Home NDC 69618-033 Simethicone 80 mg
Product NDC 69618-033
11-digit product format 696180033
Labeler code 69618
Product ID 69618-033_2bc83c5b-6b22-871b-e063-6294a90adbc4
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Reliable 1 Laboratories LLC
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-04-24
Substance DIMETHICONE
Active strength 80 mg/1
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 80 mg
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 80 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 314216 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69618-033-01 Simethicone 80 mg 100 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 100 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69618-033 SIMETHICONE 80 MG (SIMETHICONE) TABLET, CHEWABLE [RELIABLE 1 LABORATORIES LLC] 12 Current NDC, Legacy NDC, 1 package rows 20250117_32fb242b-7051-072c-e054-00144ff88e88.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 13 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 69618-033-01 69618003301 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (69618-033-01) 2018-04-24 0000-00-00 No No Current