FDA.reportPublic FDA data

ACT Anticavity Fluoride Kids Bubblegum

Product NDC
41167-0944
11-digit product format
411670944
Labeler code
41167
Product ID
41167-0944_c6595574-2b59-42cb-993e-78b8d5729948
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium fluoride
Dosage form
RINSE
Route
TOPICAL
Labeler
Chattem, Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1993-02-01
Substance
SODIUM FLUORIDE
Active strength
.2 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
ACT Anticavity Fluoride Kids Bubblegum
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.2 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
240698Internal RxNorm lookup
656809Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fbbccd58-a816-4a93-a658-f28246c11e80Available on FDA.report

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 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

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

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 9 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Restore and DefendSTANNOUS FLUORIDEWalgreense808ea4b-9081-085b-e053-2a95a90a4f9b2026-06-02WarningsExact identifier
application number: M021
Hello Unicorn Splash unicorn splash anticavity fluoride rinseSODIUM FLUORIDEColgate-Palmolive Companya1014431-7d23-aaff-6dc7-ab58683d03382026-06-02WarningsExact identifier
application number: M021
Therabreath AnticavitySODIUM FLUORIDEChurch & Dwight Co., Inc.feab3d45-ff95-4b32-8258-7d932a7380c92026-06-01WarningsExact identifier
application number: M021
Orajel Toy Story 5 AnticavitySODIUM FLUORIDEChurch & Dwight Co., Inc.4b80947d-f389-2f80-e063-6294a90abd552026-06-01WarningsExact identifier
application number: M021
Arm and HammerSODIUM FLUORIDEChurch & Dwight Co., Inc.54113245-0c1e-739e-e063-6294a90aea422026-06-01WarningsExact identifier
application number: M021
Arm and HammerSODIUM FLUORIDEChurch & Dwight Co., Inc.545258fd-8179-fffc-e063-6394a90a467f2026-06-01WarningsExact identifier
application number: M021
Orajel Paw PatrolSODIUM FLUORIDEChurch & Dwight Co., Inc.99d87bea-3e99-5d04-e053-2a95a90aaf542026-06-01WarningsExact identifier
application number: M021
Orajel SuperMarioANTICAVITY TOOTHPASTEChurch & Dwight Co., Inc.27d2f6cb-8661-da9c-e063-6394a90a5bde2026-06-01WarningsExact identifier
application number: M021
Orajel KidsToothpasteSODIUM FLUORIDEChurch & Dwight Co., Inc.99d62125-c2c5-5926-e053-2995a90aaa292026-06-01WarningsExact identifier
application number: M021
AIM CAVITY PROTECTION Multi BenefitSODIUM FLUORIDEChurch & Dwight Co., Inc.1d0f8a33-0b01-40e2-e054-00144ff88e882026-06-01WarningsExact identifier
application number: M021
Crest plus Tartar Protection WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company560980ea-749f-593d-e063-6394a90a1b9e2026-06-01WarningsExact identifier
application number: M021
Colgate Revitalizing WhiteSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyc67223ae-b068-41c5-a15b-7ae9840b93ef2026-05-27WarningsExact identifier
application number: M021
Colgate Kids Harry PotterSODIUM FLUORIDEColgate-Palmolive Company61c06da4-9f02-4fbc-b80f-1c443e2984962026-05-26WarningsExact identifier
application number: M021
sodium fluoride rinseSODIUM FLUORIDE RINSERockland Cosmetics, Inc.52430b12-4d5f-d1e1-e063-6394a90abd642026-05-20Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEH E Bd0a52519-3339-40ea-93e5-78f76d348a4d2026-05-14Warnings, Adverse reactionsExact identifier
application number: M021
Burts Bees Extra WhiteSODIUM FLUORIDEProcter & Gamble Manufacturing Companyc92524fd-8b93-592d-e053-2a95a90a88c62026-05-13WarningsExact identifier
application number: M021
MIPaste Plus StrawberrySODIUM FLUORIDEGC America Inc.1b68bd67-65d3-4c64-e054-00144ff8d46c2026-05-12WarningsExact identifier
application number: M021
White Glo Purple Color Corrector Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inc6f8b77c3-9833-4c75-b41c-a2bc126161572026-05-12WarningsExact identifier
application number: M021
botalab HERBAL COMPLETE TOOTHSODIUM FLUORIDEKMPHARMACEUTICAL CO., LTD.51365ef7-ed94-2650-e063-6394a90ab89e2026-05-07WarningsExact identifier
application number: M021
Morning Fresh Mint Toothpaste, with FluorideMORNING FRESH MINT TOOTHPASTE, WITH FLUORIDEDynarex Corporation2a42d8ce-e7f2-caa5-e063-6294a90ac01f2026-05-07WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
656809ACT 0.05 % (fluoride ion 0.02 % ) MouthwashPSNfbbccd58-a816-4a93-a658-f28246c11e8012
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSNfbbccd58-a816-4a93-a658-f28246c11e8012
656809sodium fluoride 0.5 MG/ML Mouthwash [ACT Fluoride Rinse]SBDfbbccd58-a816-4a93-a658-f28246c11e8012
240698sodium fluoride 0.5 MG/ML MouthwashSCDfbbccd58-a816-4a93-a658-f28246c11e8012
656809ACT Fluoride Rinse 0.05 % (as fluoride ion 0.02 % ) MouthwashSYfbbccd58-a816-4a93-a658-f28246c11e8012
656809ACT Fluoride Rinse 0.5 MG/ML MouthwashSYfbbccd58-a816-4a93-a658-f28246c11e8012
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSYfbbccd58-a816-4a93-a658-f28246c11e8012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-0944-14116709440130 mL in 1 BOTTLE, PLASTIC (41167-0944-1) 30 ml1993-02-010000-00-00NoNoCurrent
41167-0944-2411670944023 BOTTLE, DISPENSING in 1 CELLO PACK (41167-0944-2) / 500 mL in 1 BOTTLE, DISPENSING (41167-0944-8) 1993-02-010000-00-00NoNoCurrent
41167-0944-34116709440388 mL in 1 BOTTLE, PLASTIC (41167-0944-3) 88 ml1993-02-010000-00-00NoNoCurrent
41167-0944-841167094408500 mL in 1 BOTTLE, DISPENSING500 mlHistorical