Home NDC 82568-0017 SIMETHICONE INFANT
Product NDC 82568-0017
11-digit product format 825680017
Labeler code 82568
Product ID 82568-0017_3b14f103-c7f9-f905-e063-6294a90a0e2c
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form SUSPENSION
Route ORAL
Labeler AARNA USA Inc.
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-02-20
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 SIMETHICONE INFANT
Brand name suffix Gas Relief Drops
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 82568-0017-3 SIMETHICONE INFANTGas Relief Drops 1 in 1 PACKAGE SUSPENSION 1 3 82568-0017-3 SIMETHICONE INFANTGas Relief Drops 30 mL in 1 BOTTLE SUSPENSION 30 3 82568-0017-4 SIMETHICONE INFANTGas Relief Drops 118 mL in 1 BOTTLE SUSPENSION 118 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82568-0017 SIMETHICONE INFANT GAS RELIEF DROPS (SIMETHICONE) SUSPENSION [AARNA USA INC.] 1 Current NDC, 3 package rows 20250303_9b0fde90-35ae-498e-99cc-d120f1a87182.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 5 of 13 · 241 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82568-0017-3 82568001703 1 BOTTLE in 1 PACKAGE (82568-0017-3) / 30 mL in 1 BOTTLE 1 bottle 2025-02-20 No No Current 82568-0017-4 82568001704 118 mL in 1 BOTTLE (82568-0017-4) 118 ml 2025-02-20 No No Current