FDA.reportPublic FDA data

Orazen Kids Anticavity Toothpaste

Manufacturer
Orazen Inc | YANGZHOU One & Only
Effective date
2026-06-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-06-11 05:10:34

Label at a glance#

ProductOrazen
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                               

Sodium Monofluorophosphate 0.76%

OTC - PURPOSE SECTION

Purpose
Anti-Cavity Toothpaste

INDICATIONS & USAGE SECTION

Use: Helps prevent against cavities

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

WARNINGS SECTION

Warnings: If you accidentally swallow more than used for brushing,get medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions:adults and children 2yrs.and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. To minimize swallowing use a pea sized amount in children under 6. Supervise children's brushing until good habits are established. Children under 2 yrs.:ask a dentist

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Sorbitol, Hydrated Silica, Water, Peg-8, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Sodium Saccharin, Trisodium Phospate, Mica, Sodium Benzoate, CI 73015

DESCRIPTION SECTION

Orazen

Orazen Inc

Somerset, NJ 08873

Questions 888-349-7897

Info@orazeninc.com

Made in China/Hecho en China

Fabrique en Chine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ora-Zen Anticavity Toothpaste

Bubblegum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube ArtTube Art

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71927-102-012025-01-30C16284748780-12cef2736-a85f-d83d-e063-dadaa90ab31fOrazen Kids Anticavity Toothpaste
71927-102-012025-01-30C16284748780-12cef2736-a85f-d83d-e063-dadaa90ab31fOrazen Kids Anticavity Toothpaste

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
71927-10271927-102-01

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
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SODIUM LAURYL SULFATE368GB5141JIACT
MICAV8A1AW0880IACT
SODIUM BENZOATEOJ245FE5EUIACT
TRISODIUM PHOSPHIDEA360RQX9W2IACT
FD&C BLUE NO. 2L06K8R7DQKIACT
POTASSIUM SODIUM SACCHARATE73U34YC90UIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22023-08-13full-release2026-05-31 23:55:53

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
OrazenSODIUM MONOFLUOROPHOSPHATEOrazen Incfa5b6bd8-443f-79e7-e053-6394a90a55132026-06-03WarningsExact identifier
ndc (package): 71927-102-01
ndc (product): 71927-102
ndc11 (package): 71927010201
spl id: 536042f4-24c3-0778-e063-6294a90aaf42
spl set id: fa5b6bd8-443f-79e7-e053-6394a90a5513

Reported adverse events (FAERS/openFDA)#

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