Colgate Kids Unicorn Alcohol Free

Product NDC
35000-334
11-digit product format
350000334
Labeler code
35000
Product ID
35000-334_0471d13b-4002-44bb-bfdd-7fec76212280
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
RINSE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-01-05
Substance
SODIUM FLUORIDE
Active strength
.1 mg/mL
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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct35000-334DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage35000-33435000-334-84DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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 Kids Unicorn Alcohol Free
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.1 mg/mL

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
313029Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
133acaff-7205-80d7-e91d-3eb37087cae4Available 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
35000-334-84Colgate Kids Unicorn Alcohol Free500 mL in 1 BOTTLERINSE5005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-334COLGATE KIDS UNICORN ALCOHOL FREE (SODIUM FLUORIDE) RINSE [COLGATE-PALMOLIVE COMPANY]2Current NDC, Legacy NDC, 1 package rows20240110_133acaff-7205-80d7-e91d-3eb37087cae4.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 23 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest complete plus Whitening Deep CleanSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company973ce138-c64e-c059-e053-2a95a90a31482026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Gum Detoxify and Restore Pro Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4c3ad36-72d8-16e8-e053-2a95a90a87022026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Gum Detoxify and Restore Pro WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4d65b58-9818-820d-e053-2995a90a9f002026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Sensitive and Gum All Day ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4d775a1-a4f6-cd69-e053-2995a90a5f642026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Enamel Repair and Gum Advanced WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4ead762-17b2-22a0-e053-2a95a90ac8662026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Luminous MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf5c82742-fb27-62a2-e053-2a95a90aa7c42026-01-08WarningsExact identifier
application number: M021
Native WhiteningSODIUM FLUORIDEProcter & Gamble Manufacturing Companya5248d35-f488-3457-e053-2995a90a411e2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance CharcoalSODIUM FLUORIDEProcter & Gamble Manfuacturing Companyb7882679-339c-554f-e053-2995a90afa7f2026-01-08WarningsExact identifier
application number: M021
Burts Bees Kids Strawberry SplashSODIUM FLUORIDEProcter & Gamble Manufacturing Companyb6c180ae-00da-6fab-e053-2a95a90a089e2026-01-08WarningsExact identifier
application number: M021
Crest Complete Plus Scope OutlastSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb6f9a813-7ed6-895c-e053-2995a90a9ea62026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Scope Dual Blast Active FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb788d16a-8a58-0352-e053-2a95a90a965e2026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Scope Outlast Active FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb789587e-7f49-163a-e053-2a95a90a823f2026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Advanced Whitening Active FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb81a22dc-b759-24cd-e053-2995a90a91482026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Deep Clean Active FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb851fe5c-d904-12da-e053-2a95a90a86f92026-01-08WarningsExact identifier
application number: M021
Crest Baking Soda and Peroxide Whitening with Tartar ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyadebbd47-011d-4cd3-a002-1eb67e885e5b2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Stain ShieldSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf5c9b5ef-8dd4-a842-e053-2a95a90ad3872026-01-08WarningsExact identifier
application number: M021
Kids Crest Bubblegum RushSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company7baa77f5-fe45-6566-e053-2991aa0a381f2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Vibrant MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf63c3354-a264-8130-e053-2a95a90a20222026-01-08Exact identifier
application number: M021
Crest Pro Health Clean MintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb466fb4-0915-a41f-e053-6294a90a2dfb2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Clean and FreeSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb4771cd-f478-e2bd-e053-6394a90aa83e2026-01-08WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN133acaff-7205-80d7-e91d-3eb37087cae45
313029sodium fluoride 0.2 MG/ML MouthwashSCD133acaff-7205-80d7-e91d-3eb37087cae45
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY133acaff-7205-80d7-e91d-3eb37087cae45
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY133acaff-7205-80d7-e91d-3eb37087cae45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-334-8435000033484500 mL in 1 BOTTLE (35000-334-84) 500 ml2022-01-050000-00-00NoNoCurrent