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 44 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Total SF Clean MintSTANNOUS FLUORIDEColgate-Palmolive Company8e79e33c-88d3-afc2-e5a2-c6ad55db0dc02024-10-02WarningsExact identifier
application number: M021
Colgate Total SF Whitening CharcoalSTANNOUS FLUORIDEColgate-Palmolive Company36cd9cfc-7390-4400-8ede-b9d172d839532024-10-02WarningsExact identifier
application number: M021
Colgate Total SF Deep CleanSTANNOUS FLUORIDEColgate-Palmolive Company85e83b72-2d09-aec0-db7e-6b5715c5a86c2024-10-01WarningsExact identifier
application number: M021
Colgate Total SF Advanced WhiteningSTANNOUS FLUORIDEColgate-Palmolive Companycef9a30c-a18c-47e9-b276-f56608f0400f2024-10-01WarningsExact identifier
application number: M021
Colgate Total SF WhiteningSTANNOUS FLUORIDEColgate-Palmolive Company86c4b51e-b086-4566-8f94-a951bf0c62542024-09-30WarningsExact identifier
application number: M021
Colgate Total Whitening Fresh BoostSTANNOUS FLUORIDEColgate-Palmolive Companyc436382e-2755-c882-2970-4be1b9ca537b2024-09-30WarningsExact identifier
application number: M021
Colgate Total SF Whitening GelSTANNOUS FLUORIDEColgate-Palmolive Company27c4eed5-9121-4e09-9d42-e0a3e84301092024-09-30WarningsExact identifier
application number: M021
Colgate Total Whitening CharcoalSTANNOUS FLUORIDEColgate-Palmolive Company56434e3d-ba0a-8b42-6c97-0d00556067932024-09-30WarningsExact identifier
application number: M021
Colgate Total SF Mint Stripe GelSTANNOUS FLUORIDEColgate-Palmolive Companyabfbcacd-9c1a-4472-9e91-a85e78050a9e2024-09-30WarningsExact identifier
application number: M021
Colgate Total SF Advanced WhiteningSTANNOUS FLUORIDEColgate-Palmolive Companyf8aeac8e-6a3e-4ada-bb13-db337b934ba32024-09-27WarningsExact identifier
application number: M021
OCEAN FRIENDS ANTICAVITY FLUORIDE WATERMELON FLAVORSODIUM FLUORIDECVS Pharmacy, Inc.4a68bd30-91d3-46c9-a3d4-4fe342b5e6ef2024-09-27WarningsExact identifier
application number: M021
Colgate Total SF Advanced Deep CleanSTANNOUS FLUORIDEColgate-Palmolive Company92642408-4465-4f8f-85f9-cf12aadc147b2024-09-27WarningsExact identifier
application number: M021
Brush Buddies SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FLAVORSODIUM FLUORIDEAshtel Studios Inc.b197ac2d-f9d6-4937-a0a6-2f425e4c37962024-09-26WarningsExact identifier
application number: M021
Brush Buddies SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FLAVORSODIUM FLUORIDEAshtel Studios, Incdc04ee5c-3561-4579-8f9b-00266a8c88712024-09-25WarningsExact identifier
application number: M021
Made by Dentists For Kids Cheetah Dust (Strawberry)SODIUM FLUORIDEMADE BY DENTISTS INC94939abe-b05e-4ea2-a1a6-204da857b4aa2024-09-18WarningsExact identifier
application number: M021
ACT Anticavity Fluoride Arctic BlastSODIUM FLUORIDEChattem, Inc.2d5c1ce7-3c3e-415e-9469-a8d3ddfe2c572024-08-22WarningsExact identifier
application number: M021
CinnaFreshSODIUM FLUORIDEBob Barker Company Inc.3fbd95f0-a10c-4351-ad80-7e90b2d6a6f52024-08-22WarningsExact identifier
application number: M021
Karl and Hans Botanic Double MintSODIUM MONOFLUOROPHOSPHATEPIGEON CORPORATIONd1233fc3-047c-4e26-bb2b-8ebde09c05a92024-08-08WarningsExact identifier
application number: M021
Karl and Hans Botanic JasmineSODIUM MONOFLUOROPHOSPHATEPIGEON CORPORATION6c0335e6-f041-48c7-9da3-88c124b84b002024-08-08WarningsExact identifier
application number: M021
OMNISTANNOUS FLUORIDESolventum US LLC0c2a81b1-65b5-432b-8e66-30432a245aba2024-08-01WarningsExact 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