NDC 53807-523

Infants Gas Drops

Simethicone

Infants Gas Drops is a Oral Suspension/ Drops in the Human Otc Drug category. It is labeled and distributed by Rij Pharmaceutical Corporation. The primary component is Dimethicone.

Product ID53807-523_39eeac36-8c1d-4a1b-9bf8-5e59c9050f66
NDC53807-523
Product TypeHuman Otc Drug
Proprietary NameInfants Gas Drops
Generic NameSimethicone
Dosage FormSuspension/ Drops
Route of AdministrationORAL
Marketing Start Date1996-03-16
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart332
Labeler NameRij Pharmaceutical Corporation
Substance NameDIMETHICONE
Active Ingredient Strength20 mg/.3mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53807-523-30

30 mL in 1 BOTTLE (53807-523-30)
Marketing Start Date1996-03-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53807-523-30 [53807052330]

Infants Gas Drops SUSPENSION/ DROPS
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart332
Product TypeHUMAN OTC DRUG
Marketing Start Date1996-03-16
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DIMETHICONE20 mg/.3mL

OpenFDA Data

SPL SET ID:469749d4-c83d-48d0-a14b-1e26ff880e33
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198857

    • NDC Crossover Matching brand name "Infants Gas Drops" or generic name "Simethicone"

    NDCBrand NameGeneric Name
    53807-523Infants Gas DropsInfants Gas Drops
    0363-0608Extra Strength Gas ReliefSimethicone
    0363-0125Gas ReliefSimethicone
    0363-0487Gas ReliefSIMETHICONE
    0363-0530Gas ReliefSimethicone
    0363-0635Gas ReliefSimethicone
    0067-0116Gas-XSimethicone
    0067-0117Gas-XSimethicone
    0067-0129Gas-XSimethicone
    0067-0134Gas-XSimethicone
    0067-6274Gas-XSimethicone
    0067-6275Gas-XSimethicone
    0067-6283Gas-XSimethicone
    0113-0428Good Sense Gas ReliefSimethicone
    0113-0657good sense gas reliefSimethicone
    0113-0882good sense simethiconeSimethicone
    0113-6011injoy gas reliefSimethicone
    0132-0208PHAZYMESimethicone
    0132-0211PHAZYMESimethicone
    0132-0214PHAZYMESimethicone
    0132-0215PHAZYMESimethicone
    0132-0217PHAZYME ULTIMATESIMETHICONE
    0363-0118WalgreensSimethicone
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