Mouthwash

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: Mouthwash
Generic name: MENTHOL, METHYL SALICYLATE, THYMOL
Manufacturer: Orazen Inc
Product type: HUMAN OTC DRUG
SPL set ID: 873c43df-1d46-359b-e053-2a91aa0a4319
SPL ID: 323a2253-01b0-de24-e063-6394a90ae0d7
Version: 2
Effective date: 2025-04-07
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 05:26:31

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		Mouthwash	openfda.brand_name
generic name		MENTHOL, METHYL SALICYLATE, THYMOL	openfda.generic_name
manufacturer name		Orazen Inc	openfda.manufacturer_name
ndc	package	71927-006-01	openfda.package_ndc
ndc	product	71927-006	openfda.product_ndc
ndc11	package	71927000601	derived:openfda.package_ndc
rxcui		1043619	openfda.rxcui
spl id		323a2253-01b0-de24-e063-6394a90ae0d7	id
spl set id		873c43df-1d46-359b-e053-2a91aa0a4319	set_id
unii		3J50XA376E	openfda.unii
unii		L7T10EIP3A	openfda.unii
unii		RV6J6604TK	openfda.unii
unii		LAV5U5022Y	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 Stop use and see your dentist immediately if gingivitis, bleeding or redness persists for more than 2 weeks you have painful or swollen gums, pus from the gum line, loose teeth, or increasing space between the teeth These may be signs or symptoms of periodontitis, a serious form of gum disease.

Reported adverse events (FAERS/openFDA)#

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