NDC 41167-0978

ACT Restoring Anticavity Fluoride Mint Burst

Sodium Fluoride

ACT Restoring Anticavity Fluoride Mint Burst is a Oral Mouthwash in the Human Otc Drug category. It is labeled and distributed by Chattem, Inc.. The primary component is Sodium Fluoride.

Product ID41167-0978_75e52a6f-9581-4e6f-b8a8-6ff095e103d6
NDC41167-0978
Product TypeHuman Otc Drug
Proprietary NameACT Restoring Anticavity Fluoride Mint Burst
Generic NameSodium Fluoride
Dosage FormMouthwash
Route of AdministrationORAL
Marketing Start Date2015-12-16
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NameChattem, Inc.
Substance NameSODIUM FLUORIDE
Active Ingredient Strength0 mg/mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 41167-0978-1

30 mL in 1 BOTTLE, PLASTIC (41167-0978-1)
Marketing Start Date2016-02-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 41167-0978-3 [41167097803]

ACT Restoring Anticavity Fluoride Mint Burst MOUTHWASH
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-12-16

NDC 41167-0978-6 [41167097806]

ACT Restoring Anticavity Fluoride Mint Burst MOUTHWASH
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-12-16
Marketing End Date2018-07-07

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE.2 mg/mL

OpenFDA Data

SPL SET ID:0c7ede82-3b28-40ae-8dfd-cec58825f938
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313029
  • 1044540
  • NDC Crossover Matching brand name "ACT Restoring Anticavity Fluoride Mint Burst" or generic name "Sodium Fluoride"

    NDCBrand NameGeneric Name
    41167-0978ACT Restoring Anticavity Fluoride Mint BurstACT Restoring Anticavity Fluoride Mint Burst
    41167-0979ACT Restoring Anticavity Fluoride Mint BurstACT Restoring Anticavity Fluoride Mint Burst
    0135-0234AQUAFRESHsodium fluoride
    0126-0021ColgateSODIUM FLUORIDE
    0126-0034Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape FluorideSODIUM FLUORIDE
    0126-0032Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint FluorideSODIUM FLUORIDE
    0041-1421Oral-BSodium Fluoride
    0126-0131Phos-FlurSodium Fluoride
    0126-0135Phos-Flur Ortho DefenseSODIUM FLUORIDE
    0126-0138Phos-Flur Ortho DefenseSODIUM FLUORIDE
    0126-0139Phos-Flur Ortho DefenseSODIUM FLUORIDE
    0126-0074PrevidDent 5000 Booster Plus SpearmintSodium Fluoride
    0126-0016PreviDentSodium fluoride
    0126-0075PreviDentSodium fluoride
    0126-0076PreviDentSodium fluoride
    0126-0179PreviDentSodium Fluoride
    0126-0286PreviDentSodium Fluoride
    0126-0287PreviDentSodium Fluoride
    0126-0072PreviDent 5000 Booster Plus FruitasticSodium Fluoride
    0126-0033PreviDent Alcohol FreeSodium Fluoride
    0126-0088PreviDent Fresh MintSodium Fluoride
    0126-0289PreviDent OrthoDefenseSODIUM FLUORIDE
    0126-0288PreviDent Very BerrySodium Fluoride

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