Colgate 5g and Toothbrush Dental Kit

Product NDC
79940-004
11-digit product format
799400004
Labeler code
79940
Product ID
79940-004_49788a32-5f1f-5e36-e063-6294a90a2f85
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
KIT
Labeler
FORMIA LIMITED
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-19
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage79940-004-00IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage79940-004-00IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage79940-004-00IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage79940-004-00IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage79940-004-00UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage79940-004-00UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage79940-004-00UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
Colgate 5g and Toothbrush Dental Kit
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
545626Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0b269f9a-aa3f-47b5-b7e8-59a5ed0e2b13Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79940-004-002025-06-23C16284748780-12cef2736-66d9-d83d-e063-dadaa90ab31fColgate 5g Toothpaste and Toothbrush Dental Kit
79940-004-002025-01-30C16284748780-12cef2736-66d9-d83d-e063-dadaa90ab31fColgate 5g Toothpaste and Toothbrush Dental Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79940-004-00Colgate 5g and Toothbrush Dental Kit1 in 1 KITKIT17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79940-004COLGATE 5G AND TOOTHBRUSH DENTAL KIT (SODIUM MONOFLUOROPHOSPHATE) KIT [FORMIA AIRLINE SUPPLIES LIMITED]4Current NDC, Legacy NDC, 1 package rows20231101_0b269f9a-aa3f-47b5-b7e8-59a5ed0e2b13.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 30 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MIPasteOne Kids Blue RaspberryMI PASTE ONE KIDS BLUE RASPBERRYGC America Inc.bf7d668c-752a-2eee-e053-2a95a90add162025-12-19WarningsExact identifier
application number: M021
MIPaste Plus Tutti FruttiMIPASTE PLUS TUTTI FRUTTIGC America Inc.d724bd2a-2a8e-faeb-e053-2995a90aca192025-12-19WarningsExact identifier
application number: M021
MIPaste Plus VanillaMIPASTE PLUS VANILLAGC America Inc.d7244125-1ca5-78ba-e053-2995a90ab7642025-12-19WarningsExact identifier
application number: M021
MIPaste Plus MelonMIPASTE PLUS MELONGC America Inc.d724fe9f-c9ef-d9ad-e053-2995a90a7ecf2025-12-19WarningsExact identifier
application number: M021
MIPaste Plus MintMIPASTE PLUS MINTGC America Inc.d72415b3-c501-141f-e053-2995a90aaaa32025-12-19WarningsExact identifier
application number: M021
MIPaste One PerioMIPASTE ONE PERIOGC America Inc.d656b72d-48f8-4425-e053-2995a90ab1f22025-12-19WarningsExact identifier
application number: M021
MIPaste One Kids Blue RaspberryMIPASTE ONE KIDS BLUE RASPBERRYGC America Inc.c07e1058-903b-fd47-e053-2995a90afdab2025-12-19WarningsExact identifier
application number: M021
MIPaste Plus StrawberryMIPASTE PLUS STRAWBERRYGC America Inc.d7235ad7-83d7-12e5-e053-2a95a90aaeaf2025-12-19WarningsExact identifier
application number: M021
MIPaste One Kids Cotton CandyMIPASTE ONE KIDS COTTON CANDYGC America Inc.c07d6b50-1d67-ea7f-e053-2a95a90afbe42025-12-19WarningsExact identifier
application number: M021
MIPaste One Kids Bubble GumMIPASTE ONE KIDS BUBBLE GUMGC America Inc.c07c7853-763b-4383-e053-2995a90ab7252025-12-19WarningsExact identifier
application number: M021
MIPaste OneMIPASTE ONEGC America Inc.d71f8e6e-7005-4b3e-e053-2995a90a67892025-12-19WarningsExact identifier
application number: M021
TheraBreath AM-PM Twin PackSODIUM FLUORIDEChurch & Dwight Co., Inc.4618e390-9039-a1d0-e063-6294a90ab2942025-12-16WarningsExact identifier
application number: M021
Parodontax Gum Strengthen and ProtectSTANNOUS FLUORIDEHaleon US Holdings LLC3bb40ceb-841b-4a25-e063-6294a90ab8972025-12-15WarningsExact identifier
application number: M021
Sensodyne Pronamel Kids Bubble MintSODIUM FLUORIDEHaleon US Holdings LLC41b1e626-e79b-d638-e063-6394a90a1f5b2025-12-15WarningsExact identifier
application number: M021
Simple Truth Kids FlourideSODIUM MONOFLUOROPHOSPHATEKroger Company82b9db89-d108-3f64-e053-2991aa0aee742025-12-15WarningsExact identifier
application number: M021
Natural Adult FluorideSODIUM MONOFLUOROPHOSPHATEKrogera71c537e-39d9-1c3b-e053-2a95a90ac3ec2025-12-15WarningsExact identifier
application number: M021
Therabreath Overnight Chamomile MintSODIUM FLUORIDEChurch & Dwight Co., Inc.cc0c533c-145e-4877-b421-1baf3a3a572e2025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.188d28f9-a814-0f98-e063-6294a90a106b2025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELONSODIUM FLUORIDEKingkey MBC Life Technology Group Co.,Ltd1b4cf935-38a6-f4fb-e063-6394a90a4bc02025-12-11Exact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELONSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.188cddb2-c799-0897-e063-6294a90a5d962025-12-11WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN0b269f9a-aa3f-47b5-b7e8-59a5ed0e2b137
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD0b269f9a-aa3f-47b5-b7e8-59a5ed0e2b137
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY0b269f9a-aa3f-47b5-b7e8-59a5ed0e2b137
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY0b269f9a-aa3f-47b5-b7e8-59a5ed0e2b137
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY0b269f9a-aa3f-47b5-b7e8-59a5ed0e2b137
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY0b269f9a-aa3f-47b5-b7e8-59a5ed0e2b137

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79940-004-00799400004001 KIT in 1 KIT (79940-004-00) * 5 g in 1 TUBE (79940-005-05) 1 kit2021-01-190000-00-00NoNoCurrent