Hello Dragon Dazzle

Product NDC
35000-679
11-digit product format
350000679
Labeler code
35000
Product ID
35000-679_62f60e83-181a-4384-a0f5-74fb5eac99c1
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-01
Substance
SODIUM FLUORIDE
Active strength
1.5 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Hello Dragon Dazzle
Brand name suffix
Dragon Dazzle Fluoride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.5 mg/g

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
eaca1ad1-9e31-b904-4148-247ad2460661Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-679-10Hello Dragon Dazzle Dragon Dazzle Fluoride119 g in 1 TUBEPASTE, DENTIFRICE1194
35000-679-10Hello Dragon Dazzle Dragon Dazzle Fluoride1 in 1 CARTONPASTE, DENTIFRICE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-679HELLO DRAGON DAZZLE DRAGON DAZZLE FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]3Current NDC, 2 package rows20240120_eaca1ad1-9e31-b904-4148-247ad2460661.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 10 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Frida Fluoride Sweet MintSODIUM FLUORIDEFridababy, LLC4f8b5a39-5d79-72cd-e063-6394a90a475c2026-05-06WarningsExact identifier
application number: M021
Frida Fluoride Bubble MintSODIUM FLUORIDEFridababy, LLC4f8b9af3-e4b3-b5e0-e063-6394a90a10682026-05-06WarningsExact identifier
application number: M021
Frida Fluoride Strawberry Toothbrush SetSODIUM FLUORIDEFridababy, LLC4f8ba14f-60ea-c2a8-e063-6394a90a77022026-05-06WarningsExact identifier
application number: M021
Frida Fluoride StrawberrySODIUM FLUORIDEFridababy, LLC4f814a62-8f91-8ea6-e063-6294a90a69eb2026-05-06WarningsExact identifier
application number: M021
Gum Health DetoxifySTANNOUS FLUORIDEMeijer, Inc41d70733-a223-40fb-e063-6294a90a13972026-05-06WarningsExact identifier
application number: M021
Colgate Kids Unicorn Alcohol FreeSODIUM FLUORIDEColgate-Palmolive Company133acaff-7205-80d7-e91d-3eb37087cae42026-05-05WarningsExact identifier
application number: M021
Crest 3D White Stain EraserSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.fdefffbd-9c05-fa30-e053-6394a90a34bc2026-05-05WarningsExact identifier
application number: M021
Frida Fluoride WatermelonSODIUM FLUORIDEFridababy, LLC4f8b49dc-e9e4-c341-e063-6294a90adb5a2026-05-05WarningsExact identifier
application number: M021
White Glo Extreme White WhiteningSODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inc4a2e0a8d-420e-4c07-aa43-386d05dab4722026-04-30WarningsExact identifier
application number: M021
Equate Pro-Advanced TP Equate Pro-Advanced TPSTANNOUS FLUORIDEWalmart Inc.1e6561fb-4e3b-40ba-e063-6294a90a26902026-04-29WarningsExact identifier
application number: M021
Crest Cavity Protection RegularSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.852889b4-59ba-4592-b4fc-c0127a1ad0752026-04-28WarningsExact identifier
application number: M021
Crest Complete Multi-Benefit Whitening plus ScopeSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.0206710a-707f-4aa9-96b9-86240c1275dc2026-04-28WarningsExact identifier
application number: M021
Alcohol Free Refreshing MintSODIUM FLUORIDEH E Bcedf7c08-7412-4733-9b67-225b331cec8c2026-04-27Warnings, Adverse reactionsExact identifier
application number: M021
anzoon ANTIBACTERIAL MOUTH WASHCETYLPYRIDINIUM CHLORIDEShandong AZC Biotechnology Co.,Ltd.507c6896-2806-790c-e063-6394a90ac5ce2026-04-27WarningsExact identifier
application number: M021
DELTA COMFORT PLUS AMENITYSODIUM MONOFLUOROPHOSPHATEBuzz Products Inc.26434794-ae02-0f58-e063-6294a90ad85e2026-04-24WarningsExact identifier
application number: M021
A and H Plus Therabreath Breath FreshnersSODIUM FLUORIDEChurch & Dwight Co., Inc.18d6073e-b1ee-47d2-9758-2cf04f3cf3ca2026-04-23WarningsExact identifier
application number: M021
FluorideSODIUM FLUORIDEMcKesson5025e58e-e59c-07b6-e063-6394a90ac1e82026-04-23WarningsExact identifier
application number: M021
PRO-SYSSENSITIVITY - MINT (OTC)Benco Dental4e46847e-8c1d-c988-e063-6394a90a8e502026-04-22WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEH E B87327a36-a314-4daa-83b6-b4bd3e26bba22026-04-22Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEH E B8df324a7-9204-40f3-8ddb-1656286d7d4e2026-04-22Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSNeaca1ad1-9e31-b904-4148-247ad24606614
416783sodium fluoride 0.0024 MG/MG ToothpasteSCDeaca1ad1-9e31-b904-4148-247ad24606614
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSYeaca1ad1-9e31-b904-4148-247ad24606614
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYeaca1ad1-9e31-b904-4148-247ad24606614
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYeaca1ad1-9e31-b904-4148-247ad24606614

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35000-679-10350000679101 TUBE in 1 CARTON (35000-679-10) / 119 g in 1 TUBE1 tube2023-07-01NoNoCurrent