NDC 70000-0434

Leader Gas relief

Simethicone

Leader Gas relief is a Oral Tablet, Chewable in the Human Otc Drug category. It is labeled and distributed by Cardinal Health 110, Llc. Dba Leader. The primary component is Dimethicone.

Product ID70000-0434_45569495-dac6-44ea-b3bb-f3f18000e734
NDC70000-0434
Product TypeHuman Otc Drug
Proprietary NameLeader Gas relief
Generic NameSimethicone
Dosage FormTablet, Chewable
Route of AdministrationORAL
Marketing Start Date2019-06-07
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart332
Labeler NameCARDINAL HEALTH 110, LLC. DBA LEADER
Substance NameDIMETHICONE
Active Ingredient Strength80 mg/1
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 70000-0434-1

100 TABLET, CHEWABLE in 1 BOTTLE (70000-0434-1)
Marketing Start Date2019-06-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70000-0434-1 [70000043401]

Leader Gas relief TABLET, CHEWABLE
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart332
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2019-06-07

Drug Details

Active Ingredients

IngredientStrength
DIMETHICONE80 mg/1

OpenFDA Data

SPL SET ID:0163d372-222e-4a8d-a5cb-5a7af9a7068c
Manufacturer
UNII

NDC Crossover Matching brand name "Leader Gas relief" or generic name "Simethicone"

NDCBrand NameGeneric Name
70000-0434Leader Gas reliefLeader Gas relief
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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.