FDA.reportPublic FDA data

Crest Complete Multi Benefit

Product NDC
37000-504
11-digit product format
370000504
Labeler code
37000
Product ID
37000-504_47e4b95e-c57c-68eb-e063-6394a90a18da
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
2009-09-08
Substance
SODIUM FLUORIDE
Active strength
1.5 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 10 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage37000-50437000-504-05DDiscontinued by firm2026-10-12
excluded packagepackage37000-50437000-504-12DDiscontinued by firm2026-10-12
excluded packagepackage37000-50437000-504-40DDiscontinued by firm2026-10-12
excluded packagepackage37000-50437000-504-48DDiscontinued by firm2026-10-12
excluded packagepackage37000-50437000-504-58DDiscontinued by firm2026-10-12
excluded packagepackage37000-50437000-504-73DDiscontinued by firm2026-10-12
excluded packagepackage37000-50437000-504-76DDiscontinued by firm2026-10-12
excluded packagepackage37000-50437000-504-80DDiscontinued by firm2026-10-12
excluded packagepackage37000-50437000-504-98DDiscontinued by firm2026-10-12
excluded packagepackage37000-50437000-504-99DDiscontinued by firm2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0537000-504-76d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0537000-504-12d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2637000-504-76f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2637000-504-12f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3137000-504-122ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3137000-504-762ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2837000-504-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2837000-504-76a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2137000-504-12cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2137000-504-76cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1037000-504-12cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1037000-504-76cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3137000-504-12302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3137000-504-76302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2037000-504-12ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2037000-504-76ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1037000-504-120efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1037000-504-760efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0837000-504-12ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0837000-504-76ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0337000-504-12367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0337000-504-76367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0937000-504-12557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0937000-504-76557ba5c1ecfa…9c80585c8c6e…

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 Multi Benefit
Brand name suffix
Whitening plus Scope Outlast
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
66c41b24-d394-6609-e053-2a91aa0a0a2cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-504-05Crest Complete Multi BenefitWhitening plus Scope Outlast5 in 1 CELLO PACKPASTE, DENTIFRICE512
37000-504-05Crest Complete Multi BenefitWhitening plus Scope Outlast1 in 1 CARTONPASTE, DENTIFRICE112
37000-504-12Crest Complete Multi BenefitWhitening plus Scope Outlast164 g in 1 TUBEPASTE, DENTIFRICE16412
37000-504-12Crest Complete Multi BenefitWhitening plus Scope Outlast2 in 1 CARTONPASTE, DENTIFRICE212
37000-504-40Crest Complete Multi BenefitWhitening plus Scope Outlast1 in 1 CARTONPASTE, DENTIFRICE112
