Orajel Antiseptic Rinse For All Mouth Sores

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 Antiseptic Rinse For All Mouth Sores
Generic name: HYDROGEN PEROXIDE AND MENTHOL
Manufacturer: Church & Dwight Co., Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 06188d36-0d60-6ae6-e054-00144ff8d46c
SPL ID: 45c2ec2f-1ee1-84f8-e063-6294a90ae393
Version: 5
Effective date: 2025-12-12
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 05:38:39

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 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M022	openfda.application_number
brand name		Orajel Antiseptic Rinse For All Mouth Sores	openfda.brand_name
generic name		HYDROGEN PEROXIDE AND MENTHOL	openfda.generic_name
manufacturer name		Church & Dwight Co., Inc.	openfda.manufacturer_name
ndc	package	10237-760-48	openfda.package_ndc
ndc	package	10237-760-16	openfda.package_ndc
ndc	product	10237-760	openfda.product_ndc
ndc11	package	10237076048	derived:openfda.package_ndc
ndc11	package	10237076016	derived:openfda.package_ndc
rxcui		2584344	openfda.rxcui
spl id		45c2ec2f-1ee1-84f8-e063-6294a90ae393	id
spl set id		06188d36-0d60-6ae6-e054-00144ff8d46c	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

When using this product do not swallow do not exceed recommended dosage Do not use this product for more than 7 days unless directed by a dentist or healthcare provider Stop use and see your physician promptly if swallowing, 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.