FDA.reportPublic FDA data

Crest 3D White Advanced

Product NDC
69423-752
11-digit product format
694230752
Labeler code
69423
Product ID
69423-752_47e28597-136d-217d-e063-6294a90a2cec
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium monofluorophosphate
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-10
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1.7 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 3D White Advanced
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE1.7 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C810JCZ56QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038995Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f3aa9a59-b4d4-05d9-e053-2995a90a0aeaAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-752-23Crest 3D White Advanced65 g in 1 TUBEPASTE, DENTIFRICE656
69423-752-23Crest 3D White Advanced1 in 1 CARTONPASTE, DENTIFRICE16
69423-752-30Crest 3D White Advanced85 g in 1 TUBEPASTE, DENTIFRICE856
69423-752-30Crest 3D White Advanced1 in 1 CARTONPASTE, DENTIFRICE16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-752CREST 3D WHITE ADVANCED (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]5Current NDC, 4 package rows20250115_f3aa9a59-b4d4-05d9-e053-2995a90a0aea.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 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IoliteBENZOCAINEDharma Research, Inc.e4b2d22b-00b3-45a6-9b7d-8ee7195870592023-10-09WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.a0e284f6-292f-4231-8596-f7cee4e0a12f2023-10-09WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCfe92637a-c88a-f9dd-e053-6294a90a7fa32023-07-01WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCc979e958-2042-471a-bf03-e84e686201062023-06-20WarningsExact identifier
application number: M022
Orajel Gum Pain 3X MedicatedBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.9a1632ad-2b47-5653-e053-2995a90ae0d92023-01-20WarningsExact identifier
application number: M022
KOLORZ TOPICAL ANESTHETIC TRIPLE MINTBENZOCAINEDMG AMERICA, LLC0f90b227-f938-4e1a-a79e-1967b1a0477e2021-10-01WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038995sodium monofluorophosphate 1.14 % ToothpastePSNf3aa9a59-b4d4-05d9-e053-2995a90a0aea6
1038995sodium monofluorophosphate 0.0114 MG/MG ToothpasteSCDf3aa9a59-b4d4-05d9-e053-2995a90a0aea6
1038995sodium monofluorophosphate 1.14 % (fluoride ion 0.17 % )ToothpasteSYf3aa9a59-b4d4-05d9-e053-2995a90a0aea6
1038995sodium monofluorophosphate 1.14 % (fluoride ion 0.19 % )ToothpasteSYf3aa9a59-b4d4-05d9-e053-2995a90a0aea6
1038995sodium monofluorophosphate 1.14 % ToothpasteSYf3aa9a59-b4d4-05d9-e053-2995a90a0aea6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69423-752-23694230752231 TUBE in 1 CARTON (69423-752-23) / 65 g in 1 TUBE1 tube2023-01-10NoNoCurrent
69423-752-30694230752301 TUBE in 1 CARTON (69423-752-30) / 85 g in 1 TUBE1 tube2023-01-10NoNoCurrent