Home NDC 69452-542 gas relief
Product NDC 69452-542
11-digit product format 694520542
Labeler code 69452
Product ID 69452-542_4d7a9507-6f3d-6d15-e063-6294a90a0160
Type HUMAN OTC DRUG
Nonproprietary name simethicone
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler BIONPHARMA INC.
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-04-01
Substance DIMETHICONE
Active strength 125 mg/1
Pharmacologic classes Skin Barrier Activity [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 gas relief
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 125 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 198852 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69452-542-28 gas relief 250 in 1 BOTTLE CAPSULE, LIQUID FILLED 250 1
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 1 of 13 · 255 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 69452-542-28 69452054228 250 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-542-28) 2026-04-01 No No Current