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 23 of 34 · 678 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Extra Strength Antacid CALCIUM CARBONATE Discount Drug Mart, Inc 2e0d5be6-d41b-cdf8-e063-6394a90a08b4 2025-02-27 Warnings Exact identifier application number: M001 Supreme Antacid Cherry CALCIUM CARBONATE, MAGNESIUM HYDROXIDE Discount Drug Mart, Inc 2e0a1913-c3d4-7c7d-e063-6294a90a4841 2025-02-26 Warnings Exact identifier application number: M001 Extra Strength sugar free Antacid CALCIUM CARBONATE Discount Drug Mart, Inc 2e09f87b-c771-59ae-e063-6294a90a0c39 2025-02-25 Warnings Exact identifier application number: M001 Ultra Strength Antacid Wintergreen Flavor CALCIUM CARBONATE Xiamen Kang Zhongyuan Biotechnology Co., Ltd. 409b5d06-3398-4414-8919-10b9064ba4ee 2025-02-25 Warnings Exact identifier application number: M001 Extra Strength Antacid Tropical Fruit CALCIUM CARBONATE Discount Drug Mart, Inc 2df92d5c-cd5a-060b-e063-6394a90aa51f 2025-02-25 Warnings Exact identifier application number: M001 Ultra Strength Antacid Assorted Fruit CALCIUM CARBONATE Discount Drug Mart, Inc 2e09cb3b-cf5d-15b1-e063-6394a90a5c6a 2025-02-25 Warnings Exact identifier application number: M001 Extra Strength Smooth Assorted Fruit Antacid CALCIUM CARBONATE Discount Drug Mart, Inc 2df86c35-1e9b-eb49-e063-6294a90aabb6 2025-02-20 Warnings Exact identifier application number: M001 Regular Strength Antacid Regular strength Antacid CALCIUM CARBONATE Discount Drug Mart, Inc 2dfa0de5-6e58-dc9d-e063-6294a90a53e0 2025-02-20 Warnings Exact identifier application number: M001 Childrens Tummy Relief CALCIUM CARBONATE Genexa Inc. f4d39d3e-82d0-2673-e053-2995a90a7d2a 2025-02-20 Warnings Exact identifier application number: M001 Extra Strength Smooth Peppermint Antacid CALCIUM CARBONATE Discount Drug Mart, Inc 2df8fe2b-cc9a-f026-e063-6394a90aa0ad 2025-02-20 Warnings Exact identifier application number: M001 Extra Strength Antacid CALCIUM CARBONATE Harris Teeter, LLC 2cb4ce4e-e18c-c96d-e063-6394a90a18ca 2025-02-20 Warnings Exact identifier application number: M001 Extra Strength Smooth Antacid CALCIUM CARBONATE Harris Teeter, LLC 2cb60b7e-711a-8052-e063-6394a90acf1d 2025-02-20 Warnings Exact identifier application number: M001 Extra Strength Antacid CALCIUM CARBONATE Discount Drug Mart, Inc 2df9e47a-8741-6958-e063-6394a90a6c60 2025-02-20 Warnings Exact identifier application number: M001 Regular Strength Antacid Peppermint CALCIUM CARBONATE Discount Drug Mart, Inc 2e09b8d1-25b4-0e57-e063-6394a90a31e2 2025-02-20 Warnings Exact identifier application number: M001 Tums Chewy Bites Orange and Cream ES CALCIUM CARBONATE Haleon US Holdings LLC 036ef1ed-32ef-46b8-8817-b3f63a014280 2025-02-14 Warnings Exact identifier application number: M001 Tums Naturals CALCIUM CARBONATE Haleon US Holdings LLC d8da54b8-6456-4e7d-acd2-a55e2249bd01 2025-02-13 Warnings Exact identifier application number: M001 Ultra Strength Antacid Assorted Fruit CALCIUM CARBONATE Harris Teeter, LLC 2cb4c58f-ee88-b60e-e063-6294a90a1e6c 2025-02-12 Warnings Exact identifier application number: M001 Maximum Strength Antacid Cherry ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE Harris Teeter, LLC 2c4fc835-a9ad-2666-e063-6394a90a20ac 2025-02-12 Warnings Exact identifier application number: M001 Maximum Strength Antacid ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE Harris Teeter, LLC 2c5081a6-367f-28bc-e063-6294a90a459e 2025-02-12 Warnings Exact identifier application number: M001 Regular Strength Antacid Peppermint CALCIUM CARBONATE Harris Teeter, LLC 2cb54a40-98ce-2660-e063-6294a90a3ed0 2025-02-11 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