NDC 48769-113

Simethicone

Dimethicone

Simethicone is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Softech Pharma Pvt. Ltd. The primary component is Dimethicone.

Product ID48769-113_7871e699-2df2-4655-b2db-a2b721d145ac
NDC48769-113
Product TypeHuman Otc Drug
Proprietary NameSimethicone
Generic NameDimethicone
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2012-01-15
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart332
Labeler NameSoftech Pharma Pvt. Ltd
Substance NameDIMETHICONE
Active Ingredient Strength125 mg/1
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 48769-113-99

5000 CAPSULE, LIQUID FILLED in 1 BAG (48769-113-99)
Marketing Start Date2012-01-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 48769-113-99 [48769011399]

Simethicone CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart332
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-01-15
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DIMETHICONE125 mg/1

OpenFDA Data

SPL SET ID:f7ab5814-f48c-4f35-99e1-3db96316351f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198852
  • NDC Crossover Matching brand name "Simethicone" or generic name "Dimethicone"

    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
    0132-0326Boudreauxs Butt BarrierDimethicone
    0187-2218CeraVeDimethicone
    0187-2219CeraVedimethicone
    0187-2489CeraVedimethicone
    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
    0259-2202Mederma PMDimethicone
    0259-2102Mederma Stretch Marks Therapydimethicone
    0093-3204MoisturelDimethicone
    0132-0208PHAZYMESimethicone
    0132-0211PHAZYMESimethicone
    0132-0214PHAZYMESimethicone
    0132-0215PHAZYMESimethicone
    0132-0217PHAZYME ULTIMATESIMETHICONE
    0132-8744Summers Eve Active ChafeDimethicone
    0187-1660TheraSealDimethicone

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