NDC 67544-767

Simethicone

Simethicone

Simethicone is a Oral Tablet, Chewable in the Human Otc Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Dimethicone.

Product ID67544-767_7fa2db15-e9e9-4e97-b544-208e64f73ba3
NDC67544-767
Product TypeHuman Otc Drug
Proprietary NameSimethicone
Generic NameSimethicone
Dosage FormTablet, Chewable
Route of AdministrationORAL
Marketing Start Date1999-03-12
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart332
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameDIMETHICONE
Active Ingredient Strength80 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 67544-767-04

4 TABLET, CHEWABLE in 1 BOTTLE (67544-767-04)
Marketing Start Date2013-02-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67544-767-04 [67544076704]

Simethicone TABLET, CHEWABLE
Marketing CategoryOTC monograph final
Application Numberpart332
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2013-02-06

Drug Details

Active Ingredients

IngredientStrength
DIMETHICONE80 mg/1

OpenFDA Data

SPL SET ID:9e9f4c61-df0b-43c2-8887-2371cdd12ebc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314216
  • 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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