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 35 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gerigentle-Good morningSODIUM FLORIDEGeri-Gentle Corporatione69b3767-00c5-a535-e053-2995a90ad2152025-10-23WarningsExact identifier
application number: M021
Hello Penguin ChillSODIUM FLUORIDEColgate-Palmolive Company5c47a7d5-da34-4658-8006-b36f6477cb9b2025-10-23WarningsExact identifier
application number: M021
Auraglow WhiteningSODIUM FLUORIDEAuraglow LLC9d45e436-92f6-4a9e-9b82-329847dca9ba2025-10-22WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE ADVANCED VIBRANT CLEANSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyed20cf9d-6162-4337-bb0b-1a6a6e9e1dc32025-10-21WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitudede21b326-f885-464b-b2df-f3866a0b3e9a2025-10-20WarningsExact identifier
application number: M021
Target Kids Watermelon MintSODIUM FLUORIDETarget35bc2e4d-f1c7-438e-e063-6394a90aead02025-10-17WarningsExact identifier
application number: M021
MediChoice FluorideSODIUM MONOFLUOROPHOSPHATEO&M HALYARD, INC.a87956fa-8975-4a44-9e9a-4b2191e401fe2025-10-09WarningsExact identifier
application number: M021
BRUSH BUDDIES BARBIE ANTICAVITY FLUORIDE BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.1b6f893d-74ac-421e-a78b-f495ac425af02025-10-09WarningsExact identifier
application number: M021
BRUSH BUDDIES HOTWHEEL ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.a3e989f8-e6a2-4e13-8faa-77e95895166d2025-10-09WarningsExact identifier
application number: M021
TARGET UP AND UP ANTICAVITYSODIUM FLUORIDE 0.05%TARGET CORPORATION2992efce-1c66-df40-e063-6294a90ab3c02025-10-08WarningsExact identifier
application number: M021
MediChoice Premium Anticavity FluorideSODIUM FLUORIDEO&M HALYARD, INC.c6ba9b51-b958-4836-adc8-871529a43fc62025-10-08WarningsExact identifier
application number: M021
TidaloveSPICY CINNAMON TOOTHPASTE TABLETSParanmare LLC4092fcbf-27f7-b067-e063-6394a90a41c62025-10-07WarningsExact identifier
application number: M021
TidaloveCOOL MINT TOOTHPASTE TABLETSParanmare LLC4093060c-23a5-c77a-e063-6394a90a93042025-10-07WarningsExact identifier
application number: M021
TidaloveYUZU MINT TOOTHPASTE TABLETSParanmare LLC40946943-21cf-b114-e063-6394a90aed3f2025-10-07WarningsExact identifier
application number: M021
Optimax Purple Anticavity FluorideSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCfdb16e59-5be1-4bd0-a940-d542d67fb2df2025-10-02WarningsExact identifier
application number: M021
Intensive Enamel Repair Whitening TPINTENSIVE ENAMEL REPAIR WHITENING TPTopco Associates LLC3012a8da-7595-2f7c-e063-6294a90ae1202025-09-30WarningsExact identifier
application number: M021
Made by Dentists For Kids Eyeball Juice (Watermelon)SODIUM FLUORIDEMADE BY DENTISTS INCb2ad2b19-6fdf-454d-9b1d-49b1c81016fd2025-09-30WarningsExact identifier
application number: M021
ACT Restoring Anticavity Fluoride Mint BurstSODIUM FLUORIDEChattem, Inc.a38363e6-7105-4663-95a0-09ecb2948f832025-09-30WarningsExact identifier
application number: M021
UNPA CHA CHA TOOTHPASTESODIUM MONOFLUOROPHOSPHATEDONG IL PHARMS CO.,LTD3fae966e-0246-b9f2-e063-6394a90a494c2025-09-26WarningsExact identifier
application number: M021
Cloveden ToothSODIUM MONOFLUOROPHOSPHATEDONG IL PHARMS CO.,LTD3fb01bea-7205-49ba-e063-6294a90a38412025-09-26WarningsExact 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