NDC 46122-547

INFANT GAS RELIEF

Simethicone

INFANT GAS RELIEF is a Oral Suspension/ Drops in the Human Otc Drug category. It is labeled and distributed by Amerisourcebergen Drug Corporation. The primary component is Dimethicone.

Product ID46122-547_7d3c33bb-46be-82ba-e053-2991aa0a9d75
NDC46122-547
Product TypeHuman Otc Drug
Proprietary NameINFANT GAS RELIEF
Generic NameSimethicone
Dosage FormSuspension/ Drops
Route of AdministrationORAL
Marketing Start Date2018-06-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart332
Labeler NameAMERISOURCEBERGEN DRUG CORPORATION
Substance NameDIMETHICONE
Active Ingredient Strength20 mg/.3mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 46122-547-03

1 BOTTLE, DROPPER in 1 CARTON (46122-547-03) > 30 mL in 1 BOTTLE, DROPPER
Marketing Start Date2018-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 46122-547-03 [46122054703]

INFANT GAS RELIEF SUSPENSION/ DROPS
Marketing CategoryOTC monograph final
Application Numberpart332
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2018-06-01

Drug Details

Active Ingredients

IngredientStrength
DIMETHICONE20 mg/.3mL

OpenFDA Data

SPL SET ID:7d3c3cc6-b0a2-620d-e053-2a91aa0a159b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198857
  • NDC Crossover Matching brand name "INFANT GAS RELIEF" or generic name "Simethicone"

    NDCBrand NameGeneric Name
    46122-547INFANT GAS RELIEFINFANT 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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