FDA.reportPublic FDA data

Colgate Minions Mild Bubble Fruit Fluoride

Product NDC
35000-971
11-digit product format
350000971
Labeler code
35000
Product ID
35000-971_ff71a638-7218-48b4-9efe-4503c0683f1b
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-03-12
Marketing end
2026-12-01
Substance
SODIUM FLUORIDE
Active strength
1.1 mg/g
NDC exclude flag
No
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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage35000-971-46ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage35000-971-46367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage35000-971-46557ba5c1ecfa…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
Colgate Minions Mild Bubble Fruit Fluoride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.1 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
416783Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
16634b99-f305-48bf-ac54-a9f53797a9e5Available 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
35000-971-46Colgate Minions Mild Bubble Fruit Fluoride130 g in 1 TUBEPASTE, DENTIFRICE1304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-971COLGATE MINIONS MILD BUBBLE FRUIT FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]3Current NDC, Legacy NDC, 1 package rows20241215_16634b99-f305-48bf-ac54-a9f53797a9e5.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 14 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AnticavitySODIUM FLUORIDEOld East Main Co.64f3d92d-f58c-4bc2-8819-f91492221ddb2026-03-02Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEOld East Main Co.c7b9e9cd-3cf7-4657-83c9-e221e1c359772026-03-02Warnings, Adverse reactionsExact identifier
application number: M021
Instant WhiteningINSTANT WHITENING TOOTHPASTEGuangzhou City Caiye Cosmetics CO., Ltd2807ece8-a1a5-b626-e063-6394a90aac622026-03-02WarningsExact identifier
application number: M021
Coffe Tea Stain Remover ToothCOFFE TEA STAIN REMOVER TOOTHPASTEGuangzhou City Caiye Cosmetics CO., Ltd2845d7af-7a0b-9bc8-e063-6294a90ac8b32026-03-02WarningsExact identifier
application number: M021
Professional whitening toothPROFESSIONAL WHITENING TOOTHPASTEGuangzhou City Caiye Cosmetics CO., Ltd291eba71-14da-fac3-e063-6294a90aa3cc2026-03-02WarningsExact identifier
application number: M021
purple toothPURPLE TOOTHPASTEGuangzhou City Caiye Cosmetics CO., Ltd291f0312-238c-71d5-e063-6294a90a39e12026-03-02WarningsExact identifier
application number: M021
Professional ChoicePROFESSIONAL CHOICE TOOTHPASTEGuangzhou City Caiye Cosmetics CO., Ltd28406739-6a8c-1ce8-e063-6394a90a08f82026-03-02WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEThe Kroger Co.27a98b64-8369-4f3d-b487-d7ce98abc69f2026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEThe Kroger Co.390dd1b5-2dd1-4b55-b4b3-e441ada612382026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEThe Kroger Co.5459eeee-adf0-4afe-b190-62d4fa1138062026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDEThe Kroger Co.932723b8-9875-4f37-8c11-018c94ae0ae12026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEThe Kroger Co.d0c552d8-44ad-4d95-b3fb-17015f44b3342026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDEWalmart Inc.3beb65e4-ae8e-4e51-b9ba-181cbec41eff2026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEWalmart Inc.61669087-0af6-4192-b514-afcfe7d8ba982026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEWalmart Inc.e79e43e6-d6b6-4df4-9d9f-fe9fe35f180d2026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEWalmart Inc.1fd2f3ca-066e-282a-e063-6294a90a05a92026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEWalmart Inc.af5b93e7-5cce-4e01-8df2-54494d8b29102026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEWalmart Inc.4590ca97-130c-46b2-9ba0-38f4703ef30a2026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEMING FAI ENTERPRISE (CAMBODIA) CO., LTD.4ba81636-cdb7-e904-e063-6394a90a8bd52026-02-25WarningsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDEFamily Dollar Stores, Inc32a92add-c9db-4733-8e35-613825fdf0812026-02-24Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN16634b99-f305-48bf-ac54-a9f53797a9e54
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD16634b99-f305-48bf-ac54-a9f53797a9e54
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY16634b99-f305-48bf-ac54-a9f53797a9e54
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY16634b99-f305-48bf-ac54-a9f53797a9e54
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY16634b99-f305-48bf-ac54-a9f53797a9e54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-971-4635000097146130 g in 1 TUBE (35000-971-46) 130 g2015-03-122026-12-01NoNoCurrent