Home NDC 55154-2606 SIMETHICONE 80MG
Product NDC 55154-2606
11-digit product format 551542606
Labeler code 55154
Product ID 55154-2606_1c767028-e9e1-4b7b-8cf1-73497b854034
Type HUMAN OTC DRUG
Nonproprietary name SIMETHICONE
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Cardinal Health 107, LLC
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-10-01
Substance DIMETHICONE, UNSPECIFIED
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 80MG
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE, UNSPECIFIED 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55154-2606-0 SIMETHICONE 80MG 1 in 1 BLISTER PACK TABLET, CHEWABLE 1 3 55154-2606-0 SIMETHICONE 80MG 10 in 1 BAG TABLET, CHEWABLE 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55154-2606 SIMETHICONE 80MG (SIMETHICONE) TABLET, CHEWABLE [CARDINAL HEALTH 107, LLC] 1 Current NDC, 2 package rows 20241003_5e755184-0821-4f92-8f72-84726f7aa407.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 12 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 55154-2606-0 55154260600 10 BLISTER PACK in 1 BAG (55154-2606-0) / 1 TABLET, CHEWABLE in 1 BLISTER PACK 10 blister pack 2024-10-01 No No Current