FDA.reportPublic FDA data

ZONSEN Gel Fluoride

Manufacturer
Wuhan Zonsen Medical Products Co., Ltd.
Effective date
2025-02-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:54:54

Label at a glance#

ProductZONSEN Gel Fluoride
Active ingredientSODIUM FLUORIDE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.22%

OTC - PURPOSE SECTION

Anticavity

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities.

WARNINGS SECTION

Keep out of the 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 immediately.

DOSAGE & ADMINISTRATION SECTION

Do not swallow, supervise children as necessary until capable of using without supervision. Instruct Children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children under 6 years of age: Do not use unless directed by a doctor or dentist.

INACTIVE INGREDIENT SECTION

Water, Carboxymethyl cellulose Sodium, Saccharin sodium,Sodium benzoate, Sorbitol, Sodium lauryl sulfate,Flavor,Silicon Dioxide, Xanthan gum

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the 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 immediately.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZONSEN NDC: 72932-015-00

Oral Care

Gel Fluoride Toothpaste

FRESH MINT FLAVOR

0.6 OZ. (17 g)

ZONSEN NDC: 72932-015-00 Oral Care Gel Fluoride Toothpaste FRESH MINT FLAVOR 0.6 OZ. (17 g)ZONSEN NDC: 72932-015-00 Oral Care Gel Fluoride Toothpaste FRESH MINT FLAVOR 0.6 OZ. (17 g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZONSEN NDC: 72932-015-01

Oral Care

Gel Fluoride Toothpaste

FRESH MINT FLAVOR

0.85 OZ. (24 g)

ZONSEN NDC: 72932-015-01 Oral Care Gel Fluoride Toothpaste FRESH MINT FLAVOR 0.85 OZ. (24 g)ZONSEN NDC: 72932-015-01 Oral Care Gel Fluoride Toothpaste FRESH MINT FLAVOR 0.85 OZ. (24 g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZONSEN NDC: 72932-015-02

Oral Care

Gel Fluoride Toothpaste

FRESH MINT FLAVOR

1.5 OZ. (43 g)

ZONSEN NDC: 72932-015-02 Oral Care Gel Fluoride Toothpaste FRESH MINT FLAVOR 1.5 OZ. (43 g)ZONSEN NDC: 72932-015-02 Oral Care Gel Fluoride Toothpaste FRESH MINT FLAVOR 1.5 OZ. (43 g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZONSEN NDC: 72932-015-03

Oral Care

Gel Fluoride Toothpaste

FRESH MINT FLAVOR

2.75 OZ. (78 g)

ZONSEN NDC: 72932-015-03 Oral Care Gel Fluoride Toothpaste FRESH MINT FLAVOR 2.75 OZ. (78 g)ZONSEN NDC: 72932-015-03 Oral Care Gel Fluoride Toothpaste FRESH MINT FLAVOR 2.75 OZ. (78 g)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
245598sodium fluoride 0.22 % ToothpastePSN2
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD2
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72932-015-00ZONSEN Gel Fluoride17 g in 1 TUBEGEL, DENTIFRICE172
72932-015-01ZONSEN Gel Fluoride24 g in 1 TUBEGEL, DENTIFRICE242
72932-015-02ZONSEN Gel Fluoride43 g in 1 TUBEGEL, DENTIFRICE432
72932-015-03ZONSEN Gel Fluoride78 g in 1 TUBEGEL, DENTIFRICE782

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72932-015ZONSEN GEL FLUORIDE (GEL FLUORIDE TOOTHPASTE) GEL, DENTIFRICE [WUHAN ZONSEN MEDICAL PRODUCTS CO., LTD.]2Current NDC, 4 package rows20250213_2c1e40c9-8314-46ac-e063-6294a90a84ba.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72932-01572932-015-00, 72932-015-01, 72932-015-02, 72932-015-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM LAURYL SULFATE368GB5141JIACT
XANTHAN GUMTTV12P4NEEIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB
WATER059QF0KO0RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT

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
ZONSEN Gel FluorideGEL FLUORIDE TOOTHPASTEWuhan Zonsen Medical Products Co., Ltd.2c1e40c9-8314-46ac-e063-6294a90a84ba2025-02-11WarningsExact identifier
ndc (package): 72932-015-02
ndc (package): 72932-015-03
ndc (package): 72932-015-01
ndc (package): 72932-015-00
ndc (product): 72932-015
ndc11 (package): 72932001501
ndc11 (package): 72932001503
ndc11 (package): 72932001502
ndc11 (package): 72932001500
spl id: 2dd96dc3-8127-5132-e063-6294a90a28a8
spl set id: 2c1e40c9-8314-46ac-e063-6294a90a84ba

Reported adverse events (FAERS/openFDA)#

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