Home NDC 70000-0434 Leader Gas relief
Product NDC 70000-0434
11-digit product format 700000434
Labeler code 70000
Product ID 70000-0434_c598e7be-e58f-4812-8a05-f03d9303053b
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler CARDINAL HEALTH 110, LLC. DBA LEADER
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-06-07
Substance DIMETHICONE
Active strength 80 mg/1
Pharmacologic classes Skin Barrier Activity [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Leader Gas relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 80 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 92RU3N3Y1O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 314216 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70000-0434-1 Leader Gas relief 100 in 1 BOTTLE TABLET, CHEWABLE 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0434 LEADER GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [CARDINAL HEALTH 110, LLC. DBA LEADER] 4 Current NDC, Legacy NDC, 1 package rows 20241219_0163d372-222e-4a8d-a5cb-5a7af9a7068c.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 5 of 13 · 242 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70000-0434-1 70000043401 100 TABLET, CHEWABLE in 1 BOTTLE (70000-0434-1) 2019-06-07 0000-00-00 No No Current