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 45 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Total SF Advanced WhiteningSTANNOUS FLUORIDEColgate-Palmolive Companycef9a30c-a18c-47e9-b276-f56608f0400f2024-10-01WarningsExact identifier
application number: M021
Colgate Total SF WhiteningSTANNOUS FLUORIDEColgate-Palmolive Company86c4b51e-b086-4566-8f94-a951bf0c62542024-09-30WarningsExact identifier
application number: M021
Colgate Total Whitening Fresh BoostSTANNOUS FLUORIDEColgate-Palmolive Companyc436382e-2755-c882-2970-4be1b9ca537b2024-09-30WarningsExact identifier
application number: M021
Colgate Total SF Whitening GelSTANNOUS FLUORIDEColgate-Palmolive Company27c4eed5-9121-4e09-9d42-e0a3e84301092024-09-30WarningsExact identifier
application number: M021
Colgate Total Whitening CharcoalSTANNOUS FLUORIDEColgate-Palmolive Company56434e3d-ba0a-8b42-6c97-0d00556067932024-09-30WarningsExact identifier
application number: M021
Colgate Total SF Mint Stripe GelSTANNOUS FLUORIDEColgate-Palmolive Companyabfbcacd-9c1a-4472-9e91-a85e78050a9e2024-09-30WarningsExact identifier
application number: M021
Colgate Total SF Advanced WhiteningSTANNOUS FLUORIDEColgate-Palmolive Companyf8aeac8e-6a3e-4ada-bb13-db337b934ba32024-09-27WarningsExact identifier
application number: M021
OCEAN FRIENDS ANTICAVITY FLUORIDE WATERMELON FLAVORSODIUM FLUORIDECVS Pharmacy, Inc.4a68bd30-91d3-46c9-a3d4-4fe342b5e6ef2024-09-27WarningsExact identifier
application number: M021
Colgate Total SF Advanced Deep CleanSTANNOUS FLUORIDEColgate-Palmolive Company92642408-4465-4f8f-85f9-cf12aadc147b2024-09-27WarningsExact identifier
application number: M021
Brush Buddies SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FLAVORSODIUM FLUORIDEAshtel Studios Inc.b197ac2d-f9d6-4937-a0a6-2f425e4c37962024-09-26WarningsExact identifier
application number: M021
Brush Buddies SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FLAVORSODIUM FLUORIDEAshtel Studios, Incdc04ee5c-3561-4579-8f9b-00266a8c88712024-09-25WarningsExact identifier
application number: M021
Made by Dentists For Kids Cheetah Dust (Strawberry)SODIUM FLUORIDEMADE BY DENTISTS INC94939abe-b05e-4ea2-a1a6-204da857b4aa2024-09-18WarningsExact identifier
application number: M021
ACT Anticavity Fluoride Arctic BlastSODIUM FLUORIDEChattem, Inc.2d5c1ce7-3c3e-415e-9469-a8d3ddfe2c572024-08-22WarningsExact identifier
application number: M021
CinnaFreshSODIUM FLUORIDEBob Barker Company Inc.3fbd95f0-a10c-4351-ad80-7e90b2d6a6f52024-08-22WarningsExact identifier
application number: M021
Karl and Hans Botanic Double MintSODIUM MONOFLUOROPHOSPHATEPIGEON CORPORATIONd1233fc3-047c-4e26-bb2b-8ebde09c05a92024-08-08WarningsExact identifier
application number: M021
Karl and Hans Botanic JasmineSODIUM MONOFLUOROPHOSPHATEPIGEON CORPORATION6c0335e6-f041-48c7-9da3-88c124b84b002024-08-08WarningsExact identifier
application number: M021
OMNISTANNOUS FLUORIDESolventum US LLC0c2a81b1-65b5-432b-8e66-30432a245aba2024-08-01WarningsExact identifier
application number: M021
Just For KidsSTANNOUS FLUORIDESolventum US LLC0f1afc36-f699-4072-b90b-c9f5be989a492024-08-01WarningsExact identifier
application number: M021
Clinpro Tooth CremeSODIUM FLUORIDESolventum US LLC786c6184-6bc8-4376-9ce2-3e35af1932102024-08-01WarningsExact identifier
application number: M021
PerioMedSTANNOUS FLUORIDESolventum US LLC7f79eb00-86df-4284-b415-47f45e4849da2024-08-01WarningsExact 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