NDC 41525-5001

The Gargle

Sodium Fluoride

The Gargle is a Dental Mouthwash in the Human Otc Drug category. It is labeled and distributed by Pbs Co., Ltd.. The primary component is Sodium Fluoride.

Product ID41525-5001_a70078b9-c78a-4fd5-8b1e-0e8ac22eb2eb
NDC41525-5001
Product TypeHuman Otc Drug
Proprietary NameThe Gargle
Generic NameSodium Fluoride
Dosage FormMouthwash
Route of AdministrationDENTAL
Marketing Start Date2014-09-11
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NamePBS Co., Ltd.
Substance NameSODIUM FLUORIDE
Active Ingredient Strength0 mg/100mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 41525-5001-2

10 POUCH in 1 PACKAGE (41525-5001-2) > 11 mL in 1 POUCH (41525-5001-1)
Marketing Start Date2014-09-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 41525-5001-2 [41525500102]

The Gargle MOUTHWASH
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-09-11
Inactivation Date2019-11-27

NDC 41525-5001-3 [41525500103]

The Gargle MOUTHWASH
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-09-11
Inactivation Date2019-11-27

NDC 41525-5001-1 [41525500101]

The Gargle MOUTHWASH
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-09-11

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE.02 mg/100mL

OpenFDA Data

SPL SET ID:f8a166bf-cdb2-4fe8-9d74-1bb95a3fc28f
Manufacturer
UNII

NDC Crossover Matching brand name "The Gargle" or generic name "Sodium Fluoride"

NDCBrand NameGeneric Name
41525-7001The GargleThe Gargle
41525-5001The GargleThe Gargle
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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