37000-504-40Crest Complete Multi BenefitWhitening plus Scope Outlast113 g in 1 TUBEPASTE, DENTIFRICE11312
37000-504-48Crest Complete Multi BenefitWhitening plus Scope Outlast136 g in 1 TUBEPASTE, DENTIFRICE13612
37000-504-48Crest Complete Multi BenefitWhitening plus Scope Outlast1 in 1 CARTONPASTE, DENTIFRICE112
37000-504-54Crest Complete Multi BenefitWhitening plus Scope Outlast1 in 1 CARTONPASTE, DENTIFRICE112
37000-504-54Crest Complete Multi BenefitWhitening plus Scope Outlast153 g in 1 TUBEPASTE, DENTIFRICE15312
37000-504-58Crest Complete Multi BenefitWhitening plus Scope Outlast164 g in 1 TUBEPASTE, DENTIFRICE16412
37000-504-58Crest Complete Multi BenefitWhitening plus Scope Outlast1 in 1 CARTONPASTE, DENTIFRICE112
37000-504-73Crest Complete Multi BenefitWhitening plus Scope Outlast206 g in 1 TUBEPASTE, DENTIFRICE20612
37000-504-73Crest Complete Multi BenefitWhitening plus Scope Outlast1 in 1 CARTONPASTE, DENTIFRICE112
37000-504-76Crest Complete Multi BenefitWhitening plus Scope Outlast215 g in 1 TUBEPASTE, DENTIFRICE21512
37000-504-76Crest Complete Multi BenefitWhitening plus Scope Outlast1 in 1 CARTONPASTE, DENTIFRICE112
37000-504-80Crest Complete Multi BenefitWhitening plus Scope Outlast226 g in 1 TUBEPASTE, DENTIFRICE22612
37000-504-80Crest Complete Multi BenefitWhitening plus Scope Outlast1 in 1 CARTONPASTE, DENTIFRICE112
37000-504-98Crest Complete Multi BenefitWhitening plus Scope Outlast2 in 1 CARTONPASTE, DENTIFRICE212
37000-504-98Crest Complete Multi BenefitWhitening plus Scope Outlast153 g in 1 TUBEPASTE, DENTIFRICE15312
37000-504-99Crest Complete Multi BenefitWhitening plus Scope Outlast3 in 1 CELLO PACKPASTE, DENTIFRICE312
37000-504-99Crest Complete Multi BenefitWhitening plus Scope Outlast1 in 1 CARTONPASTE, DENTIFRICE112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-504CREST COMPLETE MULTI BENEFIT WHITENING PLUS SCOPE OUTLAST (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]9Current NDC, Legacy NDC, 22 package rows20250110_66c41b24-d394-6609-e053-2a91aa0a0a2c.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 5 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sensitive Teeth and GumsPOTASSIUM NITRATE, SODIUM FLUORIDEChurch & Dwight Co., Inc.935172db-d78f-0c69-e053-2a95a90a0b692026-07-23WarningsExact identifier
application number: M021
Essentials Whiten and StrengthenSODIUM FLUORIDE 0.24%Church & Dwight Co., Inc.96548550-2cd1-b757-e053-2995a90a15ea2026-07-23WarningsExact identifier
application number: M021
TP COL OW PurpleSODIUM FLUORIDEColgate-Palmolive Companyea0db59f-f9c0-49a8-9717-69cdf071f6e12026-07-23WarningsExact identifier
application number: M021
Colgate Max Fresh Cool MintSODIUM FLUORIDEColgate-Palmolive Company00652bb2-090c-4eaa-8fc2-e0be6913a7242026-07-22WarningsExact identifier
application number: M021
Colgate Ultra White CharcoalSODIUM FLUORIDEColgate-Palmolive Company95d06fcc-f56d-43f1-924a-3f91fda59bdf2026-07-22WarningsExact identifier
application number: M021
COLGATE Great Regular FlavorSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company730f40f6-6ac6-49bd-888b-c0b5818a03c82026-07-20WarningsExact identifier
application number: M021
COLGATE KPOP DEMON HUNTERS BUBBLE POPSODIUM FLUORIDEColgate-Palmolive Companybf465181-01e9-44ca-91f8-03110a6067742026-07-16WarningsExact identifier
application number: M021
Colgate Minions Mild Bubble Fruit FluorideSODIUM FLUORIDEColgate-Palmolive Company16634b99-f305-48bf-ac54-a9f53797a9e52026-07-16WarningsExact identifier
application number: M021
