Home NDC 83059-0076 Extra Strength Gas Relief
Product NDC 83059-0076
11-digit product format 830590076
Labeler code 83059
Product ID 83059-0076_5a0cad89-765d-b11b-e063-6294a90adfdb
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Shield Pharmaceuticals Corp
Application M001
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-08-27
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 Extra Strength Gas Relief
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 198852 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 36 · 719 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Rolaids Ultra Strength Antacid Strawberry CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE Chattem, Inc. f4a91efc-2d81-4605-8178-d36ab6c71563 2026-01-14 Warnings Exact identifier application number: M001 D-D SUDIUM BICARBONATE U.S.P. BICARBONATO DE SODA PURO SODIUM BICARBONATE Evi Labs 485f9eb1-6535-c47c-e063-6394a90ae32c 2026-01-14 Warnings Exact identifier application number: M001 Rolaids Extra Strength Fruit CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE Chattem, Inc. ce2af1a6-0387-41e5-ad06-85b790bd4120 2026-01-14 Warnings Exact identifier application number: M001 Rolaids Ultra Strength Mint CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE Chattem, Inc. 8806c912-ab83-4f45-ac78-e826bb3143d4 2026-01-14 Warnings Exact identifier application number: M001 Rolaids Advanced Antacid Anti-gas Wild Berry CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE AND SIMETHICONE Chattem, Inc. 07649a83-0123-4bb5-b130-3067c7d052c5 2026-01-14 Warnings Exact identifier application number: M001 CVS Health Extra Strength Sugar Free Antacid ANTACID CVS Pharmacy,Inc. f722e7ce-6cca-4850-a230-7510c7ca7754 2026-01-12 Warnings Exact identifier application number: M001 MGC Health Calcium Carbonate Antacid Assorted Fruits CALCIUM CARBONATE Medical Group Care LLC 47e1a46c-5665-ac4c-e063-6294a90a9b81 2026-01-08 Warnings Exact identifier application number: M001 MGC Health Calcium Carbonate Antacid Assorted Fruits CALCIUM CARBONATE Medical Group Care LLC 47e19b30-3784-ad98-e063-6294a90aa566 2026-01-08 Warnings Exact identifier application number: M001 MGC Health Calcium Carbonate Antacid Tropical Fruit CALCIUM CARBONATE Medical Group Care LLC 47e1bc32-baf5-ad9a-e063-6294a90ad5b4 2026-01-08 Warnings Exact identifier application number: M001 MGC Health Calcium Carbonate Antacid Assorted Berries CALCIUM CARBONATE Medical Group Care LLC 47e1c7c7-4f3b-c04b-e063-6394a90a775f 2026-01-08 Warnings Exact identifier application number: M001 Sanar Baking Soda 8oz 100% pure SODIUM BICARBONATE Evi Labs 47e7f801-3176-288c-e063-6394a90abef4 2026-01-08 Warnings Exact identifier application number: M001 Xpect Antacid CALCIUM CARBONATE Cintas Corporation 3ef4eac7-cc9d-4ee2-b93a-59b85dbc6e7c 2026-01-08 Warnings Exact identifier application number: M001 DR. SANA BICARBONATO DE SODIO 4 Fl oz and 6 Floz SODIUM BICARBONATE Evi Labs 47330d09-7db1-254d-e063-6294a90ae7de 2026-01-07 Warnings Exact identifier application number: M001 DE LA CRUZ SODIUM BICARBONATE ANTACID SODIUM BICARBONATE DLC Laboratories, Inc. fc469943-9749-45ee-93f7-90fdbcdc7215 2026-01-07 Warnings Exact identifier application number: M001 De La Cruz Desempacho SODIUM BICARBONATE DLC LABORATORIES, INC. 741e105a-3ed2-4fc7-ab06-273e515a2d16 2026-01-07 Warnings Exact identifier application number: M001 ANTACID AND ANTIGAS CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONE Geri-Care Pharmaceuticals, Corp 472eafe8-aa7a-f435-e063-6294a90acf6b 2025-12-30 Warnings Exact identifier application number: M001 ANTACID AND ANTIGAS CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONE Geri-Care Pharmaceuticals, Corp 472f5bfc-c676-56da-e063-6294a90a74af 2025-12-30 Warnings Exact identifier application number: M001 ANTACID AND ANTIGAS CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONE Geri-Care Pharmaceuticals, Corp 472ffa66-938f-14e7-e063-6394a90ad0ca 2025-12-30 Warnings Exact identifier application number: M001 QC Ultra Strength Antacid Soft Chews, Cherry QC ANTACID SOFT CHEWS, CHERRY Xiamen Kang Zhongyuan Biotechnology Co., Ltd. 26a97517-d3e7-d896-e063-6394a90acc95 2025-12-29 Warnings Exact identifier application number: M001 Tums Chewy Bites CALCIUM CARBONATE Select Consumer Group 3caa037e-3424-f9ce-e063-6294a90ac1e8 2025-12-27 Warnings Exact identifier application number: M001