Orajel 2x Gum Pain Alcohol-Free

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 2x Gum Pain Alcohol-Free
Generic name: MENTHOL AND HYDROGEN PEROXIDE
Manufacturer: Church & Dwight Co., Inc.
Product type: HUMAN OTC DRUG
SPL set ID: adf37010-922c-4441-93d6-1e1a95025e90
SPL ID: 27eb6e9e-5cd7-d08a-e063-6394a90ad5b6
Version: 2
Effective date: 2024-11-27
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:27:10

Harmonized routes table
Harmonized routes
ORAL

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		Orajel 2x Gum Pain Alcohol-Free	openfda.brand_name
generic name		MENTHOL AND HYDROGEN PEROXIDE	openfda.generic_name
manufacturer name		Church & Dwight Co., Inc.	openfda.manufacturer_name
ndc	package	10237-799-16	openfda.package_ndc
ndc	product	10237-799	openfda.product_ndc
ndc11	package	10237079916	derived:openfda.package_ndc
rxcui		2584344	openfda.rxcui
spl id		27eb6e9e-5cd7-d08a-e063-6394a90ad5b6	id
spl set id		adf37010-922c-4441-93d6-1e1a95025e90	set_id
unii		L7T10EIP3A	openfda.unii
unii		BBX060AN9V	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 Do not use this product for more than 7 days unless directed by a dentist or healthcare provider When using this product do not swallow do not exceed recommended dosage Stop use and see your physician promptly if swelling, rash or fever develops irritation, pain or redness persists or worsens sore mouth symptoms do not improve in 7 days Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Reported adverse events (FAERS/openFDA)#

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