Home NDC 83324-133 Quality Choice Infants Non-staining Gas relief
Product NDC 83324-133
11-digit product format 833240133
Labeler code 83324
Product ID 83324-133_90e2b49f-a358-4228-9b0c-130ebafd5640
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form SOLUTION/ DROPS
Route ORAL
Labeler Chain Drug Marketing Association Inc.
Application M001
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-08-21
Substance DIMETHICONE
Active strength 20 mg/.3mL
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 Quality Choice Infants Non-staining Gas relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 20 mg/.3mL
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 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 83324-133-01 Quality Choice Infants Non-staining Gas relief 30 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 30 2 83324-133-01 Quality Choice Infants Non-staining Gas relief 1 in 1 CARTON SOLUTION/ DROPS 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83324-133 QUALITY CHOICE INFANTS NON-STAINING GAS RELIEF (SIMETHICONE) SOLUTION/ DROPS [CHAIN DRUG MARKETING ASSOCIATION INC.] 2 Current NDC, 2 package rows 20240824_17e181e5-6527-54d0-e063-6294a90addc2.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 18 of 34 · 678 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Extra Strength Smooth Antacid ANTACID TABLETS Wal-Mart Stores,Inc., 92372491-000d-4273-a668-b87722c1d381 2025-10-27 Warnings Exact identifier application number: M001 equate Extra Strength Smooth Antacid Assorted Berries ANTACID TABLETS Wal-Mart Stores,Inc., cc93e3b4-adbc-4a2c-b6fc-bf7456ef1656 2025-10-27 Warnings Exact identifier application number: M001 Magnesium Oxide MAGNESIUM OXIDE Kesin Pharma 31f417f0-1637-eefa-e063-6294a90a121b 2025-10-27 Warnings Exact identifier application number: M001 Rugby Extra Strength Assorted Berries ANTACID TABLETS Rugby Laboratories b0fcfd66-276e-4741-9aee-915b6364f25c 2025-10-25 Warnings Exact identifier application number: M001 Rugby ANTACID TABLETS Rugby Laboratories 9cb56bc3-7075-4f81-bd10-7e602034b7d8 2025-10-25 Warnings Exact identifier application number: M001 Rugby Cal-Gest Antacid Assorted Flavors ANTACID TABLETS Rugby Laboratories, Inc. a43184c4-d225-4539-b651-4d96535f208f 2025-10-25 Warnings Exact identifier application number: M001 Super vitamin C serum SUPER VITAMIN C FlexiGo Inc 41cbe84e-3ddf-b806-e063-6294a90a55a4 2025-10-22 Warnings Exact identifier application number: M001 Exchange Select Antacid Soft Chews Cherry Flavor CALCIUM CARBONATE Army & Air Force Exchange Service 41ad5581-5b8a-1c8b-e063-6294a90a2ba6 2025-10-21 Warnings Exact identifier application number: M001 Magnesium Oxide MAGNESIUM OXIDE Method Pharmaceuticals, LLC 0af63651-f9d9-43b9-b6f0-4878466a82e6 2025-10-21 Warnings Exact identifier application number: M001 CardinalExtra Strength Antacid Wintergreen flavor CALCIUM CARBONATE CARDINAL HEALTH 4e40989f-c710-442a-bb8d-02e813ddf04d 2025-10-14 Warnings Exact identifier application number: M001 Regular Strength Antacid Assorted Fruit CALCIUM CARBONATE CARDINAL HEALTH def9eaef-308f-49f2-898b-469c2c395d27 2025-10-14 Warnings Exact identifier application number: M001 Leader Extra Strength Sugar Free Antacid ANTACID Cardinal Health d7a6f1b8-bdf7-45bb-bab0-b22f45e78440 2025-10-14 Warnings Exact identifier application number: M001 Extra Strength Antacid Original Flavor ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE Cardinal Health 1fe459f6-be7f-4c59-b33b-f13ec17071f2 2025-10-14 Warnings Exact identifier application number: M001 Cardinal Extra Strength Smooth Antacid Assorted Fruits CALCIUM CARBONATE CARDINAL HEALTH 84bf7fea-a071-4583-9453-1aea4d198ca6 2025-10-14 Warnings Exact identifier application number: M001 ANTACID Extra Strength CALCIUM CARBONATE Cardinal Health 110, LLC. 3ce9b97b-1680-4299-9a2c-132318adbc0c 2025-10-14 Warnings Exact identifier application number: M001 ANTACID Extra Strength CALCIUM CARBONATE CARDINAL HEALTH 110, LLC. 7c1b2ee6-b691-4c12-bed5-f0a360ad46bb 2025-10-14 Warnings Exact identifier application number: M001 ANTACID Ultra Strength CALCIUM CARBONATE CARDINAL HEALTH 110, LLC. d267ca31-09bd-46d3-be08-a259642f1b7f 2025-10-14 Warnings Exact identifier application number: M001 Magnesium Oxide MAGNESIUM OXIDE A-S Medication Solutions c14d2b4d-d6d8-4293-835e-5d893d5b7e6a 2025-10-10 Warnings Exact identifier application number: M001 Calcium Carbonate Antacid Assorted Berries CALCIUM CARBONATE Xiamen Kang Zhongyuan Biotechnology Co., Ltd. 3f640ccd-4b8d-fc24-e063-6294a90a6e58 2025-09-22 Warnings Exact identifier application number: M001 Stomachin Antacid MAGNESIUM CARBONATE AND SODIUM BICARBONATE Chang Kuo Chou Pharmaceutical Co., Ltd. 60fa0650-8785-4cb3-8f88-1a437296252f 2025-09-19 Warnings Exact identifier application number: M001
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 83324-133-01 83324013301 1 BOTTLE, DROPPER in 1 CARTON (83324-133-01) / 30 mL in 1 BOTTLE, DROPPER 2024-08-21 No No Current