Home NDC 69452-543-83 ultra strength gas relief
Product NDC 69452-543
Requested package NDC 69452-543-83
11-digit product format 694520543
Labeler code 69452
Product ID 69452-543_4e6ac4e0-d588-99ea-e063-6394a90a6d29
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 180 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 ultra strength gas relief
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 180 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 252294 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 69452-543-83 ultra strength gas relief 300 in 1 BOTTLE CAPSULE, LIQUID FILLED 300 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 69452-543-83 69452054383 300 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-543-83) 2026-04-01 No No Current