NDC 53345-032

Simethicone

Simethicone

Simethicone is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Humanwell Puracap Pharmaceutical (wuhan) Co., Ltd. The primary component is Dimethicone.

Product ID53345-032_48569d4d-19fe-4dc6-b2f6-b77429cf848e
NDC53345-032
Product TypeHuman Otc Drug
Proprietary NameSimethicone
Generic NameSimethicone
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2016-06-30
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart332
Labeler NameHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd
Substance NameDIMETHICONE
Active Ingredient Strength250 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53345-032-02

124 BLISTER PACK in 1 BOX (53345-032-02) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date2016-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53345-032-02 [53345003202]

Simethicone CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart332
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-06-30

NDC 53345-032-01 [53345003201]

Simethicone CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart332
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-01-28

Drug Details

Active Ingredients

IngredientStrength
DIMETHICONE250 mg/1

OpenFDA Data

SPL SET ID:0c9c5fec-ddd4-41a5-8ff9-6b55c376dd36
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 412111

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

    NDCBrand NameGeneric Name
    68071-4207SimethiconeSimethicone
    68210-1902SIMETHICONESIMETHICONE
    68210-1901SIMETHICONESIMETHICONE
    68788-9285SimethiconeSimethicone
    0536-3604SimethiconeSimethicone
    11788-032SimethiconeSimethicone
    11788-031SimethiconeSimethicone
    17714-040SimethiconeSimethicone
    48769-112SIMETHICONESIMETHICONE
    48769-113SimethiconeSimethicone
    51013-439SimethiconeSimethicone
    53345-033SimethiconeSimethicone
    53345-032SimethiconeSimethicone
    53345-009SimethiconeSimethicone
    53345-036SimethiconeSimethicone
    55154-1480SimethiconeSimethicone
    54738-518SimethiconeSimethicone
    57896-791SIMETHICONESIMETHICONE
    67544-767SimethiconeSimethicone
    0363-9945SimethiconeSimethicone
    68210-0314SimethiconeSimethicone
    68210-3130SimethiconeSimethicone
    68210-4091SimethiconeSimethicone
    37808-788SimethiconeSimethicone
    55629-010SimethiconeSimethicone
    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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