FDA.reportPublic FDA data

Crest 3D White

Product NDC
37000-945
11-digit product format
370000945
Labeler code
37000
Product ID
37000-945_47e2ff33-29d9-6dd9-e063-6394a90a5387
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Procter & Gamble Manfuacturing Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-01
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
Crest 3D White
Brand name suffix
Charcoal
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
96247083-39e9-7ca7-e053-2995a90a75d0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-945-02Crest 3D WhiteCharcoal2 in 1 CELLO PACKPASTE, DENTIFRICE210
37000-945-02Crest 3D WhiteCharcoal1 in 1 CARTONPASTE, DENTIFRICE110
37000-945-03Crest 3D WhiteCharcoal3 in 1 CELLO PACKPASTE, DENTIFRICE310
37000-945-03Crest 3D WhiteCharcoal1 in 1 CARTONPASTE, DENTIFRICE110
37000-945-27Crest 3D WhiteCharcoal76 g in 1 TUBEPASTE, DENTIFRICE7610
37000-945-27Crest 3D WhiteCharcoal1 in 1 CARTONPASTE, DENTIFRICE110
37000-945-30Crest 3D WhiteCharcoal85 g in 1 TUBEPASTE, DENTIFRICE8510
37000-945-30Crest 3D WhiteCharcoal1 in 1 CARTONPASTE, DENTIFRICE110
37000-945-38Crest 3D WhiteCharcoal108 g in 1 TUBEPASTE, DENTIFRICE10810
37000-945-38Crest 3D WhiteCharcoal1 in 1 CARTONPASTE, DENTIFRICE110
37000-945-41Crest 3D WhiteCharcoal116 g in 1 TUBEPASTE, DENTIFRICE11610
37000-945-41Crest 3D WhiteCharcoal1 in 1 CARTONPASTE, DENTIFRICE110
37000-945-76Crest 3D WhiteCharcoal1 in 1 CARTONPASTE, DENTIFRICE110
37000-945-76Crest 3D WhiteCharcoal2 in 1 CELLO PACKPASTE, DENTIFRICE210
37000-945-82Crest 3D WhiteCharcoal116 g in 1 TUBEPASTE, DENTIFRICE11610
37000-945-82Crest 3D WhiteCharcoal2 in 1 CARTONPASTE, DENTIFRICE210

