NDC 68210-1901

SIMETHICONE

Dimethicone

SIMETHICONE is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Spirit Pharmaceuticals,llc. The primary component is Dimethicone.

Product ID68210-1901_76774f7e-63c1-4ce3-8e70-07bb9408b59a
NDC68210-1901
Product TypeHuman Otc Drug
Proprietary NameSIMETHICONE
Generic NameDimethicone
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2010-03-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart332
Labeler NameSPIRIT PHARMACEUTICALS,LLC
Substance NameDIMETHICONE
Active Ingredient Strength125 mg/1
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 68210-1901-1

10 CAPSULE, LIQUID FILLED in 1 BOX (68210-1901-1)
Marketing Start Date2010-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68210-1901-4 [68210190104]

SIMETHICONE CAPSULE, LIQUID FILLED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart332
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-03-01
Inactivation Date2020-01-31

NDC 68210-1901-2 [68210190102]

SIMETHICONE CAPSULE, LIQUID FILLED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart332
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-03-01
Inactivation Date2020-01-31

NDC 68210-1901-5 [68210190105]

SIMETHICONE CAPSULE, LIQUID FILLED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart332
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-03-01
Inactivation Date2020-01-31

NDC 68210-1901-3 [68210190103]

SIMETHICONE CAPSULE, LIQUID FILLED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart332
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-03-01
Inactivation Date2020-01-31

NDC 68210-1901-1 [68210190101]

SIMETHICONE CAPSULE, LIQUID FILLED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart332
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-03-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DIMETHICONE125 mg/1

OpenFDA Data

SPL SET ID:79eb60b1-f651-4f9c-8d20-a8eacfcfbbe8
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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.