Home NDC 85766-302 Simethicone 125 mg
Product NDC 85766-302
11-digit product format 857660302
Labeler code 85766
Product ID 85766-302_5d433805-c22b-bb28-e063-6294a90a826a
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Sportpharm LLC
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
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 7 of 13 · 242 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Curist Gas Relief SIMETHICONE Little Pharma. Inc. 3948c0e5-4ee7-5443-e063-6294a90ad6ae 2025-07-06 Warnings Exact identifier application number: M002 Simethicone 125 mg SIMETHICONE ATLANTIC BIOLOGICALS CORP. 4ce98db3-c7a6-4627-88c5-9de302a53188 2025-06-27 Warnings Exact identifier application number: M002 GNP Regular Strength Gas Relief DIMETHICONE ATLANTIC BIOLOGICALS CORP. b31257ef-489b-4067-9cc6-8a593d983958 2025-06-24 Warnings Exact identifier application number: M002 Gas-X Ultimate Strength Softgels SIMETHICONE Haleon US Holdings LLC 24b777e5-f0b5-400d-8ca9-ae0c04b8503b 2025-05-20 Warnings Exact identifier application number: M002 EXTRA STRENGTH GAS RELIEF SIMETHICONE Geri-Care Pharmaceuticals, Corp b6223134-8a2e-d1ec-e053-2995a90a9077 2025-04-28 Warnings Exact identifier application number: M002 Gas Relief SIMETHICONE 125 MG Pioneer Life Sciences, LLC 21e11fe0-b3b9-42f6-a698-9cdc1a6d82bb 2025-04-23 Warnings Exact identifier application number: M002 Gas Relief SIMETHICONE 125 MG NUVICARE LLC 5c6352b9-fd8a-4876-b089-e4c1d15cd264 2025-04-23 Warnings Exact identifier application number: M002 Gas Relief - Cherry Flavor SIMETHICONE TARGET CORPORATION 290fe08d-a0b9-82f7-e063-6394a90a9c75 2025-04-11 Warnings Exact identifier application number: M002 Infants SIMETHICONE ATLANTIC BIOLOGICALS CORP. 27fce442-e328-41d2-bab9-87ab21550c04 2025-04-11 Warnings Exact identifier application number: M002 Infants Non staining Gas relief SIMETHICONE Retail Business Services, LLC. 1501bee6-4734-4836-8573-54af919d4221 2025-02-27 Warnings Exact identifier application number: M002 Gas-X Extra Strength SIMETHICONE Haleon US Holdings LLC f553374b-c20e-4c92-a8c0-cef0aeda8d1c 2025-02-26 Warnings Exact identifier application number: M002 Extra Strength Gas Relief Cherry Flavor SIMETHICONE Discount Drug Mart, Inc 2df821f6-e4b5-89ae-e063-6394a90ad416 2025-02-24 Warnings Exact identifier application number: M002 Gas relief SIMETHICONE Discount Drug Mart, Inc 2df9117a-97cc-532d-e063-6294a90a1a9c 2025-02-20 Warnings Exact identifier application number: M002 Alcohol prep pad ALCOHOL PREP PAD Target Corporation bc9a4f33-3eec-79e3-e053-2a95a90a9017 2025-02-19 Warnings Exact identifier application number: M002 Ultra Strength Gas Relief SIMETHICONE BETTER LIVING BRANDS, LLC eb4bef2c-15dd-434a-e053-2a95a90a616f 2025-02-12 Warnings Exact identifier application number: M002 Regular Strength Antacid Antigas ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE Harris Teeter, LLC 2c503a99-91da-59f3-e063-6394a90a32ba 2025-02-12 Warnings Exact identifier application number: M002 Ultra Strength Gas Relief SIMETHICONE KROGER COMPANY ea1c4aa8-bde6-2072-e053-2995a90a93ba 2025-02-10 Warnings Exact identifier application number: M002 Gas Relief SIMETHICONE 250 mg Anti-gas SIMETHICONE CVS Pharmacy, Inc. 63dbc39e-2ba8-4435-9093-d1ad2eb3e8d5 2025-02-06 Warnings Exact identifier application number: M002 Extra Strength Gas Relief Cherry SIMETHICONE H E B 1894fa42-4aaf-2d17-e063-6394a90a3962 2025-02-06 Warnings Exact identifier application number: M002 Gas relief SIMETHICONE Guardian Drug Company a5c7c175-1fb7-4b4b-9ba1-b1df1251305c 2025-02-06 Warnings Exact identifier application number: M002
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 85766-302-30 85766030230 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (85766-302-30) 2026-10-07 No No Current 85766-302-60 85766030260 60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (85766-302-60) 2026-10-07 No No Current 85766-302-90 85766030290 90 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (85766-302-90) 2026-10-07 No No Current