NDC 49580-0325

Infants Gas Relief

Simethicone

Infants Gas Relief is a Oral Suspension in the Human Otc Drug category. It is labeled and distributed by P & L Development, Llc. The primary component is Dimethicone.

Product ID49580-0325_04b28425-d504-40f9-b96a-eda1ac3856e1
NDC49580-0325
Product TypeHuman Otc Drug
Proprietary NameInfants Gas Relief
Generic NameSimethicone
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2015-06-30
Marketing End Date2020-12-31
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart332
Labeler NameP & L Development, LLC
Substance NameDIMETHICONE
Active Ingredient Strength20 mg/.3mL
NDC Exclude FlagN

Packaging

NDC 49580-0325-1

1 BOTTLE in 1 BOX (49580-0325-1) > 30 mL in 1 BOTTLE
Marketing Start Date2015-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49580-0325-1 [49580032501]

Infants Gas Relief SUSPENSION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart332
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-06-30
Marketing End Date2020-12-31

Drug Details

Active Ingredients

IngredientStrength
DIMETHICONE20 mg/.3mL

OpenFDA Data

SPL SET ID:a7708e44-a1e2-4b2c-b2f8-0fcdac492b37
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198857
  • NDC Crossover Matching brand name "Infants Gas Relief" or generic name "Simethicone"

    NDCBrand NameGeneric Name
    69842-231infants gas reliefinfants gas relief
    70000-0423INFANTS GAS RELIEFINFANTS GAS RELIEF
    0904-5894INFANTS GAS RELIEFINFANTS GAS RELIEF
    17856-5894Infants Gas ReliefInfants Gas Relief
    37012-882Infants Gas ReliefInfants Gas Relief
    49580-0325Infants Gas ReliefInfants Gas Relief
    55319-325Infants Gas ReliefInfants Gas Relief
    57896-798INFANTS GAS RELIEFINFANTS GAS 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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