Home NDC 76162-538 TopCare health EXTRA STRENGTH Gas Relief SOFTGEL
Product NDC 76162-538
11-digit product format 761620538
Labeler code 76162
Product ID 76162-538_3e0ea0d4-f46d-47be-b087-7e4538b22915
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Topco Associates LLC
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-08-01
Substance DIMETHICONE, UNSPECIFIED
Active strength 125 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 TopCare health EXTRA STRENGTH Gas Relief SOFTGEL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE, UNSPECIFIED 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 198852 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 76162-538-05 TopCare health EXTRA STRENGTH Gas Relief SOFTGEL 2 in 1 CARTON CAPSULE, LIQUID FILLED 2 2 76162-538-05 TopCare health EXTRA STRENGTH Gas Relief SOFTGEL 25 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 25 2
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 3 of 13 · 242 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Gas Relief SIMETHICONE CVS PHARMACY, INC 4ff77b4c-9616-4341-9bf8-eca301345a5f 2026-05-21 Warnings Exact identifier application number: M002 Phazyme Ultimate SIMETHICONE C.B. Fleet Company, Inc. c8e9f6ac-2db2-4d21-a4b1-5ca6c3105662 2026-05-20 Warnings Exact identifier application number: M002 gas relief SIMETHICONE United Natural Foods, Inc. dba UNFI 2a82a06d-7511-4fc0-b182-9c1774b2af48 2026-05-15 Warnings Exact identifier application number: M002 Gas Relief SIMETHICONE CVS PHARMACY, INC b114b07e-6822-465a-9e74-2a741ccb19f7 2026-05-14 Warnings Exact identifier application number: M002 Firstcare Gas Relief Simethicone 250 mg Anti-gas SIMETHICONE 250 MG USpharma Ltd 9625a697-fadc-483b-b83a-fa2cc76002ba 2026-05-12 Warnings Exact identifier application number: M002 Firstcare Gas Relief Simethicone 125 mg Anti-gas SIMETHICONE 125 MG USpharma Ltd e92c9661-01f2-42be-af54-42e60efcae35 2026-05-12 Warnings Exact identifier application number: M002 Recuren Plus Antifungal Cream MICONAZOLE NITRATE 2% REGENEREN PLUS LTD 3c28a93a-dd42-65b8-e063-6294a90ae6ab 2026-05-07 Warnings Exact identifier application number: M002 mylanta gas SIMETHICONE Infirst Healthcare ce925db4-fe1a-4069-96be-ce86cdd4e79a 2026-05-01 Warnings Exact identifier application number: M002 PHAZYME SIMETHICONE C.B. Fleet Company, Inc. 3bb5cc1f-554b-4a4d-b9e9-665e34924b4b 2026-04-29 Warnings Exact identifier application number: M002 Childrens Emetrol Multi Symptom Upset Stomach Relief CHILDRENS EMETROL MULTI-SYMPTOM UPSET STOMACH RELIEF WellSpring Pharmaceutical Corporation fe9ccc29-3cca-4666-9bb5-abb41816b3f5 2026-04-23 Warnings Exact identifier application number: M002 Little Remedies Gas Relief Drops SIMTHICONE Medtech Products Inc. 874d3f1d-1e4a-49ab-8285-4d6bf2601d5e 2026-04-23 Warnings Exact identifier application number: M002 good sense gas relief SIMETHICONE Preferred Pharmaceuticals Inc. 06836246-9058-42af-a8a3-5aec81f4b9cc 2026-04-20 Warnings Exact identifier application number: M002 Gas Relief SIMETHICONE Walgreens 52cceb6b-f2c8-49bf-b5ce-5d1c999a9b60 2026-04-17 Warnings Exact identifier application number: M002 Gas Relief Extra Strength SIMETHICONE Best Choice (Valu Merchandisers Company) ce18af91-1c60-44b1-aed2-4f54d394e27e 2026-04-13 Warnings Exact identifier application number: M002 Gas Relief Extra Strength SIMETHICONE H E B c153585f-0f44-40ad-8246-5d9edae8325e 2026-04-02 Warnings Exact identifier application number: M002 ultra strength gas relief SIMETHICONE BIONPHARMA INC. 4e6ac834-9ce3-1b54-e063-6294a90a9dff 2026-04-01 Warnings Exact identifier application number: M002 Extra Strength Gas Relief Cherry SIMETHICONE Good Sense (Geiss, Destin & Dunn, Inc.) 91f72cf2-297d-48db-8f05-f8a7050d92e8 2026-03-31 Warnings Exact identifier application number: M002 Extra Strength Gas Relief SIMETHICONE Hyvee Inc 44ea37b1-8cd2-936d-e063-6394a90a2be7 2026-03-27 Warnings Exact identifier application number: M002 Extra Strength Gas Relief SIMETHICONE Grocery Outlet, Inc. 44672e28-3305-a8cc-e063-6394a90a5fef 2026-03-23 Warnings Exact identifier application number: M002 gas relief SIMETHICONE BIONPHARMA INC. 4d7a9507-6f3c-6d15-e063-6294a90a0160 2026-03-20 Warnings Exact identifier application number: M002
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 76162-538-05 76162053805 2 BLISTER PACK in 1 CARTON (76162-538-05) / 25 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2 blister pack 2025-08-01 No No Current