Hismile

Product NDC
83013-327
11-digit product format
830130327
Labeler code
83013
Product ID
83013-327_4879b95b-12f8-e9c9-e063-6294a90a9f28
Type
HUMAN OTC DRUG
Nonproprietary name
Candy Cane Flavor Sodium Fluoride Anticavity Toothpaste
Dosage form
GEL
Route
DENTAL
Labeler
HISMILE PTY LTD
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-23
Substance
SODIUM FLUORIDE
Active strength
.243 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hismile
Listing expiration
2027-12-31

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
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83013-327-06Hismile60 g in 1 BOTTLE, PUMPGEL602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83013-327HISMILE (CANDY CANE FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE) GEL [HISMILE PTY LTD]1Current NDC, 1 package rows20240731_1e725b7e-accc-f51c-e063-6394a90a455c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN1e725b7e-accc-f51c-e063-6394a90a455c2
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD1e725b7e-accc-f51c-e063-6394a90a455c2
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY1e725b7e-accc-f51c-e063-6394a90a455c2
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY1e725b7e-accc-f51c-e063-6394a90a455c2
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY1e725b7e-accc-f51c-e063-6394a90a455c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83013-327-068301303270660 g in 1 BOTTLE, PUMP (83013-327-06) 60 g2024-07-30NoNoCurrent