Hismile Miffy Sweet Apple Flavor Sodium Fluoride Anticavity Toothpast

Product NDC
83013-333
11-digit product format
830130333
Labeler code
83013
Product ID
83013-333_3033da13-e5af-4341-e063-6294a90a1e80
Type
HUMAN OTC DRUG
Nonproprietary name
sodium fluoride
Dosage form
GEL
Route
ORAL
Labeler
Hismile Pty Ltd
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-14
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 Miffy Sweet Apple 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
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
83013-333-06Hismile Miffy Sweet Apple Flavor Sodium Fluoride Anticavity Toothpast60 g in 1 BOTTLE, PUMPGEL602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83013-333HISMILE MIFFY SWEET APPLE FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPAST (SODIUM FLUORIDE) GEL [HISMILE PTY LTD]2Current NDC, 1 package rows20250315_2ba2318e-7a58-7b68-e063-6394a90ae784.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN2ba2318e-7a58-7b68-e063-6394a90ae7842
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD2ba2318e-7a58-7b68-e063-6394a90ae7842
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY2ba2318e-7a58-7b68-e063-6394a90ae7842
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY2ba2318e-7a58-7b68-e063-6394a90ae7842
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY2ba2318e-7a58-7b68-e063-6394a90ae7842

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83013-333-068301303330660 g in 1 BOTTLE, PUMP (83013-333-06) 60 g2025-01-14NoNoCurrent