Strawberry Flavor Sodium Fluoride Anticavity Toothpast

Product NDC
83013-339
11-digit product format
830130339
Labeler code
83013
Product ID
83013-339_42a6e1a2-ee38-0233-e063-6294a90a5ab0
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
GEL
Route
TOPICAL
Labeler
HISMILE PTY LTD
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-31
Substance
SODIUM FLUORIDE
Active strength
.243 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
Strawberry Flavor Sodium Fluoride Anticavity Toothpast
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.243 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui891775

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83013-339-10Strawberry Flavor Sodium Fluoride Anticavity Toothpast100 g in 1 TUBEGEL1002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN426c2aca-ca2b-5e34-e063-6294a90ae37c2
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD426c2aca-ca2b-5e34-e063-6294a90ae37c2
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY426c2aca-ca2b-5e34-e063-6294a90ae37c2
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY426c2aca-ca2b-5e34-e063-6294a90ae37c2
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY426c2aca-ca2b-5e34-e063-6294a90ae37c2
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY426c2aca-ca2b-5e34-e063-6294a90ae37c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83013-339-1083013033910100 g in 1 TUBE (83013-339-10) 100 g2025-10-31NoNoHistorical