Home NDC 82804-152 Simethicone 125 mg
Product NDC 82804-152
11-digit product format 828040152
Labeler code 82804
Product ID 82804-152_078ef54e-96b2-4e2f-bebc-9b9bcda1f90a
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 2018-04-25
Substance DIMETHICONE
Active strength 125 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 125 mg
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 125 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 314221 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82804-152-09 Simethicone 125 mg 9 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 9 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82804-152 SIMETHICONE 125 MG (SIMETHICONE) TABLET, CHEWABLE [PROFICIENT RX LP] 1 Current NDC, 1 package rows 20241006_078ef54e-96b2-4e2f-bebc-9b9bcda1f90a.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 6 of 13 · 255 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Gas Relief Extra Strength SIMETHICONE United Natural Foods, Inc. dba UNFI bdd7147b-dcb4-4aa0-a3a1-ec9ceaeec787 2025-11-19 Warnings Exact identifier application number: M002 Gas Relief SIMETHICONE Strategic Sourcing Services LLC fa85df3f-243d-470b-ad28-82512e05fbbe 2025-11-19 Warnings Exact identifier application number: M002 Gas Relief Extra Strength SIMETHICONE P & L Development, LLC 4120832d-6c98-43f6-bdac-c88376c88c30 2025-11-17 Warnings Exact identifier application number: M002 SIMETHICONE SIMETHICONE Geri-Care Pharmaceuticals, Corp be96ce05-dd74-4915-9a8f-2a1b34e2f158 2025-11-17 Warnings Exact identifier application number: M002 Gas Relief Ultra Strength SIMETHICONE P & L Development, LLC cc2dd74a-9cdb-4162-9d05-2b9279f4a38e 2025-11-17 Warnings Exact identifier application number: M002 Gas Relief SIMETHICONE Meijer Distribution, Inc. 7723821e-b2fc-4c9c-a389-05184aaea19f 2025-11-15 Warnings Exact identifier application number: M002 TopCare Extra Strength Gas Relief Cherry Creme SIMETHICONE TOPCO ASSOCIATES LLC 4d1701fd-b797-4e95-9004-84d528941e72 2025-11-10 Warnings Exact identifier application number: M002 up and up extra strength gas relief chewables Extra Strength SIMETHICONE Target Corporation 0a015c48-680c-4de1-91e7-1c1145239d8e 2025-11-04 Warnings Exact identifier application number: M002 Extra Strength Gas Relief SIMETHICONE SAFEWAY c8946bd2-6351-40e4-a139-d8214889bb4e 2025-10-29 Warnings Exact identifier application number: M002 Extra Strength Gas Relief SIMETHICONE ANTIGAS SAFEWAY cbbd43eb-1155-4e0d-bed4-32343f34b503 2025-10-29 Warnings Exact identifier application number: M002 meijer EXTRA STRENGTH Gas Relief SIMETHICONE Meijer, Inc 3e83bb0f-d909-08c3-e063-6294a90ae138 2025-10-29 Warnings Exact identifier application number: M002 PUBLIX Extra Strength SIMETHICONE PUBLIX SUPER MARKETS, INC 089d77c9-7aa0-4eee-8363-c47a2d5928cf 2025-10-28 Warnings Exact identifier application number: M002 Extra Strength gas relief SIMETHICONE PUBLIX SUPER MARKETS, INC, 029f9254-8cfd-4ea0-8691-2d87df450433 2025-10-28 Warnings Exact identifier application number: M002 Publix Infants Dye Free Gas Relief SIMETHICONE PUBLIX SUPER MARKETS, INC 2fe74800-a1f6-4774-9976-d6767ba34b49 2025-10-28 Warnings Exact identifier application number: M002 Extra Strength Gas Relief SIMETHICONE Wal-Mart Stores,Inc., e6087f04-20bf-402c-892b-e64f778b0144 2025-10-27 Warnings Exact identifier application number: M002 Infants Gas Relief Drops SIMETHICONE Wal-Mart Stores,Inc., 966f0506-c2d2-4d3c-bd2d-c5a6b1e0a157 2025-10-27 Warnings Exact identifier application number: M002 Infants SIMETHICONE RUGBY LABORATORIES c6fa71bc-de48-47f4-80c4-7d92643d2664 2025-10-25 Warnings Exact identifier application number: M002 Meijer Extra Strength Gas Relief SIMETHICONE MEIJER DISTRIBUTION INC 1e8dc937-ad86-4560-bcc1-3f23fbfe8c64 2025-10-24 Warnings Exact identifier application number: M002 Meijer Infants Gas Relief Drops SIMETHICONE MEIJER DISTRIBUTION INC. 4493efcd-a547-4700-9e6a-a67d6420edb5 2025-10-24 Warnings Exact identifier application number: M002 PHAZYME SIMETHICONE C.B. Fleet Company, Inc. ea04f5a5-cf56-4176-a234-5a73e01ff218 2025-10-23 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 82804-152-09 82804015209 9 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-152-09) 2024-09-25 No No Current