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 firm2026-10-20

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…

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 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 29 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Supersmile Professional Whitening TP Citrus BlastSODIUM MONOFLUOROPHOSPHATERobell Research, Inc25039552-c35d-a69d-e063-6394a90ab1032026-01-08WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Citrus BlastSODIUM MONOFLUOROPHOSPHATERobell Research, Inc2504686d-b053-51d0-e063-6394a90a789f2026-01-08WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Peppy Mint 8 ozSODIUM MONOFLUOROPHOSPHATERobell Research, Inc25121ebb-922b-719d-e063-6394a90a23d32026-01-08WarningsExact identifier
application number: M021
Crest Pro-health Gum Detoxify Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf498b727-c38c-1d67-e053-2995a90a0f112026-01-08WarningsExact identifier
application number: M021
DG health Sensitive Maximum StrengthPOTASSIUM NITRATE, SODIUM FLUORIDEDolgencorp, LLC81cd5d37-3751-625f-e053-2a91aa0a6dfd2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Glamorous WhiteSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf5b18988-68c7-40f9-e053-2995a90a22bc2026-01-08WarningsExact identifier
application number: M021
CVS Restore and Defend Sensitive WhiteningSTANNOUS FLUORIDECVS Pharmacy81b72da2-7f41-74ca-e053-2a91aa0a96462026-01-08WarningsExact identifier
application number: M021
Gum and Enamel RepairSTANNOUS FLUORIDECVSccad05d4-7f05-bebd-e053-2a95a90aa52c2026-01-08WarningsExact identifier
application number: M021
CVS Pharmacy Pro DefenseFLUORIDECVS Pharmacy445ec57e-dc3c-49a0-8ca9-4806fcdc03032026-01-08WarningsExact identifier
application number: M021
Gum DetoxifySTANNOUS FLUORIDEWalmartad3f645d-aaf9-2800-e053-2a95a90ab62f2026-01-08WarningsExact identifier
application number: M021
CVS Complete ProtectionSTANNOUS FLOURIDECVSb681b5e4-a0e1-8d0f-e053-2a95a90aa6722026-01-06WarningsExact identifier
application number: M021
Complete ProtectionSTANNOUS FLUORIDETarget03708e08-0189-b83d-e063-6394a90a50e62026-01-06WarningsExact identifier
application number: M021
Brush Buddies Mouthwash 12oz Star Wars Saber Strike StrawberrySODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.4998c0e6-1de3-11cd-e063-6294a90acb6f2026-01-01WarningsExact identifier
application number: M021
Exceed Total Care Sensitive Spearmint Tooth PolishPOTASSIUM NITRATE AND SODIUM FLUORIDEMelaleuca, Incdc620d3f-880f-df05-e053-2995a90a84092025-12-31WarningsExact identifier
application number: M021
Exceed Total Care Sensitive Peppermint Tooth PolishPOTASSIUM NITRATE AND SODIUM FLUORIDEMelaleuca, Inced2179a4-3d19-6481-e053-2995a90ad6552025-12-31WarningsExact identifier
application number: M021
Koala Pals BerryliciousSODIUM FLUORIDEMelaleuca, Inc.6624be86-c9a8-53b8-e053-2a91aa0a87ef2025-12-31WarningsExact identifier
application number: M021
Whitening Tooth PolishSODIUM FLUORIDEMelaleuca, Inc.6893405a-a2c4-068e-e053-2a91aa0ae5b12025-12-31WarningsExact identifier
application number: M021
Gel 1100 MintSODIUM FLUORIDEDental Alliance Holdings LLCf125fb04-5045-5367-e053-2a95a90aa73b2025-12-29WarningsExact identifier
application number: M021
Gracie Square Hospital AmenitySODIUM MONOFLUOROPHOSPHATEASP Global, LLc89d81053-6950-465e-a5b1-cbf841d7afcb2025-12-29WarningsExact identifier
application number: M021
CloSYS Fluoride RinseSODIUM FLUORIDERowpar Pharmaceuticals, Inc.1a994f24-99ee-4b27-aab0-e816931a22c82025-12-23WarningsExact 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