NDC 70518-1813

Simethicone 125 mg

Simethicone

Simethicone 125 mg is a Oral Tablet, Chewable in the Human Otc Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Dimethicone.

Product ID70518-1813_84148213-3e22-4e78-e053-2a91aa0a589a
NDC70518-1813
Product TypeHuman Otc Drug
Proprietary NameSimethicone 125 mg
Generic NameSimethicone
Dosage FormTablet, Chewable
Route of AdministrationORAL
Marketing Start Date2019-01-23
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart332
Labeler NameREMEDYREPACK INC.
Substance NameDIMETHICONE
Active Ingredient Strength125 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-1813-0

30 POUCH in 1 BOX, UNIT-DOSE (70518-1813-0) > 1 TABLET, CHEWABLE in 1 POUCH (70518-1813-1)
Marketing Start Date2019-01-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1813-0 [70518181300]

Simethicone 125 mg TABLET, CHEWABLE
Marketing CategoryOTC monograph final
Application Numberpart332
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-01-23

NDC 70518-1813-1 [70518181301]

Simethicone 125 mg TABLET, CHEWABLE
Marketing CategoryOTC monograph final
Application Numberpart332
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-01-23

Drug Details

Active Ingredients

IngredientStrength
DIMETHICONE125 mg/1

OpenFDA Data

SPL SET ID:75309f5a-96bb-4825-8ab5-19d6065248e7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314221

    • NDC Crossover Matching brand name "Simethicone 125 mg" or generic name "Simethicone"

    NDCBrand NameGeneric Name
    69618-032Simethicone 125 mgSimethicone 125 mg
    70518-1813Simethicone 125 mgSimethicone 125 mg
    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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