Home NDC 80513-119 Gas Relief
Product NDC 80513-119
11-digit product format 805130119
Labeler code 80513
Product ID 80513-119_4b13d80d-b9c0-6dee-e063-6294a90aab41
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Advanced Rx LLC
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-02-01
Substance DIMETHICONE, UNSPECIFIED
Active strength 500 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
Brand name suffix Ultimate Strength Softgels
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE, UNSPECIFIED 500 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 2477951 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 80513-119-01 Gas ReliefUltimate Strength Softgels 100 in 1 BOTTLE CAPSULE, LIQUID FILLED 100 1 80513-119-50 Gas ReliefUltimate Strength Softgels 50 in 1 BOTTLE CAPSULE, LIQUID FILLED 50 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 80513-119-01 80513011901 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (80513-119-01) 2026-02-01 No No Current 80513-119-50 80513011950 50 CAPSULE, LIQUID FILLED in 1 BOTTLE (80513-119-50) 2026-02-01 No No Current