hydrating mouthspray

Manufacturer
Guangzhou Yanxi Biotechnology Co., Ltd
Effective date
2024-11-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:35:27

Label at a glance#

Producthydrating mouthspray
Active ingredientMENTHOL, XYLITOL
Label structure7 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Spray directly into mouth on the tongue.Rub tongue over teeth and gums for at least 5seconds.Use as needed.

WARNINGS SECTION

Keep out of children

INACTIVE INGREDIENT SECTION

Aqua

INDICATIONS & USAGE SECTION

For oral freshness

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of children

OTC - PURPOSE SECTION

Moistens and relieves symptoms of dry mouth

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

84025-25184025-251

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
84025-251-012026-01-29C16284748780-149896155-a944-586f-e063-e6dba90add9026615d91-0187-6c45-e063-6394a90acff0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84025-251-01hydrating mouthspray50 mL in 1 BOTTLELIQUID501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84025-251HYDRATING MOUTHSPRAY LIQUID [GUANGZHOU YANXI BIOTECHNOLOGY CO., LTD]11 package rows20241109_26615d91-0187-6c45-e063-6394a90acff0.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84025-25184025-251-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
XYLITOLVCQ006KQ1EACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
26615d91-0188-6c45-e063-6394a90acff026615d91-0187-6c45-e063-6394a90acff02024-11-08WarningsExact identifier
spl id: 26615d91-0188-6c45-e063-6394a90acff0
spl set id: 26615d91-0187-6c45-e063-6394a90acff0

Reported adverse events (FAERS/openFDA)#

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