FDA.reportPublic FDA data

Crest Premium Plus

Product NDC
37000-994
11-digit product format
370000994
Labeler code
37000
Product ID
37000-994_47e347f8-eb74-9c1c-e063-6294a90ab479
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
2021-01-07
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 Premium Plus
Brand name suffix
Deep Clean 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
b851fe5c-d904-12da-e053-2a95a90a86f9Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
37000-994-522024-02-06Crest Premium Plus Deep Clean Active Foam
37000-994-522024-02-06Crest Premium Plus Deep Clean Active Foam
37000-994-722024-02-06Crest Premium Plus Deep Clean Active Foam
37000-994-722024-02-06Crest Premium Plus Deep Clean Active Foam
37000-994-522024-01-30Crest Premium Plus Deep Clean Active Foam
37000-994-522024-01-30Crest Premium Plus Deep Clean Active Foam
37000-994-722024-01-30Crest Premium Plus Deep Clean Active Foam
37000-994-722024-01-30Crest Premium Plus Deep Clean Active Foam

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-994-15Crest Premium PlusDeep Clean Active Foam1 in 1 CARTONPASTE, DENTIFRICE18
37000-994-15Crest Premium PlusDeep Clean Active Foam3 in 1 CELLO PACKPASTE, DENTIFRICE38
37000-994-52Crest Premium PlusDeep Clean Active Foam147 g in 1 TUBEPASTE, DENTIFRICE1478
37000-994-52Crest Premium PlusDeep Clean Active Foam1 in 1 CARTONPASTE, DENTIFRICE18
37000-994-72Crest Premium PlusDeep Clean Active Foam1 in 1 CARTONPASTE, DENTIFRICE18
37000-994-72Crest Premium PlusDeep Clean Active Foam204 g in 1 TUBEPASTE, DENTIFRICE2048

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-994CREST PREMIUM PLUS DEEP CLEAN ACTIVE FOAM (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]6Current NDC, Legacy NDC, 6 package rows20250115_b851fe5c-d904-12da-e053-2a95a90a86f9.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 % ToothpastePSNb851fe5c-d904-12da-e053-2a95a90a86f98
891775sodium fluoride 0.00243 MG/MG ToothpasteSCDb851fe5c-d904-12da-e053-2a95a90a86f98
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSYb851fe5c-d904-12da-e053-2a95a90a86f98
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSYb851fe5c-d904-12da-e053-2a95a90a86f98
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSYb851fe5c-d904-12da-e053-2a95a90a86f98
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSYb851fe5c-d904-12da-e053-2a95a90a86f98

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-994-15370000994153 CARTON in 1 CELLO PACK (37000-994-15) / 1 TUBE in 1 CARTON / 147 g in 1 TUBE3 carton2023-01-01NoNoCurrent
37000-994-52370000994521 TUBE in 1 CARTON (37000-994-52) / 147 g in 1 TUBE1 tube2021-01-070000-00-00NoNoCurrent
37000-994-72370000994721 TUBE in 1 CARTON (37000-994-72) / 204 g in 1 TUBE1 tube2021-01-070000-00-00NoNoCurrent