Home NDC 84415-003 Simethicone Drops
Product NDC 84415-003
11-digit product format 844150003
Labeler code 84415
Product ID 84415-003_5a8782d0-df4d-f78b-e063-6394a90a6127
Type HUMAN OTC DRUG
Nonproprietary name Simethicone Drops
Dosage form LIQUID
Route ORAL
Labeler Everpharm LLC
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-09-01
Substance DIMETHICONE
Active strength 40 mg/.6mL
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 Drops
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 40 mg/.6mL
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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 84415-003-01 84415000301 50 SYRINGE, PLASTIC in 1 CARTON (84415-003-01) / .6 mL in 1 SYRINGE, PLASTIC 2026-09-01 No No Current