Home NDC 46122-547 INFANT GAS RELIEF
Product NDC 46122-547
11-digit product format 461220547
Labeler code 46122
Product ID 46122-547_00c51ee1-d7ea-17f1-e063-6394a90ac336
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form SUSPENSION/ DROPS
Route ORAL
Labeler AMERISOURCEBERGEN DRUG CORPORATION
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-06-01
Substance DIMETHICONE
Active strength 20 mg/.3mL
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 INFANT GAS RELIEF
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 20 mg/.3mL
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 198857 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 46122-547-03 INFANT GAS RELIEF 30 mL in 1 BOTTLE, DROPPER SUSPENSION/ DROPS 30 4 46122-547-03 INFANT GAS RELIEF 1 in 1 CARTON SUSPENSION/ DROPS 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46122-547 INFANT GAS RELIEF (SIMETHICONE) SUSPENSION/ DROPS [AMERISOURCEBERGEN DRUG CORPORATION] 4 Current NDC, Legacy NDC, 2 package rows 20231102_7d3c3cc6-b0a2-620d-e053-2a91aa0a159b.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 Marketing end Sample Exclude flag Status 46122-547-03 46122054703 1 BOTTLE, DROPPER in 1 CARTON (46122-547-03) / 30 mL in 1 BOTTLE, DROPPER 2018-11-16 0000-00-00 No No Current