FDA.reportPublic FDA data

NDC 41167-0944-8 - ACT Anticavity Fluoride Kids Bubblegum

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
41167-0944
Requested NDC
41167-0944-8
Package NDCs from labels
41167-0944-1, 41167-0944-3, 41167-0944-8, 41167-0944-2
Manufacturer
Chattem, Inc.
Effective date
2026-01-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ACT Anticavity Fluoride Rinse Kids BubblegumChattem, Inc.2026-01-12HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-0944-1ACT Anticavity Fluoride Kids Bubblegum30 mL in 1 BOTTLE, PLASTICRINSE3012
41167-0944-2ACT Anticavity Fluoride Kids Bubblegum3 in 1 CELLO PACKRINSE312
41167-0944-3ACT Anticavity Fluoride Kids Bubblegum88 mL in 1 BOTTLE, PLASTICRINSE8812
41167-0944-8ACT Anticavity Fluoride Kids Bubblegum500 mL in 1 BOTTLE, DISPENSINGRINSE50012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0944ACT ANTICAVITY FLUORIDE KIDS BUBBLEGUM (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]11Current NDC, Legacy NDC, 4 package rows20240802_fbbccd58-a816-4a93-a658-f28246c11e80.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-0944-8ML - Milliliter41167-0944dc441468-d928-42d3-ac0e-7d037745a27212024-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7ACT ANTICAVITY FLUORIDE KIDS BUBBLEGUM (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]7
FLUORIDE IONACTIVE MOIETYQ80VPU408OACT ANTICAVITY FLUORIDE KIDS BUBBLEGUM (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]7
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHACT ANTICAVITY FLUORIDE KIDS BUBBLEGUM (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]7
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49PACT ANTICAVITY FLUORIDE KIDS BUBBLEGUM (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]7
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LACT ANTICAVITY FLUORIDE KIDS BUBBLEGUM (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]7
EDETATE CALCIUM DISODIUM ANHYDROUSINACTIVE INGREDIENT8U5D034955ACT ANTICAVITY FLUORIDE KIDS BUBBLEGUM (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]7
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ACT ANTICAVITY FLUORIDE KIDS BUBBLEGUM (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]7
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HACT ANTICAVITY FLUORIDE KIDS BUBBLEGUM (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACT ANTICAVITY FLUORIDE KIDS BUBBLEGUM (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]7
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYACT ANTICAVITY FLUORIDE KIDS BUBBLEGUM (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]7
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUACT ANTICAVITY FLUORIDE KIDS BUBBLEGUM (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]7
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37ACT ANTICAVITY FLUORIDE KIDS BUBBLEGUM (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]7
SORBITOLINACTIVE INGREDIENT506T60A25RACT ANTICAVITY FLUORIDE KIDS BUBBLEGUM (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]7
WATERINACTIVE INGREDIENT059QF0KO0RACT ANTICAVITY FLUORIDE KIDS BUBBLEGUM (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]7

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 1 of 89 · 1,776 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLGATE OPTIC WHITE STAIN FIGHTER FRESH MINTSODIUM FLUORIDEColgate-Palmolive Companyb1ef8277-9919-453c-9d21-da4666d952de2026-09-17WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
CrystLCare Regeneration PlusPOTASSIUM NITRATE, SODIUM FLUORIDEGreenMark Biomedical Inc.4f86d0a0-d73e-5605-e063-6394a90adb382026-09-14WarningsExact identifier
unii: 8ZYQ1474W7
TheraBreathSODIUM FLUORIDEChurch & Dwight Co., Inc.53c1086d-264b-9d00-e063-6394a90ad19d2026-09-09WarningsExact identifier
application number: M021
Opalescence Whitening Cool MintSODIUM FLUORIDEUltradent Products, Inc.44e7d0ed-3c37-5889-e063-6294a90afcca2026-09-09WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
Opalescence Whitening Sensitivity ReliefPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.44e94663-895b-67da-e063-6394a90a5fe62026-09-09WarningsExact identifier
unii: 8ZYQ1474W7
Opalescence WhiteningSODIUM FLUORIDEUltradent Products, Incd07f842e-b6f1-4ae1-b576-f542ecd02dd42026-09-09WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
Opalescence Sensitivity Relief WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.b5176a84-76a3-4ad0-a2e2-4997a12da9a52026-09-09WarningsExact identifier
unii: 8ZYQ1474W7
Opal by Opalescence OriginalSODIUM FLUORIDEUltradent Products, Inc.5c3bf8fc-2e8f-4a58-bcbf-e47540072a492026-09-09WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
Opal by Opalescence SensitivityPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.5ffc0d14-0290-47bb-90e5-90a25a5acc282026-09-09WarningsExact identifier
unii: 8ZYQ1474W7
Opal by Opalescence CompleteOPAL BY OPALESCENCE COMPLETEUltradent Products, Inc.249cc46a-dad6-0345-e063-6394a90a44472026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh KnockoutSODIUM FLUORIDEColgate-Palmolive Company0ffbb3a9-7bfa-4f6a-aef3-fde327a410c92026-09-09WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
Colgate MaxFresh CharcoalSODIUM FLUORIDEColgate-Palmolive Companyde3674f4-3ce6-47d5-8391-6ad6789d68d92026-09-09WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
Colgate Optic White Stain Fighter Sens ReliefSODIUM FLUORIDEColgate-Palmolive Company6ec2fff7-df44-4302-be2d-97946c6cd66a2026-09-08WarningsExact identifier
unii: 8ZYQ1474W7
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Incef108fff-a79c-4e8d-8bf0-3fe567f93eb82026-09-08WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Inc1a42cf2d-6c48-4e38-97bc-b6f2084bf39b2026-09-08WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
Freshmint Premium Anticavity GelSODIUM FLUORIDENew World Imports, Incdfe564c1-2097-431d-93f0-cf423f2542482026-09-08WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
Freshmint Anticavity FluorideSODIUM MONOFLUOROPHOSPHATENew World Imports, Inc5aff7e41-58cd-5ab8-e063-6294a90aa1c72026-09-08WarningsExact identifier
application number: M021
Colgate Optic White Advanced Sparkling WhiteSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companybc56603d-4190-48c1-b16e-3179a650cb392026-09-06WarningsExact identifier
application number: M021
Dentalclean Advanced ProSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda4d261dc8-b065-567f-e063-6294a90aa93f2026-09-04WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude54bd43c9-489d-4e6b-9031-90ec0e3c45162026-09-01WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.