated PM For Toothache and Gum
Generic name: BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE
Manufacturer: Church & Dwight Co., Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 999cff2b-c23e-5abe-e053-2a95a90a7569
SPL ID: 45c30015-1521-2ab6-e063-6294a90ac193
Version: 9
Effective date: 2025-12-12
Source export date: 2026-10-12
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:45:48

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 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M022	openfda.application_number
brand name		Orajel 4X Medicated PM For Toothache and Gum	openfda.brand_name
generic name		BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	openfda.generic_name
manufacturer name		Church & Dwight Co., Inc.	openfda.manufacturer_name
ndc	package	10237-789-25	openfda.package_ndc
ndc	product	10237-789	openfda.product_ndc
ndc11	package	10237078925	derived:openfda.package_ndc
rxcui		2370903	openfda.rxcui
spl id		45c30015-1521-2ab6-e063-6294a90ac193	id
spl set id		999cff2b-c23e-5abe-e053-2a95a90a7569	set_id
unii		U3RSY48JW5	openfda.unii
unii		L7T10EIP3A	openfda.unii
unii		F5UM2KM3W7	openfda.unii
unii		86Q357L16B	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 reduces 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 lightheadedness, 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, benzocaine or other "caine" anesthetics

Reported adverse events (FAERS/openFDA)#

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