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-945CREST 3D WHITE CHARCOAL (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANFUACTURING COMPANY]7Current NDC, Legacy NDC, 16 package rows20250110_96247083-39e9-7ca7-e053-2995a90a75d0.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 4 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TOMS OF MAINE ACTIVATED CHARCOAL PEPPERMINTSODIUM FLUORIDETom's of Maine, Inc.b9e6e455-8444-4805-89f1-ee9142f98e362026-08-10WarningsExact identifier
application number: M021
TOMS OF MAINE WHOLE CARE SPEARMINTSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.7db8e49d-1073-4a81-a3a4-f3a19ebce9212026-08-10WarningsExact identifier
application number: M021
TOMS OF MAINE WHITEN PLUS DEEP CLEAN SPEARMINTSODIUM FLUORIDETom's of Maine, Inc.1fe50b49-bc62-4137-866c-e87bb878a96d2026-08-10WarningsExact identifier
application number: M021
Colgate Optic White Stain Fighter With Baking SodaSODIUM FLUORIDEColgate-Palmolive Company8e6113e2-101b-4bde-90e9-6ab32c6ebf5c2026-08-05WarningsExact identifier
application number: M021
COLGATE MAX FRESH WATERMELON BLASTSODIUM FLUORIDEColgate-Palmolive Company6c391ef3-d625-403c-a4dc-6e2212682ed12026-08-04WarningsExact identifier
application number: M021
Rorobell WaWa ToothSODIUM MONOFLUOROPHOSPHATEROROBELL93113481-ad9d-4be0-a7b7-a72c8726127d2026-08-03WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE CHARCOALSODIUM FLUORIDEColgate-Palmolive Company70ed4a93-b68f-4198-b4b7-7cfeb17ba5d22026-07-30WarningsExact identifier
application number: M021
Colgate Optic White CharcoalSODIUM FLUORIDEColgate-Palmolive Company82ac5b9d-19e8-46ac-a195-c7d85f2967d52026-07-30WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Peppy Mint 1.4 ozSODIUM MONOFLUOROPHOSPHATERobell Research, Inc251264ea-20d2-be19-e063-6394a90aa5f62026-07-29WarningsExact identifier
application number: M021
Natural White Sensitive Enamel Guard Alpine MintSODIUM FLUORIDELornamead Products2e832204-ba2d-6dcb-e063-6394a90a5e6c2026-07-29WarningsExact identifier
application number: M021
Natural White Radiant WhiteFLUORIDELornamead Productsf0b62aaa-4983-4bd3-931e-f1a31b870f622026-07-29WarningsExact identifier
application number: M021
TP OW Pro Series Stain PreventionSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company76df52a3-b24c-4009-8137-fe644dabebf62026-07-29WarningsExact identifier
application number: M021
Colgate Kids Cavity ProtectionSODIUM FLUORIDEColgate-Palmolive Companyf0e68196-8566-443b-9cc8-b57d5c0015582026-07-29WarningsExact identifier
application number: M021
TP OW Pro Series Vividly FreshSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyf0551acf-c4d6-4d49-ae9c-4aeaeb99a7002026-07-29WarningsExact identifier
application number: M021
Colgate MaxFresh with Whitening KnockOut FluorideSODIUM FLUORIDEColgate-Palmolive Company92079d13-3b66-42b7-9990-2727a489b6f62026-07-28WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Quebec Inc. DBA Attitude7d04d050-b283-4fce-b1e9-e695b70363f92026-07-27WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE ADVANCED OXYGENATING WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companycd805999-86e4-4f6c-9889-fa9a2227d5262026-07-24WarningsExact identifier
application number: M021
COLGATE Baking Soda and Peroxide Whitening Brisk MintSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company913a2cd6-b6a8-4069-979f-3c696a9bfdf02026-07-24WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PURPLESODIUM FLUORIDEColgate-Palmolive Company16e9b303-fc2a-451a-adc7-dcb10fc0e6f82026-07-23WarningsExact identifier
application number: M021
Orajel Kids SupermanANTICAVITY TOOTHPASTEChurch & Dwight Co., Inc.2b47af33-32d4-7c06-e063-6394a90a2f332026-07-23WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN96247083-39e9-7ca7-e053-2995a90a75d010
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD96247083-39e9-7ca7-e053-2995a90a75d010
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY96247083-39e9-7ca7-e053-2995a90a75d010
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY96247083-39e9-7ca7-e053-2995a90a75d010
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY96247083-39e9-7ca7-e053-2995a90a75d010
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY96247083-39e9-7ca7-e053-2995a90a75d010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-945-02370000945022 CARTON in 1 CELLO PACK (37000-945-02) / 1 TUBE in 1 CARTON / 116 g in 1 TUBE2 carton2019-07-010000-00-00NoNoCurrent
37000-945-03370000945033 CARTON in 1 CELLO PACK (37000-945-03) / 1 TUBE in 1 CARTON / 116 g in 1 TUBE3 carton2019-07-010000-00-00NoNoCurrent
37000-945-27370000945271 TUBE in 1 CARTON (37000-945-27) / 76 g in 1 TUBE1 tube2019-07-01NoNoCurrent
37000-945-30370000945301 TUBE in 1 CARTON (37000-945-30) / 85 g in 1 TUBE1 tube2019-07-010000-00-00NoNoCurrent
37000-945-38370000945381 TUBE in 1 CARTON (37000-945-38) / 108 g in 1 TUBE1 tube2019-07-01NoNoCurrent
37000-945-41370000945411 TUBE in 1 CARTON (37000-945-41) / 116 g in 1 TUBE1 tube2019-07-020000-00-00NoNoCurrent
37000-945-76370000945762 CARTON in 1 CELLO PACK (37000-945-76) / 1 TUBE in 1 CARTON / 108 g in 1 TUBE2 carton2019-07-01NoNoCurrent
37000-945-82370000945822 TUBE in 1 CARTON (37000-945-82) / 116 g in 1 TUBE2 tube2020-01-010000-00-00NoNoCurrent