NDC 52376-045

SUNSTAR G.U.M HYDRAL DRY MOUTH RELIEF

Sodium Fluoride

SUNSTAR G.U.M HYDRAL DRY MOUTH RELIEF is a Dental Paste, Dentifrice in the Human Otc Drug category. It is labeled and distributed by Sunstar Americas, Inc.. The primary component is Sodium Fluoride.

Product ID52376-045_ee54606f-0ac7-4064-a941-7db65df1eaaa
NDC52376-045
Product TypeHuman Otc Drug
Proprietary NameSUNSTAR G.U.M HYDRAL DRY MOUTH RELIEF
Generic NameSodium Fluoride
Dosage FormPaste, Dentifrice
Route of AdministrationDENTAL
Marketing Start Date2019-11-19
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NameSunstar Americas, Inc.
Substance NameSODIUM FLUORIDE
Active Ingredient Strength0 g/100g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52376-045-11

1 TUBE in 1 CARTON (52376-045-11) > 119 g in 1 TUBE
Marketing Start Date2019-11-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52376-045-11 [52376004511]

SUNSTAR G.U.M HYDRAL DRY MOUTH RELIEF PASTE, DENTIFRICE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-11-19

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE.24 g/100g

NDC Crossover Matching brand name "SUNSTAR G.U.M HYDRAL DRY MOUTH RELIEF" or generic name "Sodium Fluoride"

NDCBrand NameGeneric Name
52376-045SUNSTAR G.U.M HYDRAL DRY MOUTH RELIEFSUNSTAR G.U.M HYDRAL DRY MOUTH RELIEF
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.