FDA.reportPublic FDA data

Crest complete plus

Product NDC
37000-946
11-digit product format
370000946
Labeler code
37000
Product ID
37000-946_47e3006c-545e-f700-e063-6294a90ad6c2
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
2019-08-01
Substance
SODIUM FLUORIDE
Active strength
1.4 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 complete plus
Brand name suffix
Whitening Deep Clean
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.4 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
973ce138-c64e-c059-e053-2a95a90a3148Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
37000-946-022023-03-31Crest ® complete plus Whitening Deep Clean
37000-946-542023-03-31Crest ® complete plus Whitening Deep Clean
37000-946-022023-01-30Crest ® complete plus Whitening Deep Clean
37000-946-542023-01-30Crest ® complete plus Whitening Deep Clean
37000-946-022021-02-12Crest ® complete plus Whitening Deep Clean
37000-946-542021-02-12Crest ® complete plus Whitening Deep Clean
37000-946-022021-01-29Crest ® complete plus Whitening Deep Clean
37000-946-542021-01-29Crest ® complete plus Whitening Deep Clean

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-946-02Crest complete plusWhitening Deep Clean2 in 1 CARTONPASTE, DENTIFRICE26
37000-946-02Crest complete plusWhitening Deep Clean153 g in 1 TUBEPASTE, DENTIFRICE1536
37000-946-54Crest complete plusWhitening Deep Clean153 g in 1 TUBEPASTE, DENTIFRICE1536
37000-946-54Crest complete plusWhitening Deep Clean1 in 1 CARTONPASTE, DENTIFRICE16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-946CREST COMPLETE PLUS WHITENING DEEP CLEAN (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]5Current NDC, Legacy NDC, 4 package rows20250110_973ce138-c64e-c059-e053-2a95a90a3148.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 17 of 49 · 972 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anticavity Fluoride RinseSODIUM FLUORIDECVS Pharmacy, Inc.b2f7490c-e2af-49df-b054-70fb4815f7292026-02-11Warnings, Adverse reactionsExact identifier
application number: M021
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEFORMIA LIMITEDb7d7c41e-f8b6-4e55-8acd-78eb6dda47c52026-02-09WarningsExact identifier
application number: M021
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEFORMIA LIMITED48ef2635-7157-4cd7-9f99-967f0143f7f12026-02-09WarningsExact identifier
application number: M021
Made by Dentists For Kids Eyeball Juice (Watermelon)SODIUM FLUORIDEMADE BY DENTISTS INC287887df-64de-4b5d-80e2-146c77c0fa8b2026-02-09WarningsExact identifier
application number: M021
PERIOSCIENCES White Care AO ProSODIUM FLUORIDEPERIOSCIENCES LLC092bdfa3-6267-439e-9320-e51b4805d1a12026-02-09WarningsExact identifier
application number: M021
PERIOSCIENCES HYDRATING AO ProSODIUM MONOFLUOROPHOSPHATEPERIOSCIENCES LLC5e380ca7-3d8e-4d51-a6ff-63c5a6bfe0d32026-02-09WarningsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDERetail Business Services, LLC77c066cf-f064-45d3-9732-4433165ba9ef2026-02-06Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDERetail Business Services, LLCd1c878a9-2151-4986-be09-cbab658cdd312026-02-06Warnings, Adverse reactionsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDERetail Business Services, LLC542e067a-c134-44c9-b962-f2a2b667b76f2026-02-06Warnings, Adverse reactionsExact identifier
application number: M021
Colgate 5g Toothbrush KitSODIUM MONOFLUOROPHOSPHATEWuhan Jinshengyuan Textiles Manufacturing Co., Ltd.4f0fda5e-ef42-42c3-8270-3ba614650ad12026-02-06WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDERetail Business Services, LLC3954edfd-f7f1-4218-9ee2-23f5b3661b4e2026-02-06Warnings, Adverse reactionsExact identifier
application number: M021
TheraBreath Kids Anticavity Oral Rinse BubblegumANTICAVITY ORAL RINSEChurch & Dwight Co., Inc.2770424d-7416-66d4-e063-6394a90ad4b12026-02-06WarningsExact identifier
application number: M021
Crest Pro-Health Sensitivity Whitening Plus ScopeSODIUM FLUORIDE AND POTASSIUM NITRATEThe Procter & Gamble Manufacturing Company463b7820-a5ce-f8b5-e063-6394a90aa0182026-02-05WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEPublix Super Markets, Inc.14494238-872b-49e2-8bf7-df3844a0a6c82026-02-05Warnings, Adverse reactionsExact identifier
application number: M021
HAPEE EXPLOSIVE MENTHOL RED 150SODIUM MONOFLUOROPHOSPHATELAMOIYAN CORPORATION14c14694-6149-40a8-aff2-660d39f7e0c12026-02-05WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEHARRIS TEETERf759e9e4-6de2-4b80-903b-e67c06e362952026-02-04Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDEHARRIS TEETER571f7628-fd59-462f-96dd-67aeaa98cff12026-02-04Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDELidl US, LLCc47475aa-3125-410f-aa31-0add6e4ce1252026-02-04Warnings, Adverse reactionsExact identifier
application number: M021
Crest 3D White Brilliance Pro Ultra WhiteSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Companyf4c02924-95ee-09d2-e053-2995a90a81212026-02-03Exact identifier
application number: M021
Crest 3D White Stain Eraser Icy Clean MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf5d97011-7be3-3b1c-e053-2a95a90ade862026-02-03Exact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN973ce138-c64e-c059-e053-2a95a90a31486
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD973ce138-c64e-c059-e053-2a95a90a31486
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY973ce138-c64e-c059-e053-2a95a90a31486
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY973ce138-c64e-c059-e053-2a95a90a31486
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY973ce138-c64e-c059-e053-2a95a90a31486
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY973ce138-c64e-c059-e053-2a95a90a31486

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-946-02370000946022 TUBE in 1 CARTON (37000-946-02) / 153 g in 1 TUBE2 tube2019-08-010000-00-00NoNoCurrent
37000-946-54370000946541 TUBE in 1 CARTON (37000-946-54) / 153 g in 1 TUBE1 tube2019-08-010000-00-00NoNoCurrent