FDA.reportPublic FDA data

Crest Complete Multi-Benefit

Product NDC
37000-822
11-digit product format
370000822
Labeler code
37000
Product ID
37000-822_47e49920-ad71-b3f8-e063-6294a90ae9fc
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-07-01
Substance
SODIUM FLUORIDE
Active strength
1.1 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 Complete Multi-Benefit
Brand name suffix
Plus Scope
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.1 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
8c91095d-88c0-4d22-a79a-7d0f0d05302bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-05-19Crest ® complete MULTI-BENEFIT™
2023-05-19Crest ® complete MULTI-BENEFIT™
2023-05-19Crest ® complete MULTI-BENEFIT™
2023-01-30Crest ® complete MULTI-BENEFIT™
2023-01-30Crest ® complete MULTI-BENEFIT™
2023-01-30Crest ® complete MULTI-BENEFIT™
2021-02-12Crest ® complete MULTI-BENEFIT™
2021-02-12Crest ® complete MULTI-BENEFIT™
2021-02-12Crest ® complete MULTI-BENEFIT™
2021-01-29Crest ® complete MULTI-BENEFIT™
2021-01-29Crest ® complete MULTI-BENEFIT™
2021-01-29Crest ® complete MULTI-BENEFIT™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-822-04Crest Complete Multi-BenefitPlus Scope130 g in 1 BOTTLEGEL, DENTIFRICE13015

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W7CREST COMPLETE MULTI-BENEFIT PLUS SCOPE (SODIUM FLUORIDE) GEL, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]3
Fluoride IonACTIVE MOIETYQ80VPU408OCREST COMPLETE MULTI-BENEFIT PLUS SCOPE (SODIUM FLUORIDE) GEL, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]3
alcoholINACTIVE INGREDIENT3K9958V90MCREST COMPLETE MULTI-BENEFIT PLUS SCOPE (SODIUM FLUORIDE) GEL, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]3
benzoic acidINACTIVE INGREDIENT8SKN0B0MIMCREST COMPLETE MULTI-BENEFIT PLUS SCOPE (SODIUM FLUORIDE) GEL, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]3
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS311CREST COMPLETE MULTI-BENEFIT PLUS SCOPE (SODIUM FLUORIDE) GEL, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]3
cetylpyridinium chlorideINACTIVE INGREDIENTD9OM4SK49PCREST COMPLETE MULTI-BENEFIT PLUS SCOPE (SODIUM FLUORIDE) GEL, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]3
fd&c blue no. 1INACTIVE INGREDIENTH3R47K3TBDCREST COMPLETE MULTI-BENEFIT PLUS SCOPE (SODIUM FLUORIDE) GEL, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]3
fd&c yellow no. 5INACTIVE INGREDIENTI753WB2F1MCREST COMPLETE MULTI-BENEFIT PLUS SCOPE (SODIUM FLUORIDE) GEL, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]3
glycerinINACTIVE INGREDIENTPDC6A3C0OXCREST COMPLETE MULTI-BENEFIT PLUS SCOPE (SODIUM FLUORIDE) GEL, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]3
hydrated silicaINACTIVE INGREDIENTY6O7T4G8P9CREST COMPLETE MULTI-BENEFIT PLUS SCOPE (SODIUM FLUORIDE) GEL, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]3
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HCREST COMPLETE MULTI-BENEFIT PLUS SCOPE (SODIUM FLUORIDE) GEL, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]3
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TYCREST COMPLETE MULTI-BENEFIT PLUS SCOPE (SODIUM FLUORIDE) GEL, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]3
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUCREST COMPLETE MULTI-BENEFIT PLUS SCOPE (SODIUM FLUORIDE) GEL, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]3
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JCREST COMPLETE MULTI-BENEFIT PLUS SCOPE (SODIUM FLUORIDE) GEL, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]3
sodium phosphateINACTIVE INGREDIENTSE337SVY37CREST COMPLETE MULTI-BENEFIT PLUS SCOPE (SODIUM FLUORIDE) GEL, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]3
sorbitolINACTIVE INGREDIENT506T60A25RCREST COMPLETE MULTI-BENEFIT PLUS SCOPE (SODIUM FLUORIDE) GEL, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]3
waterINACTIVE INGREDIENT059QF0KO0RCREST COMPLETE MULTI-BENEFIT PLUS SCOPE (SODIUM FLUORIDE) GEL, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-822CREST COMPLETE MULTI-BENEFIT PLUS SCOPE (SODIUM FLUORIDE) GEL, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]13Current NDC, Legacy NDC, 1 package rows20250227_8c91095d-88c0-4d22-a79a-7d0f0d05302b.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 % ToothpastePSN8c91095d-88c0-4d22-a79a-7d0f0d05302b15
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD8c91095d-88c0-4d22-a79a-7d0f0d05302b15
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY8c91095d-88c0-4d22-a79a-7d0f0d05302b15
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY8c91095d-88c0-4d22-a79a-7d0f0d05302b15
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY8c91095d-88c0-4d22-a79a-7d0f0d05302b15
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY8c91095d-88c0-4d22-a79a-7d0f0d05302b15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-822-0437000082204130 g in 1 BOTTLE (37000-822-04) 130 g2011-07-010000-00-00NoNoCurrent