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 11 of 13 · 255 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Simethicone SIMETHICONE WALGREEN CO. 4d523979-e3ae-47e8-9092-00fdffc8bb0b 2024-11-21 Warnings Exact identifier application number: M002 Gas Relief SIMETHICONE Wal-Mart Stores Inc 69351cf9-3092-45ca-8b84-83e3737fa8d4 2024-11-21 Warnings Exact identifier application number: M002 Simethicone SIMETHICONE WALMART INC. 79a9e0a3-9199-4397-ab29-b8a9c843cdf8 2024-11-21 Warnings Exact identifier application number: M002 Maximum Strength Gas Relief SIMETHICONE FOODHOLD U.S.A., LLC c37def6e-bb10-41ba-8bce-b06c09edbe9f 2024-11-21 Warnings Exact identifier application number: M002 Gas Relief Ultra Strength SIMETHICONE 180 MG Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. 2cfb8132-6de4-457d-880b-c870a38862ad 2024-11-20 Warnings Exact identifier application number: M002 Gas-Aid SIMETHICONE Leosons Overseas Corp d271bfcb-bf13-4a97-bc03-f1824826f15a 2024-11-19 Warnings Exact identifier application number: M002 Gas-Aid Drops for infants SIMETHICONE Leosons Overseas Corp 06665701-5f1c-4f8f-8775-e0a4a9ef2029 2024-11-19 Warnings Exact identifier application number: M002 Mag-AL Plus XS ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND DIMETHICONE PAI Holdings, LLC dba PAI Pharma db0c47ab-5296-4195-9fa6-2e338b665094 2024-11-12 Warnings Exact identifier application number: M002 basic care gas relief SIMETHICONE Amazon.com Services LLC ab1681df-aded-4b0c-9124-87196606183b 2024-11-02 Warnings Exact identifier application number: M002 Good Sense Gas Relief Extra Strength SIMETHICONE L. Perrigo Company 6b2d8591-cc58-457e-92b6-c719eee85605 2024-11-02 Warnings Exact identifier application number: M002 premier value infants gas relief SIMETHICONE Chain Drug Consortium 7b887e53-a70a-4f33-9472-e1175b24400a 2024-10-28 Warnings Exact identifier application number: M002 Premier Value Extra Strength SIMETHICONE PHARMACY VALUE ALLIANCE, LLC df2b1b62-5bd2-4d02-86c2-537b965a8d20 2024-10-28 Warnings Exact identifier application number: M002 Simethicone 80 mg SIMETHICONE Proficient Rx LP a5e523b3-475e-4d28-a89c-c4325c59c939 2024-10-01 Warnings Exact identifier application number: M002 good sense gas relief SIMETHICONE L. Perrigo Company 14caaf5a-6877-40f9-af8f-fb48de94ecfe 2024-09-30 Warnings Exact identifier application number: M002 Care One Gas Relief SIMETHICONE American Sales Company f42c8c2a-4ffd-465e-bb93-05ed65ba76f0 2024-09-15 Warnings Exact identifier application number: M002 Gas Relief SIMETHICONE Publix Super Markets Inc aafa7da9-53d7-478a-805e-e68cdf54ed2b 2024-09-14 Warnings Exact identifier application number: M002 basic care gas relief SIMETHICONE Amazon.com Services LLC 6cd13797-207b-41fa-8dc1-5688f6b86149 2024-09-14 Warnings Exact identifier application number: M002 meijer EXTRA STRENGTH Gas Relief SOFTGEL SIMETHICONE Meijer, Inc. 1befc6cb-a5ad-b950-e063-6394a90a5de3 2024-09-12 Warnings Exact identifier application number: M002 meijer ULTRA STRENGTH Gas Relief SOFTGEL SIMETHICONE Meijer, Inc. 1bdbea4c-52f6-f855-e063-6394a90ae4fc 2024-09-06 Warnings Exact identifier application number: M002 Simethicone 125 mg SIMETHICONE Proficient Rx LP 078ef54e-96b2-4e2f-bebc-9b9bcda1f90a 2024-09-01 Warnings Exact identifier application number: M002
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