Home NDC 82804-043-90 Simethicone 80 mg
Product NDC 82804-043
Requested package NDC 82804-043-90
11-digit product format 828040043
Labeler code 82804
Product ID 82804-043_c27c3d6a-64ca-47d4-bba6-a0c5288e755b
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Proficient Rx LP
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 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 80 mg
Listing expiration 2027-12-31 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82804-043-30 Simethicone 80 mg 30 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 30 2 82804-043-60 Simethicone 80 mg 60 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 60 2 82804-043-90 Simethicone 80 mg 90 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82804-043 SIMETHICONE 80 MG (SIMETHICONE) TABLET, CHEWABLE [PROFICIENT RX LP] 2 Current NDC, 3 package rows 20241024_a5e523b3-475e-4d28-a89c-c4325c59c939.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 8 of 13 · 242 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Extra Strength Gas Relief SIMETHICONE Harris Teeter, LLC 2c3a05de-6690-f49a-e063-6394a90a9085 2025-02-05 Warnings Exact identifier application number: M002 Infants Gas relief SIMETHICONE Harris Teeter, LLC 2c39de90-4896-8a85-e063-6394a90af677 2025-02-05 Warnings Exact identifier application number: M002 Curist Gas Relief Maximum Strength SIMETHICONE Little Pharma, Inc. dc15a8e6-8924-f5c2-e053-2a95a90ab2c0 2025-02-04 Warnings Exact identifier application number: M002 Extra Strength Gas Relief Cherry SIMETHICONE Harris Teeter, LLC 2bd9ebda-520c-691a-e063-6294a90af7d3 2025-02-04 Warnings Exact identifier application number: M002 Extra Strength Gas Relief SIMETHICONE TARGET CORPORATION f6ff3b61-8a47-14ec-e053-6294a90a2df8 2025-01-31 Warnings Exact identifier application number: M002 Gas relief Anti-gas SIMETHICONE CVS 2bc548d2-7176-333b-e063-6394a90aae01 2025-01-29 Warnings Exact identifier application number: M002 Ultrastrength Gas Relief SIMETHICONE SOFT GELATIN CAPSULES CVS PHARMACY, INC 24ceba32-eb30-902f-e063-6394a90a9fd5 2025-01-29 Warnings Exact identifier application number: M002 Extra Strength Gas Relief Cherry Creme SIMETHICONE CVS 2bc522c8-9df0-05b4-e063-6394a90af60c 2025-01-27 Warnings Exact identifier application number: M002 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 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 82804-043-90 82804004390 90 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-043-90) 2023-11-16 No No Current