FDA.reportPublic FDA data

Crest Premium Plus

Product NDC
37000-991
11-digit product format
370000991
Labeler code
37000
Product ID
37000-991_47e3398c-efde-b995-e063-6394a90a2a9b
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
2021-01-01
Substance
SODIUM FLUORIDE
Active strength
1.5 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage37000-99137000-991-04DDiscontinued by firm2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0537000-991-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2637000-991-04f5e01cc5f278…a2eaf40c39c3…
2025-02-02 03:52 UTC · source 2025-01-3137000-991-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2037000-991-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1037000-991-030efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0837000-991-03ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0337000-991-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0937000-991-03557ba5c1ecfa…9c80585c8c6e…

Additional Listing Data#

Finished product
Yes
Brand name base
Crest Premium Plus
Brand name suffix
Scope Outlast Active Foam
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
b789587e-7f49-163a-e053-2a95a90a823fAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-991-03Crest Premium PlusScope Outlast Active Foam3 in 1 CELLO PACKPASTE, DENTIFRICE313
37000-991-03Crest Premium PlusScope Outlast Active Foam1 in 1 CARTONPASTE, DENTIFRICE113
37000-991-04Crest Premium PlusScope Outlast Active Foam1 in 1 CARTONPASTE, DENTIFRICE113
37000-991-04Crest Premium PlusScope Outlast Active Foam2 in 1 CELLO PACKPASTE, DENTIFRICE213
37000-991-52Crest Premium PlusScope Outlast Active Foam147 g in 1 TUBEPASTE, DENTIFRICE14713
37000-991-52Crest Premium PlusScope Outlast Active Foam1 in 1 CARTONPASTE, DENTIFRICE113
37000-991-72Crest Premium PlusScope Outlast Active Foam204 g in 1 TUBEPASTE, DENTIFRICE20413
37000-991-72Crest Premium PlusScope Outlast Active Foam1 in 1 CARTONPASTE, DENTIFRICE113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-991CREST PREMIUM PLUS SCOPE OUTLAST ACTIVE FOAM (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]11Current NDC, Legacy NDC, 8 package rows20250309_b789587e-7f49-163a-e053-2a95a90a823f.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 52 · 1,033 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZONSENToothpasteTOOTHPASTEWuhan Zonsen Medical Products Co., Ltd.5613faef-3469-569a-e063-6394a90ac32d2026-09-10WarningsExact 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 % ToothpastePSNb789587e-7f49-163a-e053-2a95a90a823f13
891775sodium fluoride 0.00243 MG/MG ToothpasteSCDb789587e-7f49-163a-e053-2a95a90a823f13
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSYb789587e-7f49-163a-e053-2a95a90a823f13
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSYb789587e-7f49-163a-e053-2a95a90a823f13
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSYb789587e-7f49-163a-e053-2a95a90a823f13
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSYb789587e-7f49-163a-e053-2a95a90a823f13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-991-03370000991033 CARTON in 1 CELLO PACK (37000-991-03) / 1 TUBE in 1 CARTON / 147 g in 1 TUBE3 carton2021-01-010000-00-00NoNoCurrent
37000-991-04370000991041 in 1 CARTONHistorical
37000-991-52370000991521 TUBE in 1 CARTON (37000-991-52) / 147 g in 1 TUBE1 tube2021-01-010000-00-00NoNoCurrent
37000-991-72370000991721 TUBE in 1 CARTON (37000-991-72) / 204 g in 1 TUBE1 tube2021-01-010000-00-00NoNoCurrent