FDA.reportPublic FDA data

White-Glo whiting tooth

Manufacturer
HUAIAN ZONGHENG BIO-TECH CO., LTD
Effective date
2018-02-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:21

Label at a glance#

ProductWhite-Glo whiting tooth
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure8 sections

Dosage and administration

Adults and children 6 years of age and older:brush teeth thoroughly, after meals or at least twice a day or use as directed by a dentist. do not swallow to minimize swallowing use a pea-sized amount in children under 6 supervise children's burshing ntil good habits are established children under 2 years ask a dentist

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

sodium monofluorphosphate  0.76%

Purpose

OTC - PURPOSE SECTION

Anticavitytoothpaste

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warning

WARNINGS SECTION

Keep out of reach of children under 6 years of age.

If more than used for brushing is accidently swallowed get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years of age and older:brush teeth thoroughly, after meals or at least twice a day or use as directed by a dentist.

do not swallow

to minimize swallowing use a pea-sized amount in children under 6

supervise children's burshing ntil good habits are established

children under 2 years ask a dentist

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Calcium Carbonate,Aqua,Glycerin,Sorbitol,Silica,Aroma,Sodium Lauryl Sulphate,Carboxymethyl Hydroxyethyl cellulose,Chondrus Crispus,CI77891(Titanium Dioxide),Sodium saccharin,rose canina fruit oil

Keep out of reach of children under 6 years of age

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

00

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN1
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138792260008552GTIN-13: 8792260008552
EAN-13: 8792260008552
GTIN storage (14 digits): 08792260008552		20180202144522.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71167-004-012020-01-31C16284748780-19d75b9d0-9568-f424-e053-dadaa90a57ce71167-004
71167-004-022020-01-31C16284748780-19d75b9d0-9568-f424-e053-dadaa90a57ce71167-004
71167-004-032020-01-31C16284748780-19d75b9d0-9568-f424-e053-dadaa90a57ce71167-004
71167-004-042020-01-31C16284748780-19d75b9d0-9568-f424-e053-dadaa90a57ce71167-004
71167-004-052020-01-31C16284748780-19d75b9d0-9568-f424-e053-dadaa90a57ce71167-004
71167-004-062020-01-31C16284748780-19d75b9d0-9568-f424-e053-dadaa90a57ce71167-004
71167-004-072020-01-31C16284748780-19d75b9d0-9568-f424-e053-dadaa90a57ce71167-004
71167-004-082020-01-31C16284748780-19d75b9d0-9568-f424-e053-dadaa90a57ce71167-004
71167-004-092020-01-31C16284748780-19d75b9d0-9568-f424-e053-dadaa90a57ce71167-004
71167-004-102020-01-31C16284748780-19d75b9d0-9568-f424-e053-dadaa90a57ce71167-004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71167-004-01White-Glo whiting tooth24 in 1 BOXPASTE241
71167-004-01White-Glo whiting tooth150 g in 1 TUBEPASTE1501
71167-004-02White-Glo whiting tooth48 in 1 BOXPASTE481
71167-004-02White-Glo whiting tooth150 g in 1 TUBEPASTE1501
71167-004-03White-Glo whiting tooth100 g in 1 TUBEPASTE1001
71167-004-03White-Glo whiting tooth24 in 1 BOXPASTE241
71167-004-04White-Glo whiting tooth48 in 1 BOXPASTE481
71167-004-04White-Glo whiting tooth100 g in 1 TUBEPASTE1001
71167-004-05White-Glo whiting tooth80 g in 1 TUBEPASTE801
71167-004-05White-Glo whiting tooth20 in 1 BOXPASTE201
71167-004-06White-Glo whiting tooth40 in 1 BOXPASTE401
71167-004-06White-Glo whiting tooth80 g in 1 TUBEPASTE801
71167-004-07White-Glo whiting tooth144 in 1 BOXPASTE1441
71167-004-07White-Glo whiting tooth50 g in 1 TUBEPASTE501
71167-004-08White-Glo whiting tooth100 in 1 BOXPASTE1001
71167-004-08White-Glo whiting tooth24 g in 1 TUBEPASTE241
71167-004-09White-Glo whiting tooth188 in 1 BOXPASTE1881
71167-004-09White-Glo whiting tooth24 g in 1 TUBEPASTE241
71167-004-10White-Glo whiting tooth1000 in 1 BOXPASTE10001
71167-004-10White-Glo whiting tooth12 g in 1 TUBEPASTE121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71167-004WHITE-GLO WHITING TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE [HUAIAN ZONGHENG BIO-TECH CO., LTD]1Legacy NDC, 20 package rows20180202_64384dff-e2c6-2f96-e053-2a91aa0a9a5d.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71167-00471167-004-01, 71167-004-02, 71167-004-03, 71167-004-04, 71167-004-05, 71167-004-06, 71167-004-07, 71167-004-08, 71167-004-09, 71167-004-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHONDRUS CRISPUSOQS23HUA1XIACT
CALCIUM CARBONATEH0G9379FGKIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SORBITOL506T60A25RIACT
SODIUM SILICATEIJF18F77L3IACT
SODIUM LAURYL SULFATE368GB5141JIACT
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
POTASSIUM SODIUM SACCHARATE73U34YC90UIACT
ROSA CANINA FLOWER OILDUY7M48I1TIACT

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
64384dff-e2c5-2f96-e053-2a91aa0a9a5d64384dff-e2c6-2f96-e053-2a91aa0a9a5d2018-02-02WarningsExact identifier
spl id: 64384dff-e2c5-2f96-e053-2a91aa0a9a5d
spl set id: 64384dff-e2c6-2f96-e053-2a91aa0a9a5d

Reported adverse events (FAERS/openFDA)#

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