NDC 35000-728

Colgate Enamel Health Mouthwash

Sodium Fluoride

Colgate Enamel Health Mouthwash is a Dental Rinse in the Human Otc Drug category. It is labeled and distributed by Colgate-palmolive Company. The primary component is Sodium Fluoride.

Product ID35000-728_07c961b1-21e6-4fea-9880-b8093bac7829
NDC35000-728
Product TypeHuman Otc Drug
Proprietary NameColgate Enamel Health Mouthwash
Generic NameSodium Fluoride
Dosage FormRinse
Route of AdministrationDENTAL
Marketing Start Date2015-08-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NameColgate-Palmolive Company
Substance NameSODIUM FLUORIDE
Active Ingredient Strength0 mg/mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 35000-728-16

500 mL in 1 BOTTLE (35000-728-16)
Marketing Start Date2015-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35000-728-33 [35000072833]

Colgate Enamel Health Mouthwash RINSE
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-08-01

NDC 35000-728-84 [35000072884]

Colgate Enamel Health Mouthwash RINSE
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-08-01

NDC 35000-728-16 [35000072816]

Colgate Enamel Health Mouthwash RINSE
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-08-01

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE.1 mg/mL

OpenFDA Data

SPL SET ID:7e264195-b024-440b-bafc-1d200694fdb0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1721964
  • 313029
    • UPC Code
  • 0035000671592

    • NDC Crossover Matching brand name "Colgate Enamel Health Mouthwash" or generic name "Sodium Fluoride"

    NDCBrand NameGeneric Name
    35000-728Colgate Enamel Health MouthwashColgate Enamel Health Mouthwash
    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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