Home NDC 80513-111-12 Gas Relief
Product NDC 80513-111
Requested package NDC 80513-111-12
11-digit product format 805130111
Labeler code 80513
Product ID 80513-111_20e14e1a-beb1-2ad3-e063-6294a90a5565
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 2024-08-30
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 80513-111-12 Gas Relief 120 in 1 BOTTLE CAPSULE, LIQUID FILLED 120 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80513-111 GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [ADVANCED RX LLC] 1 Current NDC, 1 package rows 20240831_72de768c-c011-433b-be27-f1978d18f7d8.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 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 80513-111-12 80513011112 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (80513-111-12) 2024-08-30 No No Current