FDA.reportPublic FDA data

Crest Premium Plus

Product NDC
37000-993
11-digit product format
370000993
Labeler code
37000
Product ID
37000-993_47e343c9-2e62-c288-e063-6394a90a0b5c
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 packagepackage37000-99337000-993-35DDiscontinued by firm2026-10-05

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 · 12 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 2025-12-0537000-993-35d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2637000-993-35f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3137000-993-522ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2837000-993-52a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2137000-993-52cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1037000-993-52cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3137000-993-52302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2037000-993-52ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1037000-993-520efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0837000-993-52ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0337000-993-52367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0937000-993-52557ba5c1ecfa…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
Advanced Whitening 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
b81a22dc-b759-24cd-e053-2995a90a9148Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
37000-993-522023-03-31Crest Premium Plus Advanced Whitening Active Foam
37000-993-522023-03-31Crest Premium Plus Advanced Whitening Active Foam
37000-993-722023-03-31Crest Premium Plus Advanced Whitening Active Foam
37000-993-722023-03-31Crest Premium Plus Advanced Whitening Active Foam
37000-993-522023-01-30Crest Premium Plus Advanced Whitening Active Foam
37000-993-522023-01-30Crest Premium Plus Advanced Whitening Active Foam
37000-993-722023-01-30Crest Premium Plus Advanced Whitening Active Foam
37000-993-722023-01-30Crest Premium Plus Advanced Whitening Active Foam

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-993-35Crest Premium PlusAdvanced Whitening Active Foam3 in 1 CARTONPASTE, DENTIFRICE312
37000-993-35Crest Premium PlusAdvanced Whitening Active Foam147 g in 1 TUBEPASTE, DENTIFRICE14712
37000-993-52Crest Premium PlusAdvanced Whitening Active Foam147 g in 1 TUBEPASTE, DENTIFRICE14712
37000-993-52Crest Premium PlusAdvanced Whitening Active Foam1 in 1 CARTONPASTE, DENTIFRICE112
37000-993-72Crest Premium PlusAdvanced Whitening Active Foam1 in 1 CARTONPASTE, DENTIFRICE112
37000-993-72Crest Premium PlusAdvanced Whitening Active Foam204 g in 1 TUBEPASTE, DENTIFRICE20412

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-993CREST PREMIUM PLUS ADVANCED WHITENING ACTIVE FOAM (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]10Current NDC, Legacy NDC, 6 package rows20250115_b81a22dc-b759-24cd-e053-2995a90a9148.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 9 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Restore and DefendSTANNOUS FLUORIDEWalgreense808ea4b-9081-085b-e053-2a95a90a4f9b2026-06-02WarningsExact identifier
application number: M021
Hello Unicorn Splash unicorn splash anticavity fluoride rinseSODIUM FLUORIDEColgate-Palmolive Companya1014431-7d23-aaff-6dc7-ab58683d03382026-06-02WarningsExact identifier
application number: M021
Therabreath AnticavitySODIUM FLUORIDEChurch & Dwight Co., Inc.feab3d45-ff95-4b32-8258-7d932a7380c92026-06-01WarningsExact identifier
application number: M021
Orajel Toy Story 5 AnticavitySODIUM FLUORIDEChurch & Dwight Co., Inc.4b80947d-f389-2f80-e063-6294a90abd552026-06-01WarningsExact identifier
application number: M021
Arm and HammerSODIUM FLUORIDEChurch & Dwight Co., Inc.54113245-0c1e-739e-e063-6294a90aea422026-06-01WarningsExact identifier
application number: M021
Arm and HammerSODIUM FLUORIDEChurch & Dwight Co., Inc.545258fd-8179-fffc-e063-6394a90a467f2026-06-01WarningsExact identifier
application number: M021
Orajel Paw PatrolSODIUM FLUORIDEChurch & Dwight Co., Inc.99d87bea-3e99-5d04-e053-2a95a90aaf542026-06-01WarningsExact identifier
application number: M021
Orajel SuperMarioANTICAVITY TOOTHPASTEChurch & Dwight Co., Inc.27d2f6cb-8661-da9c-e063-6394a90a5bde2026-06-01WarningsExact identifier
application number: M021
Orajel KidsToothpasteSODIUM FLUORIDEChurch & Dwight Co., Inc.99d62125-c2c5-5926-e053-2995a90aaa292026-06-01WarningsExact identifier
application number: M021
AIM CAVITY PROTECTION Multi BenefitSODIUM FLUORIDEChurch & Dwight Co., Inc.1d0f8a33-0b01-40e2-e054-00144ff88e882026-06-01WarningsExact identifier
application number: M021
Crest plus Tartar Protection WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company560980ea-749f-593d-e063-6394a90a1b9e2026-06-01WarningsExact identifier
application number: M021
Colgate Revitalizing WhiteSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyc67223ae-b068-41c5-a15b-7ae9840b93ef2026-05-27WarningsExact identifier
application number: M021
Colgate Kids Harry PotterSODIUM FLUORIDEColgate-Palmolive Company61c06da4-9f02-4fbc-b80f-1c443e2984962026-05-26WarningsExact identifier
application number: M021
sodium fluoride rinseSODIUM FLUORIDE RINSERockland Cosmetics, Inc.52430b12-4d5f-d1e1-e063-6394a90abd642026-05-20Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEH E Bd0a52519-3339-40ea-93e5-78f76d348a4d2026-05-14Warnings, Adverse reactionsExact identifier
application number: M021
Burts Bees Extra WhiteSODIUM FLUORIDEProcter & Gamble Manufacturing Companyc92524fd-8b93-592d-e053-2a95a90a88c62026-05-13WarningsExact identifier
application number: M021
MIPaste Plus StrawberrySODIUM FLUORIDEGC America Inc.1b68bd67-65d3-4c64-e054-00144ff8d46c2026-05-12WarningsExact identifier
application number: M021
White Glo Purple Color Corrector Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inc6f8b77c3-9833-4c75-b41c-a2bc126161572026-05-12WarningsExact identifier
application number: M021
botalab HERBAL COMPLETE TOOTHSODIUM FLUORIDEKMPHARMACEUTICAL CO., LTD.51365ef7-ed94-2650-e063-6394a90ab89e2026-05-07WarningsExact identifier
application number: M021
Morning Fresh Mint Toothpaste, with FluorideMORNING FRESH MINT TOOTHPASTE, WITH FLUORIDEDynarex Corporation2a42d8ce-e7f2-caa5-e063-6294a90ac01f2026-05-07WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSNb81a22dc-b759-24cd-e053-2995a90a914812
891775sodium fluoride 0.00243 MG/MG ToothpasteSCDb81a22dc-b759-24cd-e053-2995a90a914812
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSYb81a22dc-b759-24cd-e053-2995a90a914812
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSYb81a22dc-b759-24cd-e053-2995a90a914812
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSYb81a22dc-b759-24cd-e053-2995a90a914812
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSYb81a22dc-b759-24cd-e053-2995a90a914812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-993-35370000993353 in 1 CARTONHistorical
37000-993-52370000993521 TUBE in 1 CARTON (37000-993-52) / 147 g in 1 TUBE1 tube2021-01-010000-00-00NoNoCurrent
37000-993-72370000993721 TUBE in 1 CARTON (37000-993-72) / 204 g in 1 TUBE1 tube2021-01-010000-00-00NoNoCurrent