FDA.reportPublic FDA data

ZONSEN Gel Fluoride

Product NDC
72932-015
11-digit product format
729320015
Labeler code
72932
Product ID
72932-015_2dd96dc3-8127-5132-e063-6294a90a28a8
Type
HUMAN OTC DRUG
Nonproprietary name
Gel Fluoride Toothpaste
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Wuhan Zonsen Medical Products Co., Ltd.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-11
Substance
SODIUM FLUORIDE
Active strength
.22 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZONSEN Gel Fluoride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.22 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui245598

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245598sodium fluoride 0.22 % ToothpastePSN2c1e40c9-8314-46ac-e063-6294a90a84ba2
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD2c1e40c9-8314-46ac-e063-6294a90a84ba2
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY2c1e40c9-8314-46ac-e063-6294a90a84ba2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72932-015-007293200150017 g in 1 TUBE (72932-015-00) 17 g2025-05-20NoNoCurrent
72932-015-017293200150124 g in 1 TUBE (72932-015-01) 24 g2025-05-20NoNoCurrent
72932-015-027293200150243 g in 1 TUBE (72932-015-02) 43 g2025-05-20NoNoCurrent
72932-015-037293200150378 g in 1 TUBE (72932-015-03) 78 g2025-05-20NoNoCurrent