NDC 69890-010

AMHEALER

Sodium Fluoride

AMHEALER is a Oral Spray in the Human Otc Drug category. It is labeled and distributed by Healingam Co., Ltd. The primary component is Sodium Fluoride.

Product ID69890-010_fdc7b831-f053-41f5-b013-3b5bee4444e6
NDC69890-010
Product TypeHuman Otc Drug
Proprietary NameAMHEALER
Generic NameSodium Fluoride
Dosage FormSpray
Route of AdministrationORAL
Marketing Start Date2015-05-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NameHEALINGAM CO., LTD
Substance NameSODIUM FLUORIDE
Active Ingredient Strength0 mg/35mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 69890-010-01

35 mL in 1 CARTON (69890-010-01)
Marketing Start Date2015-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69890-010-01 [69890001001]

AMHEALER SPRAY
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-05-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE.007 mg/35mL

OpenFDA Data

SPL SET ID:81817163-a5b5-4eaa-b014-085c6098d022
Manufacturer
UNII

NDC Crossover Matching brand name "AMHEALER" or generic name "Sodium Fluoride"

NDCBrand NameGeneric Name
69890-010AMHEALERAMHEALER
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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