FDA.reportPublic FDA data

Crest 3D White

Product NDC
69423-836
11-digit product format
694230836
Labeler code
69423
Product ID
69423-836_47e5179c-5fa2-860c-e063-6294a90a6462
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Procter & Gamble Manfuacturing Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-01
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 3D White
Brand name suffix
Advanced Deep Clean
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
128613c4-c06b-bdf5-e063-6294a90acd34Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-836-23Crest 3D WhiteAdvanced Deep Clean93 g in 1 TUBEPASTE, DENTIFRICE936
69423-836-23Crest 3D WhiteAdvanced Deep Clean2 in 1 CARTONPASTE, DENTIFRICE26
69423-836-28Crest 3D WhiteAdvanced Deep Clean107 g in 1 TUBEPASTE, DENTIFRICE1076
69423-836-28Crest 3D WhiteAdvanced Deep Clean2 in 1 CARTONPASTE, DENTIFRICE26
69423-836-33Crest 3D WhiteAdvanced Deep Clean1 in 1 CARTONPASTE, DENTIFRICE16
69423-836-33Crest 3D WhiteAdvanced Deep Clean93 g in 1 TUBEPASTE, DENTIFRICE936
69423-836-38Crest 3D WhiteAdvanced Deep Clean107 g in 1 TUBEPASTE, DENTIFRICE1076
69423-836-38Crest 3D WhiteAdvanced Deep Clean1 in 1 CARTONPASTE, DENTIFRICE16
69423-836-66Crest 3D WhiteAdvanced Deep Clean1 in 1 CARTONPASTE, DENTIFRICE16
69423-836-66Crest 3D WhiteAdvanced Deep Clean187 g in 1 TUBEPASTE, DENTIFRICE1876

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-836CREST 3D WHITE ADVANCED DEEP CLEAN (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANFUACTURING COMPANY]3Current NDC, 10 package rows20250116_128613c4-c06b-bdf5-e063-6294a90acd34.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 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DawnMistTOOTHPASTEDukal LLC147f7738-5080-9907-e063-6294a90a61702025-02-07WarningsExact identifier
application number: M021
DawnMist Gel FluorideGEL FLUORIDE TOOTHPASTEDukal LLC14443184-1694-70b9-e063-6394a90a86fe2025-02-07WarningsExact identifier
application number: M021
Quip Anticavity Fluoride ConcentrateSODIUM FLUORIDEQuip NYC Inc.b3da65bb-0871-34e7-e053-2a95a90a310e2025-01-30WarningsExact identifier
application number: M021
Quip AnticavitySODIUM FLUORIDEQuip NYC Inc.b6d4cfe3-535e-9163-e053-2a95a90ae1402025-01-30WarningsExact identifier
application number: M021
Quip AnticavitySODIUM FLUORIDEQuip NYC Inc.b6d8a9b6-1fdd-6a54-e053-2995a90a2c1a2025-01-30WarningsExact identifier
application number: M021
QuipSODIUM FLUORIDEQuip NYC Inc.714b7205-444d-929b-e053-2995a90a958e2025-01-30WarningsExact identifier
application number: M021
Cool sense Care PlusSODIUM FLUORIDEDOCSMEDI Co., Ltd.ea18ac56-4ef1-4bf0-8c26-6885183fd6842025-01-22WarningsExact identifier
application number: M021
DOCTRUST DOUBLEX ToothSODIUM FLUORIDEDOCSMEDI Co., Ltd.aaf08481-a2ff-48f6-8611-73a469efe1db2025-01-22WarningsExact identifier
application number: M021
Double X CONCENTRATEDCETYLPYRIDINIUM CHLORIDEDOCSMEDI Co., Ltd.411be334-364c-4074-8d0b-8dda332f87de2025-01-22WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Quebec Inc. DBA Attituded33e3778-ba1d-4560-bafa-74f7ab88c6b52025-01-20WarningsExact identifier
application number: M021
AMERFRESH FLUORIDE gelSODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTD86279b4d-82e5-45b5-9ba7-94fe3620b8502025-01-16WarningsExact identifier
application number: M021
AMERFRESH FLUORIDESODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTD827e45bb-84c0-48ee-a60b-2cc32b8f33e32025-01-16WarningsExact identifier
application number: M021
Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel ToothSODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTDbb93fb1a-885a-4d2a-a1c2-3b37bc305d572025-01-16WarningsExact identifier
application number: M021
MedprideSODIUM MONOFLUOROPHOSPHATEShield Line LLC9c1b0420-6b57-4914-99fe-df6a494815c32025-01-16WarningsExact identifier
application number: M021
Sodium FluorideSODIUM FLUORIDESafco Dental Supply LLC7a295974-c400-4442-9149-138a805ffb202025-01-09WarningsExact identifier
application number: M021
SaliveaFLUORIDE TOOTHPASTELaclede, Inc.6398ae96-dd38-44da-bc34-1d4d4c4a78ca2025-01-08WarningsExact identifier
application number: M021
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDETai Guk Pharm. Co., Ltd.098a29d5-3836-d362-e063-6394a90a9fea2025-01-01WarningsExact identifier
application number: M021
PERIOE POP Sensitivity Care Prebiotic Clean MintSTANNOUS FLUORIDETai Guk Pharm. Co., Ltd.f4ef8ee7-7197-b3dc-e053-2a95a90a1c1b2025-01-01WarningsExact identifier
application number: M021
PERIOE Microbiome Sensitive Clean MintSTANNOUS FLUORIDETai Guk Pharm. Co., Ltd.dec29c9f-6ddb-0b4e-e053-2995a90a64b12025-01-01WarningsExact identifier
application number: M021
AVON Whitening Essentials Original Cool MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.8e5de76b-535a-9c95-e053-2995a90afcab2025-01-01WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN128613c4-c06b-bdf5-e063-6294a90acd346
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD128613c4-c06b-bdf5-e063-6294a90acd346
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY128613c4-c06b-bdf5-e063-6294a90acd346
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY128613c4-c06b-bdf5-e063-6294a90acd346
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY128613c4-c06b-bdf5-e063-6294a90acd346
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY128613c4-c06b-bdf5-e063-6294a90acd346

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69423-836-23694230836232 TUBE in 1 CARTON (69423-836-23) / 93 g in 1 TUBE2 tube2019-07-01NoNoCurrent
69423-836-28694230836282 TUBE in 1 CARTON (69423-836-28) / 107 g in 1 TUBE2 tube2019-07-01NoNoCurrent
69423-836-33694230836331 TUBE in 1 CARTON (69423-836-33) / 93 g in 1 TUBE1 tube2019-07-01NoNoCurrent
69423-836-38694230836381 TUBE in 1 CARTON (69423-836-38) / 107 g in 1 TUBE1 tube2019-07-01NoNoCurrent
69423-836-66694230836661 TUBE in 1 CARTON (69423-836-66) / 187 g in 1 TUBE1 tube2025-04-01NoNoCurrent