FDA.reportPublic FDA data

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

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
Strawberry 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
891775Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
426c2aca-ca2b-5e34-e063-6294a90ae37cAvailable 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
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

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 20 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Cavity Protection Great Regular FlavorANTICAVITY FLUORIDE TOOTHPASTEColgate-Palmolive Company202c6c62-e16a-4716-babe-d5414006c79e2026-01-21WarningsExact identifier
application number: M021
Crest 3D White Luxe Diamond StrongSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc1420129-5460-4900-ac9a-356d2d7c60a22026-01-21WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Max Cavity and Erosion PreventionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company48eb0bdc-7399-745d-e063-6294a90a98092026-01-21WarningsExact identifier
application number: M021
Colgate Total Gum Protect WhiteningSTANNOUS FLUORIDEColgate-Palmolive Companydcf81dcb-b26b-4411-82d4-5f7e9d3fc0f32026-01-20WarningsExact identifier
application number: M021
GuruNanda Anti-CavitySODIUM FLUORIDEGURUNANDA, LLC3b07b72f-4efc-eb0f-e063-6294a90a70a82026-01-19WarningsExact identifier
application number: M021
GuruNanda AnticavitySODIUM FLUORIDEGURUNANDA, LLC3e90d516-3172-3c8d-e063-6294a90a394f2026-01-19WarningsExact identifier
application number: M021
HismilePEACH ICED TEA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0eba92d1-cbdc-9c96-e063-6294a90a9afc2026-01-15WarningsExact identifier
application number: M021
HismileCOCONUT WHIP FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef3cfb6-6bae-1682-e063-6394a90aca882026-01-15WarningsExact identifier
application number: M021
HismileMANGO SORBET FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef3f4f8-fdc4-2056-e063-6394a90a6fd72026-01-15WarningsExact identifier
application number: M021
HismileSMOOTH MINT FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef41051-dfa0-b105-e063-6294a90a551f2026-01-15WarningsExact identifier
application number: M021
HismileWATERMELON FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef43107-58ec-d4ee-e063-6294a90ad8d72026-01-15WarningsExact identifier
application number: M021
HismileRED VELVET FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef56539-dc21-c6ea-e063-6394a90a57902026-01-15WarningsExact identifier
application number: M021
HismileGRAPE BUBBLEGUM FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef6f8b5-8565-b364-e063-6294a90aabbc2026-01-15WarningsExact identifier
application number: M021
HismileSTRAWBERRY FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef766ae-754a-f185-e063-6294a90a32992026-01-15WarningsExact identifier
application number: M021
HismileBANANA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef7be5b-df8f-9f32-e063-6394a90a47242026-01-15WarningsExact identifier
application number: M021
HismileVANILLA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef8d0ef-a051-f610-e063-6394a90a85372026-01-15WarningsExact identifier
application number: M021
HISMILESODIUM FLUORIDEHISMILE PTY LTD1d40b98b-2e9a-d84a-e063-6294a90a20962026-01-15WarningsExact identifier
application number: M021
HISMILESODIUM FLUORIDEHISMILE PTY LTD1d44863e-93be-2b80-e063-6294a90a4a9d2026-01-15WarningsExact identifier
application number: M021
HISMILESODIUM FLUORIDEHISMILE PTY LTD1d458ccc-8f1e-f9c8-e063-6294a90a8da42026-01-15WarningsExact identifier
application number: M021
HISMILESODIUM FLUORIDEHISMILE PTY LTD1d447939-fbf6-42f6-e063-6294a90af6d92026-01-15WarningsExact identifier
application number: M021

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 g2025-10-31NoNoCurrent