FDA.reportPublic FDA data

ACT Kids Anticavity Fluoride

Product NDC
41167-0922
11-digit product format
411670922
Labeler code
41167
Product ID
41167-0922_ea287112-f84f-4710-a126-c821481d5793
Type
HUMAN OTC DRUG
Nonproprietary name
sodium fluoride
Dosage form
PASTE
Route
TOPICAL
Labeler
Chattem, Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-11-01
Substance
SODIUM FLUORIDE
Active strength
1.4 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ACT Kids Anticavity Fluoride
Brand name suffix
Bubble Gum Blowout
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.4 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-0922-2ACT Kids Anticavity FluorideBubble Gum Blowout130 g in 1 TUBEPASTE1308
41167-0922-4ACT Kids Anticavity FluorideBubble Gum Blowout11 g in 1 TUBEPASTE118

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0922ACT KIDS ANTICAVITY FLUORIDE BUBBLE GUM BLOWOUT (SODIUM FLUORIDE) PASTE [CHATTEM, INC.]8Current NDC, Legacy NDC, 2 package rows20250130_61f3a3e6-645b-4368-b1d5-7de1fc14542e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-0922-241167092202130 g in 1 TUBE (41167-0922-2) 130 g2016-11-010000-00-00NoNoCurrent
41167-0922-44116709220411 g in 1 TUBE (41167-0922-4) 11 g2016-11-010000-00-00NoNoCurrent