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 12 of 13 · 242 matching rows.
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