NDC 77055-100

Biomin Restore Plus

Sodium Fluoride

Biomin Restore Plus is a Dental Paste, Dentifrice in the Human Otc Drug category. It is labeled and distributed by Drcollins, Inc.. The primary component is Sodium Fluoride.

Product ID77055-100_a47a410f-3a69-2024-e053-2995a90acdaf
NDC77055-100
Product TypeHuman Otc Drug
Proprietary NameBiomin Restore Plus
Generic NameSodium Fluoride
Dosage FormPaste, Dentifrice
Route of AdministrationDENTAL
Marketing Start Date2020-05-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NameDRCOLLINS, INC.
Substance NameSODIUM FLUORIDE
Active Ingredient Strength1 mg/g
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 77055-100-01

1 TUBE in 1 CARTON (77055-100-01) > 100 g in 1 TUBE
Marketing Start Date2020-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 77055-100-01 [77055010001]

Biomin Restore Plus PASTE, DENTIFRICE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-05-01

Drug Details

NDC Crossover Matching brand name "Biomin Restore Plus" or generic name "Sodium Fluoride"

NDCBrand NameGeneric Name
77055-100Biomin Restore PlusBiomin Restore Plus
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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