NDC 0904-5894

INFANTS GAS RELIEF

Simethicone

INFANTS GAS RELIEF is a Oral Suspension/ Drops in the Human Otc Drug category. It is labeled and distributed by Major Pharmaceuticals Inc.. The primary component is Dimethicone.

Product ID0904-5894_5de14759-c5ac-817a-e053-2a91aa0ad770
NDC0904-5894
Product TypeHuman Otc Drug
Proprietary NameINFANTS GAS RELIEF
Generic NameSimethicone
Dosage FormSuspension/ Drops
Route of AdministrationORAL
Marketing Start Date2010-12-07
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart332
Labeler NameMAJOR Pharmaceuticals Inc.
Substance NameDIMETHICONE
Active Ingredient Strength20 mg/.3mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0904-5894-30

1 BOTTLE, DROPPER in 1 CARTON (0904-5894-30) > 30 mL in 1 BOTTLE, DROPPER
Marketing Start Date2016-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-5894-30 [00904589430]

INFANTS GAS RELIEF SUSPENSION/ DROPS
Marketing CategoryOTC monograph final
Application Numberpart332
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2016-12-01

Drug Details

Active Ingredients

IngredientStrength
DIMETHICONE20 mg/.3mL

OpenFDA Data

SPL SET ID:b58e668f-6415-4ce0-b935-822abfd28932
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198857
  • UPC Code
  • 0309045894309
  • 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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