FDA.reportPublic FDA data

Kids Crest

Product NDC
37000-839
Requested package NDC
37000-839-01
11-digit product format
370000839
Labeler code
37000
Product ID
37000-839_47e49826-a289-39ed-e063-6394a90a41d7
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-04-01
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
Kids Crest
Brand name suffix
Bubblegum Flavor
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
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
26a7a892-5da4-4749-bbb6-566efab7d749Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-05-18Kid's Crest Bubblegum Flavor
2023-05-18Kid's Crest Cavity Protection Bubblegum Flavor
2023-05-18Kid's Crest Cavity Protection Bubblegum Flavor
2023-01-30Kid's Crest Bubblegum Flavor
2023-01-30Kid's Crest Cavity Protection Bubblegum Flavor
2023-01-30Kid's Crest Cavity Protection Bubblegum Flavor
2021-02-12Kid's Crest Bubblegum Flavor
2021-02-12Kid's Crest Cavity Protection Bubblegum Flavor
2021-02-12Kid's Crest Cavity Protection Bubblegum Flavor
2021-01-29Kid's Crest Bubblegum Flavor
2021-01-29Kid's Crest Cavity Protection Bubblegum Flavor
2021-01-29Kid's Crest Cavity Protection Bubblegum Flavor

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-839-01Kids CrestBubblegum Flavor119 g in 1 TUBEPASTE, DENTIFRICE11914
37000-839-22Kids CrestBubblegum Flavor62 g in 1 TUBEPASTE, DENTIFRICE6214
37000-839-22Kids CrestBubblegum Flavor1 in 1 CARTONPASTE, DENTIFRICE114

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W7KIDS CREST BUBBLEGUM FLAVOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]2
Fluoride IonACTIVE MOIETYQ80VPU408OKIDS CREST BUBBLEGUM FLAVOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]2
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS311KIDS CREST BUBBLEGUM FLAVOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]2
cocamidopropyl betaineINACTIVE INGREDIENT5OCF3O11KXKIDS CREST BUBBLEGUM FLAVOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]2
d&c red no. 33INACTIVE INGREDIENT9DBA0SBB0LKIDS CREST BUBBLEGUM FLAVOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXKIDS CREST BUBBLEGUM FLAVOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]2
hydrated silicaINACTIVE INGREDIENTY6O7T4G8P9KIDS CREST BUBBLEGUM FLAVOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]2
micaINACTIVE INGREDIENTV8A1AW0880KIDS CREST BUBBLEGUM FLAVOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]2
polyethylene glycol 600INACTIVE INGREDIENTNL4J9F21N9KIDS CREST BUBBLEGUM FLAVOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]2
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TYKIDS CREST BUBBLEGUM FLAVOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]2
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUKIDS CREST BUBBLEGUM FLAVOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]2
sorbitolINACTIVE INGREDIENT506T60A25RKIDS CREST BUBBLEGUM FLAVOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPKIDS CREST BUBBLEGUM FLAVOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]2
waterINACTIVE INGREDIENT059QF0KO0RKIDS CREST BUBBLEGUM FLAVOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-839KIDS CREST BUBBLEGUM FLAVOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]11Current NDC, Legacy NDC, 3 package rows20250309_26a7a892-5da4-4749-bbb6-566efab7d749.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 1 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLGATE OPTIC WHITE STAIN FIGHTER FRESH MINTSODIUM FLUORIDEColgate-Palmolive Companyb1ef8277-9919-453c-9d21-da4666d952de2026-09-17WarningsExact identifier
application number: M021
TheraBreathSODIUM FLUORIDEChurch & Dwight Co., Inc.53c1086d-264b-9d00-e063-6394a90ad19d2026-09-09WarningsExact identifier
application number: M021
Opalescence Whitening Cool MintSODIUM FLUORIDEUltradent Products, Inc.44e7d0ed-3c37-5889-e063-6294a90afcca2026-09-09WarningsExact identifier
application number: M021
Opalescence WhiteningSODIUM FLUORIDEUltradent Products, Incd07f842e-b6f1-4ae1-b576-f542ecd02dd42026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence OriginalSODIUM FLUORIDEUltradent Products, Inc.5c3bf8fc-2e8f-4a58-bcbf-e47540072a492026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence CompleteOPAL BY OPALESCENCE COMPLETEUltradent Products, Inc.249cc46a-dad6-0345-e063-6394a90a44472026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh KnockoutSODIUM FLUORIDEColgate-Palmolive Company0ffbb3a9-7bfa-4f6a-aef3-fde327a410c92026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh CharcoalSODIUM FLUORIDEColgate-Palmolive Companyde3674f4-3ce6-47d5-8391-6ad6789d68d92026-09-09WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Incef108fff-a79c-4e8d-8bf0-3fe567f93eb82026-09-08WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Inc1a42cf2d-6c48-4e38-97bc-b6f2084bf39b2026-09-08WarningsExact identifier
application number: M021
Freshmint Premium Anticavity GelSODIUM FLUORIDENew World Imports, Incdfe564c1-2097-431d-93f0-cf423f2542482026-09-08WarningsExact identifier
application number: M021
Freshmint Anticavity FluorideSODIUM MONOFLUOROPHOSPHATENew World Imports, Inc5aff7e41-58cd-5ab8-e063-6294a90aa1c72026-09-08WarningsExact identifier
application number: M021
Colgate Optic White Advanced Sparkling WhiteSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companybc56603d-4190-48c1-b16e-3179a650cb392026-09-06WarningsExact identifier
application number: M021
Dentalclean Advanced ProSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda4d261dc8-b065-567f-e063-6294a90aa93f2026-09-04WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude54bd43c9-489d-4e6b-9031-90ec0e3c45162026-09-01WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude53c344e9-49f5-48aa-8309-1e15f80b80a02026-09-01WarningsExact identifier
application number: M021
UnpasteZERO WASTE FLUORIDE MINT TOOTH TABSAvespan LLC312ae88d-7ea4-b3e0-e063-6294a90a99e52026-09-01WarningsExact identifier
application number: M021
Dentalclean Regenerator Sensitive Dental Gel with FluorideSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda176aa3ed-e2a4-536d-e063-6294a90aa0972026-08-31WarningsExact identifier
application number: M021
Listerine Total Care Fresh Mint AnticavitySODIUM FLUORIDEKenvue Brands LLCb2ce66c3-dc48-47a5-a731-5550bc1946792026-08-28WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEYour Military Exchangescef74e9c-d3b5-4e92-9908-187be97b63ab2026-08-28Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN26a7a892-5da4-4749-bbb6-566efab7d74914
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD26a7a892-5da4-4749-bbb6-566efab7d74914
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY26a7a892-5da4-4749-bbb6-566efab7d74914
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY26a7a892-5da4-4749-bbb6-566efab7d74914
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY26a7a892-5da4-4749-bbb6-566efab7d74914
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY26a7a892-5da4-4749-bbb6-566efab7d74914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-839-0137000083901119 g in 1 TUBE (37000-839-01) 119 g2011-04-010000-00-00NoNoCurrent