Hismile

Product NDC
83013-335
11-digit product format
830130335
Labeler code
83013
Product ID
83013-335_309366f8-6a53-fe9f-e063-6394a90a5de3
Type
HUMAN OTC DRUG
Nonproprietary name
Magically Delicious Flavor Sodium Fluoride Anticavity Toothpaste
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Hismile Pty Ltd
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-01
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
Hismile
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui416783

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83013-335-06Hismile60 g in 1 BOTTLE, PUMPGEL, DENTIFRICE601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN309366f8-6a52-fe9f-e063-6394a90a5de31
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD309366f8-6a52-fe9f-e063-6394a90a5de31
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY309366f8-6a52-fe9f-e063-6394a90a5de31
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY309366f8-6a52-fe9f-e063-6394a90a5de31
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY309366f8-6a52-fe9f-e063-6394a90a5de31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83013-335-068301303350660 g in 1 BOTTLE, PUMP (83013-335-06) 60 g2025-06-01NoNoHistorical