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 41 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quip AnticavitySODIUM FLUORIDEQuip NYC Inc.b6d8a9b6-1fdd-6a54-e053-2995a90a2c1a2025-01-30WarningsExact identifier
application number: M021
QuipSODIUM FLUORIDEQuip NYC Inc.714b7205-444d-929b-e053-2995a90a958e2025-01-30WarningsExact identifier
application number: M021
Brush Buddies MY LITTLE PONY ANTICAVITY FLUORIDESODIUM FLUORIDEAshtel Studios, Inc.7e8944d3-b8d6-44e6-b38b-f80e4cd28ee42025-01-29WarningsExact identifier
application number: M021
Cool sense Care PlusSODIUM FLUORIDEDOCSMEDI Co., Ltd.ea18ac56-4ef1-4bf0-8c26-6885183fd6842025-01-22WarningsExact identifier
application number: M021
DOCTRUST DOUBLEX ToothSODIUM FLUORIDEDOCSMEDI Co., Ltd.aaf08481-a2ff-48f6-8611-73a469efe1db2025-01-22WarningsExact identifier
application number: M021
Double X CONCENTRATEDCETYLPYRIDINIUM CHLORIDEDOCSMEDI Co., Ltd.411be334-364c-4074-8d0b-8dda332f87de2025-01-22WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Quebec Inc. DBA Attituded33e3778-ba1d-4560-bafa-74f7ab88c6b52025-01-20WarningsExact identifier
application number: M021
AMERFRESH FLUORIDE gelSODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTD86279b4d-82e5-45b5-9ba7-94fe3620b8502025-01-16WarningsExact identifier
application number: M021
AMERFRESH FLUORIDESODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTD827e45bb-84c0-48ee-a60b-2cc32b8f33e32025-01-16WarningsExact identifier
application number: M021
Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel ToothSODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTDbb93fb1a-885a-4d2a-a1c2-3b37bc305d572025-01-16WarningsExact identifier
application number: M021
MedprideSODIUM MONOFLUOROPHOSPHATEShield Line LLC9c1b0420-6b57-4914-99fe-df6a494815c32025-01-16WarningsExact identifier
application number: M021
Sodium FluorideSODIUM FLUORIDESafco Dental Supply LLC7a295974-c400-4442-9149-138a805ffb202025-01-09WarningsExact identifier
application number: M021
SaliveaFLUORIDE TOOTHPASTELaclede, Inc.6398ae96-dd38-44da-bc34-1d4d4c4a78ca2025-01-08WarningsExact identifier
application number: M021
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDETai Guk Pharm. Co., Ltd.098a29d5-3836-d362-e063-6394a90a9fea2025-01-01WarningsExact identifier
application number: M021
PERIOE POP Sensitivity Care Prebiotic Clean MintSTANNOUS FLUORIDETai Guk Pharm. Co., Ltd.f4ef8ee7-7197-b3dc-e053-2a95a90a1c1b2025-01-01WarningsExact identifier
application number: M021
PERIOE Microbiome Sensitive Clean MintSTANNOUS FLUORIDETai Guk Pharm. Co., Ltd.dec29c9f-6ddb-0b4e-e053-2995a90a64b12025-01-01WarningsExact identifier
application number: M021
AVON Whitening Essentials Original Cool MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.8e5de76b-535a-9c95-e053-2995a90afcab2025-01-01WarningsExact identifier
application number: M021
AVON Whitening Essentials Blanc Charcoal Fresh MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.8f27c88a-7a70-e00a-e053-2a95a90a95a42025-01-01WarningsExact identifier
application number: M021
POP Feeling PeachySODIUM FLUORIDETAI GUK PHARM. CO., LTD0abb7a95-60b1-a1f3-e063-6294a90ace0c2025-01-01WarningsExact identifier
application number: M021
AVON Whitening Essentials Blanc Charcoal Fresh MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.99fff177-6300-220e-e053-2a95a90a06602025-01-01WarningsExact 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