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 9 of 13 · 255 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HEB Gas Relief Extra Strength Peppermint SIMETHICONE H E B 52f6db66-ce4c-40dc-b483-6ba83977cd8b 2025-01-20 Warnings Exact identifier application number: M002 Simethicone 125 mg SIMETHICONE Reliable 1 Laboratires LLC 330aed4b-7109-09b8-e054-00144ff8d46c 2025-01-15 Warnings Exact identifier application number: M002 Simethicone 80 mg SIMETHICONE Reliable 1 Laboratories LLC 32fb242b-7051-072c-e054-00144ff88e88 2025-01-15 Warnings Exact identifier application number: M002 ndc (product): 69618-033 SIMETHICONE SIMETHICONE Aphena Pharma Solutions - Tennessee, LLC 5df94be7-0bc9-4be1-9982-8193e3a3c8ef 2025-01-10 Warnings Exact identifier application number: M002 Antiflatulent SIMETHICONE Aphena Pharma Solutions - Tennessee, LLC dd2ca97e-89eb-4940-ac6e-abf1f9e1c6ea 2025-01-10 Warnings Exact identifier application number: M002 Anti-Gas Strip SIMETHICONE Calmour c1576ee9-69ff-41ff-b2d0-7703c8fa8edd 2025-01-09 Warnings Exact identifier application number: M002 Simethicone SIMETHICONE AMZ789 LLC bfaaf4e0-ff87-0fb9-e053-2a95a90a5aa2 2025-01-08 Warnings Exact identifier application number: M002 Simethicone 250mg SIMETHICONE 250MG AMZ789 LLC fcc2ef8b-9181-2c59-e053-6394a90adcc1 2025-01-08 Warnings Exact identifier application number: M002 extra strength Gas Relief cherry creme SIMETHICONE Amerisource Bergen 1e8e8d85-10e2-1273-e063-6394a90a1558 2025-01-08 Warnings Exact identifier application number: M002 Gas Relief SIMETHICONE Advanced Rx LLC 5dcd50ae-370d-4e49-b981-db42b86c2ecb 2025-01-01 Warnings Exact identifier application number: M002 Maximum Strength Gas Relief Softgel SIMETHICONE CVS PHARMACY, INC de059bd9-40de-432d-9370-5d1e53bd89ac 2024-12-30 Warnings Exact identifier application number: M002 Gas Relief SIMETHICONE Topco Associates, LLC c90d68a0-22e1-4a37-8487-16ecdc431ede 2024-12-26 Warnings Exact identifier application number: M002 Simethicone Certified Plus SIMETHICONE Advance Pharmaceutical Inc. d087743f-b82f-2a5c-e053-2995a90abb20 2024-12-26 Warnings Exact identifier application number: M002 GNP Regular Strength Gas Relief DIMETHICONE Amerisource Bergen 7b63b265-e4f2-4103-935c-22d2d89cc5e8 2024-12-26 Warnings Exact identifier application number: M002 Infants Gas relief SIMETHICONE Topco Associates, LLC fd6a2537-8db2-492d-b045-6404df2fb9c3 2024-12-26 Warnings Exact identifier application number: M002 Equaline Stomach Relief BISMUTH SUBSALICYLATE UNITED NATURAL FOODS, INC. DBA UNFI 5dae8bbe-219b-4aa1-bf7f-6471fa2856d9 2024-12-20 Warnings Exact identifier application number: M002 GNP Stomach Relief BISMUTH SUBSALICYLATE 525 MG Amerisource Bergen ead13b6b-de37-49f9-b18e-68096651d47e 2024-12-20 Warnings Exact identifier application number: M002 Infants Gas relief SIMETHICONE UNITED NATURAL FOODS, INC. DBA UNFI a9902ba0-f239-4e66-8d66-7cef39a5fdc3 2024-12-20 Warnings Exact identifier application number: M002 GNP Pink Bismuth BISMUTH SUBSALICYLATE Amerisource Bergen a6ed50d5-574f-4d6b-be48-e14659338993 2024-12-20 Warnings Exact identifier application number: M002 WinCo Foods Gas Relief Extra Strength Softgels SIMETHICONE WinCo Foods, LLC a1a19ef7-4a14-4fcb-8917-631d867be0bb 2024-12-18 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