NDC 58988-0027

Sanafitil Extra Strength

Simethicone

Sanafitil Extra Strength is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Promex Llc. The primary component is Dimethicone.

Product ID58988-0027_0c14873c-f8a5-087a-e054-00144ff88e88
NDC58988-0027
Product TypeHuman Otc Drug
Proprietary NameSanafitil Extra Strength
Generic NameSimethicone
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2014-01-08
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart332
Labeler NamePromex LLC
Substance NameDIMETHICONE
Active Ingredient Strength125 mg/1
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 58988-0027-1

10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58988-0027-1)
Marketing Start Date2014-01-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58988-0027-1 [58988002701]

Sanafitil Extra Strength CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart332
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-01-08
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DIMETHICONE125 mg/1

OpenFDA Data

SPL SET ID:0c1467f3-dab6-353b-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198852
    • UPC Code
  • 0184125000272

    • NDC Crossover Matching brand name "Sanafitil Extra Strength" or generic name "Simethicone"

    NDCBrand NameGeneric Name
    58988-0027Sanafitil Extra StrengthSanafitil Extra Strength
    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

    Trademark Results [Sanafitil]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SANAFITIL
    SANAFITIL
    72253064 0829697 Live/Registered
    TARMAC PRODUCTS, INC.
    1966-08-24
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