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 40 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WHITE GLO PROFESSIONAL CHOICESODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC13314c9a-de93-4f54-b703-b5cebdf1e6aa2025-02-26WarningsExact identifier
application number: M021
WHITE GLO CHARCOALSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCa14bb838-f07a-3a6f-e053-2995a90a535d2025-02-26WarningsExact identifier
application number: M021
White Glo Maximum White CharcoalSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCce4f64d2-969f-7ac1-e053-2995a90a627b2025-02-26WarningsExact identifier
application number: M021
White Glo Instant WhiteSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCce4f0f8f-46f0-b4e6-e053-2a95a90af6c62025-02-26WarningsExact identifier
application number: M021
White Glo Instant White Blue Foam Optical Enhancers Fluoride Anticavity Value 2 pack and ToothbrushSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC7c15eedb-d4ca-4fc1-8a1e-6f9cad0cc1262025-02-26WarningsExact identifier
application number: M021
White Glo Mouthwash ProtectionSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCce4f0f8f-46f1-b4e6-e053-2a95a90af6c62025-02-26WarningsExact identifier
application number: M021
White Glo Professional White AntiCavitySODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC1fb04108-31b3-43dd-9509-bfa8461135162025-02-26WarningsExact identifier
application number: M021
White Glo Activated Charcoal Twin PackSODIUM FLUORIDEWHITE GLO USA INC6adaca4f-5599-41e0-9215-c7ee5c1dc3722025-02-26WarningsExact identifier
application number: M021
White Glo Professional Choice Twin PackSODIUM FLUORIDEWHITE GLO USA INC0c913e38-e655-7208-e063-6294a90a58c92025-02-26WarningsExact identifier
application number: M021
White Glo Advantage Anticavity Fluoride PurpleSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCb25aa35b-98ce-4605-a7b1-8c2fe476e1a82025-02-26WarningsExact identifier
application number: M021
White Glo Coffee and Tea Stain Remover Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCd69387f9-03b8-4551-a814-20606500af282025-02-26WarningsExact identifier
application number: M021
White Glo Advantage Anticavity Professional WhiteningSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC164c3e87-74e5-4128-9bd7-60e162e589842025-02-26WarningsExact identifier
application number: M021
Listerine Total Care Kids Anticavity Fluoride Rinse Mint ShieldSODIUM FLUORIDEKenvue Brands LLC2e01b69a-b8f7-f2b9-e063-6294a90af3882025-02-13WarningsExact identifier
application number: M021
Listerine Total Care Kids Anticavity Fluoride Rinse Bubble BlastSODIUM FLUORIDEKenvue Brands LLC2e021015-bb43-482b-e063-6294a90a69022025-02-13WarningsExact identifier
application number: M021
ZONSEN Gel FluorideGEL FLUORIDE TOOTHPASTEWuhan Zonsen Medical Products Co., Ltd.2c1e40c9-8314-46ac-e063-6294a90a84ba2025-02-11WarningsExact identifier
application number: M021
ZONSEN Toothpaste,whiteTOOTHPASTEWuhan Zonsen Medical Products Co., Ltd.2c3349bf-710b-fb84-e063-6394a90a3cc72025-02-11WarningsExact identifier
application number: M021
DawnMistTOOTHPASTEDukal LLC147f7738-5080-9907-e063-6294a90a61702025-02-07WarningsExact identifier
application number: M021
DawnMist Gel FluorideGEL FLUORIDE TOOTHPASTEDukal LLC14443184-1694-70b9-e063-6394a90a86fe2025-02-07WarningsExact identifier
application number: M021
Quip Anticavity Fluoride ConcentrateSODIUM FLUORIDEQuip NYC Inc.b3da65bb-0871-34e7-e053-2a95a90a310e2025-01-30WarningsExact identifier
application number: M021
Quip AnticavitySODIUM FLUORIDEQuip NYC Inc.b6d4cfe3-535e-9163-e053-2a95a90ae1402025-01-30WarningsExact 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