NDC 50090-2503

INFANTS RELIEF

Simethicone

INFANTS RELIEF is a Oral Suspension/ Drops in the Human Otc Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Dimethicone.

Product ID50090-2503_172623ac-891d-44dd-9064-2a6103f4f819
NDC50090-2503
Product TypeHuman Otc Drug
Proprietary NameINFANTS RELIEF
Generic NameSimethicone
Dosage FormSuspension/ Drops
Route of AdministrationORAL
Marketing Start Date2010-12-07
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameA-S Medication Solutions
Substance NameDIMETHICONE
Active Ingredient Strength20 mg/.3mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50090-2503-0

1 BOTTLE, DROPPER in 1 CARTON (50090-2503-0) > 30 mL in 1 BOTTLE, DROPPER
Marketing Start Date2016-10-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50090-2503-0 [50090250300]

INFANTS RELIEF SUSPENSION/ DROPS
Marketing CategoryOTC monograph final
Application Numberpart332
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-10-13
Marketing End Date2018-06-30

Drug Details

Active Ingredients

IngredientStrength
DIMETHICONE20 mg/.3mL

OpenFDA Data

SPL SET ID:d340d292-f3e3-4d41-8eb0-484c16d0a664
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198857

    • NDC Crossover Matching brand name "INFANTS RELIEF" or generic name "Simethicone"

    NDCBrand NameGeneric Name
    50090-2503INFANTS RELIEFINFANTS RELIEF
    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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