NDC 61508-0200

OroMin

Calcium Chloride, Sodium Fluoride, Sodium Phosphate

OroMin is a Dental Rinse in the Human Otc Drug category. It is labeled and distributed by Germiphene Corporation. The primary component is Sodium Phosphate, Monobasic; Calcium Chloride; Sodium Fluoride.

Product ID61508-0200_51d8d5bd-babb-44c3-e054-00144ff88e88
NDC61508-0200
Product TypeHuman Otc Drug
Proprietary NameOroMin
Generic NameCalcium Chloride, Sodium Fluoride, Sodium Phosphate
Dosage FormRinse
Route of AdministrationDENTAL
Marketing Start Date2017-06-16
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameGermiphene Corporation
Substance NameSODIUM PHOSPHATE, MONOBASIC; CALCIUM CHLORIDE; SODIUM FLUORIDE
Active Ingredient Strength0 g/100g; g/100g; g/100g
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 61508-0200-1

500 g in 1 BOTTLE, PLASTIC (61508-0200-1)
Marketing Start Date2017-06-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61508-0200-2 [61508020002]

OroMin RINSE
Marketing Categoryunapproved drug other
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-06-16
Inactivation Date2020-01-31

NDC 61508-0200-1 [61508020001]

OroMin RINSE
Marketing Categoryunapproved drug other
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-06-16
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
SODIUM PHOSPHATE, MONOBASIC.056 g/100g

OpenFDA Data

SPL SET ID:51d8d5bd-baba-44c3-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1926055
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