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 9 of 13 · 242 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 Discount Drugmart Gas Relief Extra Strength Softgels SIMETHICONE Discount Drug Mart, Inc 63f3e5f0-10da-4681-a4f1-8ca1eb7e390f 2024-12-18 Warnings Exact identifier application number: M002 Quality Choice Gas Relief Extra Strength Softgels SIMETHICONE Chain Drug Marketing Association 06dfb541-fd1f-4cee-a4a6-44252f1f65a0 2024-12-18 Warnings Exact identifier application number: M002 Leader Gas relief SIMETHICONE CARDINAL HEALTH 110, LLC. DBA LEADER 0163d372-222e-4a8d-a5cb-5a7af9a7068c 2024-12-17 Warnings Exact identifier application number: M002 Maximum Strength Gas Relief Softgel-60ct SIMETHICONE HEB f65e362a-2f90-428a-b885-eefdad8cae1e 2024-12-16 Warnings Exact identifier application number: M002 Maximum Strength Gas Relief SIMETHICONE Chain Drug Marketing Association, Inc. e8b2c528-121d-519a-e053-2a95a90a4119 2024-12-16 Warnings Exact identifier application number: M002 Gas Relief Ultra Strength DIMETHICONE TOPCO ASSOCIATES LLC b9a4c876-722b-4d6c-807f-005ccf5df320 2024-12-14 Warnings Exact identifier application number: M002 Gas Relief Extra Strength DIMETHICONE TOPCO ASSOCIATES LLC bb1c54d4-3a36-4b77-8659-2e92845d2f0e 2024-12-14 Warnings Exact identifier application number: M002 Foster and Thrive Extra Strength Gas Relief Cherry SIMETHICONE Strategic Sourcing Services LLC e47374c8-05c1-4874-871b-e83d9b305bd3 2024-12-13 Warnings Exact identifier application number: M002 Gas-X Extra Strength SIMETHICONE Haleon US Holdings LLC 7ce312ca-542b-4bc0-97b5-f65279e1e84c 2024-12-13 Warnings Exact identifier application number: M002 Antacid Antigas ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE Retail Business Services, LLC. c8173d42-f900-4527-aa56-472d1177a9bc 2024-12-11 Warnings Exact identifier application number: M002 Simethicone SIMETHICONE Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd 0c9c5fec-ddd4-41a5-8ff9-6b55c376dd36 2024-11-25 Warnings Exact identifier application number: M002 Simethicone SIMETHICONE Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. f7c40b12-11e4-4b85-afb2-0ea33e4f218c 2024-11-25 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