Home NDC 17856-1018 SIMETHICONE INFANT
Product NDC 17856-1018
11-digit product format 178561018
Labeler code 17856
Product ID 17856-1018_4d658648-1d31-b0fe-e063-6294a90a0ca6
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form SUSPENSION
Route ORAL
Labeler Atlantic Biologicals Corp.
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 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 SIMETHICONE INFANT
Brand name suffix Gas Relief Drops
Listing expiration 2027-12-31 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17856-1018-1 SIMETHICONE INFANTGas Relief Drops 0.3 mL in 1 SYRINGE SUSPENSION 0.3 1 17856-1018-1 SIMETHICONE INFANTGas Relief Drops 60 in 1 CASE SUSPENSION 60 1 17856-1018-3 SIMETHICONE INFANTGas Relief Drops 60 in 1 CASE SUSPENSION 60 1 17856-1018-3 SIMETHICONE INFANTGas Relief Drops 3 mL in 1 SYRINGE SUSPENSION 3 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 11 of 13 · 242 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 17856-1018-1 17856101801 60 SYRINGE in 1 CASE (17856-1018-1) / .3 mL in 1 SYRINGE 60 syringe 2026-03-16 No No Current 17856-1018-3 17856101803 60 SYRINGE in 1 CASE (17856-1018-3) / 3 mL in 1 SYRINGE 60 syringe 2026-03-16 No No Current