Freshen Up Holiday mintSODIUM FLUORIDEDabur India Limited56aaa9f5-7eac-11d9-e063-6294a90af3a82026-07-15WarningsExact identifier
application number: M021
Freshen Up pepper mintSODIUM FLUORIDEDabur India Limited56aaba60-523e-6ac7-e063-6394a90a27562026-07-15WarningsExact identifier
application number: M021
Freshen-up Matcha MintSODIUM FLUORIDEDabur India Limited56aac050-73e7-298c-e063-6294a90a26eb2026-07-15WarningsExact identifier
application number: M021
Freshen Up twisted peppermintSODIUM FLUORIDEDabur India Limited56aac7a7-c086-2fa5-e063-6294a90aa9592026-07-15WarningsExact identifier
application number: M021
Freshen Up Vanilla MintSODIUM FLUORIDEDabur India Limited56aad223-db88-7cf6-e063-6394a90a6b722026-07-15WarningsExact identifier
application number: M021
Freshen UpSODIUM FLUORIDEMKJ BRANDS LLC2dcd4816-caa5-c006-e063-6394a90ac4872026-07-15WarningsExact identifier
application number: M021
Freshen UpSODIUM FLUORIDEDABUR INDIA LIMITED56acecd2-6966-2ee4-e063-6394a90a356f2026-07-15WarningsExact identifier
application number: M021
Colgate Max Fresh Advanced WhiteningSODIUM FLUORIDEColgate-Palmolive Company01c07c25-2748-4d90-9505-094e2c977c9c2026-07-15WarningsExact identifier
application number: M021
Crest StrawberrySODIUM FLUORIDEThe Procter & Gamble Manufacturing Company7d51c67b-7409-e5a7-e053-2a91aa0a81fa2026-07-14WarningsExact identifier
application number: M021
Freshen UpSODIUM FLUORIDE, POTASSIUM NITRATEMKJ BRANDS LLC476f453b-9215-0a11-e063-6294a90a5cd42026-07-14WarningsExact identifier
application number: M021
Freshen Up Vanilla MintSODIUM FLUORIDEMKJ BRANDS LLC525662da-42be-eaa6-e063-6294a90af1102026-07-14WarningsExact identifier
application number: M021
Freshen Up twisted peppermintSODIUM FLUORIDEMKJ BRANDS LLC526acbdd-6531-692d-e063-6394a90ab9f12026-07-14WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN66c41b24-d394-6609-e053-2a91aa0a0a2c12
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD66c41b24-d394-6609-e053-2a91aa0a0a2c12
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY66c41b24-d394-6609-e053-2a91aa0a0a2c12
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY66c41b24-d394-6609-e053-2a91aa0a0a2c12
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY66c41b24-d394-6609-e053-2a91aa0a0a2c12
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY66c41b24-d394-6609-e053-2a91aa0a0a2c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-504-05370000504055 CARTON in 1 CELLO PACK (37000-504-05) > 1 TUBE in 1 CARTON > 206 g in 1 TUBE5 carton2009-09-082021-12-31NoNoCurrent
37000-504-1237000050412164 g in 1 TUBE164 gHistorical
37000-504-40370000504401 TUBE in 1 CARTON (37000-504-40) > 113 g in 1 TUBE1 tube2009-09-082021-12-31NoNoCurrent
37000-504-48370000504481 TUBE in 1 CARTON (37000-504-48) > 136 g in 1 TUBE1 tube2009-09-080000-00-00NoNoCurrent
37000-504-54370000504541 TUBE in 1 CARTON (37000-504-54) / 153 g in 1 TUBE1 tube2019-01-012021-12-31NoNoCurrent
37000-504-58370000504581 TUBE in 1 CARTON (37000-504-58) > 164 g in 1 TUBE1 tube2009-09-080000-00-00NoNoCurrent
37000-504-73370000504731 TUBE in 1 CARTON (37000-504-73) > 206 g in 1 TUBE1 tube2009-09-080000-00-00NoNoCurrent
37000-504-7637000050476215 g in 1 TUBE215 gHistorical
37000-504-80370000504801 TUBE in 1 CARTON (37000-504-80) > 226 g in 1 TUBE1 tube2019-01-012021-12-31NoNoCurrent
37000-504-98370000504982 TUBE in 1 CARTON (37000-504-98) > 153 g in 1 TUBE2 tube2019-01-012021-12-31NoNoCurrent
37000-504-99370000504993 CARTON in 1 CELLO PACK (37000-504-99) > 1 TUBE in 1 CARTON > 153 g in 1 TUBE3 carton2019-01-012021-12-31NoNoCurrent