FDA.reportPublic FDA data

Hismile Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast

Product NDC
83013-331
11-digit product format
830130331
Labeler code
83013
Product ID
83013-331_3033b314-4dc3-d60c-e063-6394a90a1f9b
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
2025-01-09
Substance
SODIUM FLUORIDE
Active strength
.243 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Hismile Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416783Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2b3e72ca-2bbb-adf1-e063-6394a90a2c7aAvailable on FDA.report

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
83013-331-06Hismile Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast60 g in 1 BOTTLE, PUMPGEL602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83013-331HISMILE GRAPE BUBBLEGUM FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPAST (SODIUM FLUORIDE) GEL [HISMILE PTY LTD]2Current NDC, 1 package rows20250315_2b3e72ca-2bbb-adf1-e063-6394a90a2c7a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 39 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate MaxFresh Citrus FreshSODIUM FLUORIDEColgate-Palmolive Company13a74642-51d2-493c-ae97-a54508546a742025-06-12WarningsExact identifier
application number: M021
Colgate MaxFresh Watermelon BlastSODIUM FLUORIDEColgate-Palmolive Company4f07f945-6594-40f4-bc19-6acc12c37cdd2025-06-12WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.36994628-e5f3-3c35-e063-6294a90a609d2025-06-02WarningsExact identifier
application number: M021
EUTHYMOL WHITENING SPECIAL GIFT SETSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.35bfa3fc-106e-aecc-e063-6294a90a7eb02025-05-22WarningsExact identifier
application number: M021
EUTHYMOL WHITENING GIFT SET (40gX3)SODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369aa02f-c312-6a0d-e063-6294a90adaa52025-05-22WarningsExact identifier
application number: M021
EUTHYMOL WHITENING TRAVELSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.3596306e-858c-9bf7-e063-6294a90ac1d62025-05-20WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.3582cc91-8c32-9f93-e063-6394a90a87922025-05-19WarningsExact identifier
application number: M021
EUTHYMOL WHITENING SETSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.35839b10-4c40-40e5-e063-6294a90a85b42025-05-19WarningsExact identifier
application number: M021
Hello Unicorn SparkleSODIUM FLUORIDEColgate-Palmolive Company5acfbd9b-278c-24dd-8041-5e2cdffbf7102025-05-13WarningsExact identifier
application number: M021
Optimax Anticavity Fluoride Cotton CandySODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC25f182cb-ad1e-4c13-bc79-1ec251754cf82025-05-12WarningsExact identifier
application number: M021
Optimax Anticavity Fluoride WatermelonSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCb506df13-649f-4615-bc25-6ae08bd56b182025-05-12WarningsExact identifier
application number: M021
Listerine Total Care Alcohol Free Anticavity Fluoride Mouthwash Fresh MintSODIUM FLUORIDEKenvue Brands LLC346daeae-7590-176c-e063-6294a90a52ea2025-05-05WarningsExact identifier
application number: M021
Evo Sensitive Whitening Anti-cavity Fluoride MouthwashSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.3de0d71a-7704-97dd-e063-6294a90a5d2c2025-05-01WarningsExact identifier
application number: M021
Brush Buddies Value 2 pack WhiteningSODIUM MONOFLUOROPHOSPHATEAshtel Studios, Inc636bf51d-9750-4305-ab4a-3483c9f0169b2025-04-30WarningsExact identifier
application number: M021
Handy Solutions Crest Complete MULTI-BENEFIT WHITENING plus ScopeSODIUM FLUORIDENavajo Manufacturing Company Inc3adb1524-0fd6-4728-b757-dcbda4cdd0fb2025-04-29WarningsExact identifier
application number: M021
Listerine Clinical Solutions Enamel Strength Alpine MintSODIUM FLUORIDEKenvue Brands LLC11e1c1d0-465b-9e14-e063-6394a90a8cdd2025-04-22WarningsExact identifier
application number: M021
Hello Mighty Multi taskerSTANNOUS FLUORIDEColgate-Palmolive Company48e36e06-3666-9032-b9c8-4be035e751f22025-04-15WarningsExact identifier
application number: M021
Hello Kids Wild Strawberry Wild StrawberrySODIUM FLUORIDEColgate-Palmolive Company39dddf11-45a0-b883-e12f-d80c582e8c892025-04-15WarningsExact identifier
application number: M021
Hello Magical MermaidSODIUM FLUORIDEColgate-Palmolive Companybdabf74f-8d1e-0f11-159a-0025bcd0ca3e2025-04-15WarningsExact identifier
application number: M021
Euthymol Whitening Purple CorrectorSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.300303e7-ef8b-7449-e063-6294a90ac8112025-04-09WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN2b3e72ca-2bbb-adf1-e063-6394a90a2c7a2
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD2b3e72ca-2bbb-adf1-e063-6394a90a2c7a2
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY2b3e72ca-2bbb-adf1-e063-6394a90a2c7a2
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY2b3e72ca-2bbb-adf1-e063-6394a90a2c7a2
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY2b3e72ca-2bbb-adf1-e063-6394a90a2c7a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83013-331-068301303310660 g in 1 BOTTLE, PUMP (83013-331-06) 60 g2025-01-09NoNoCurrent