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 25 of 34 · 678 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Calcium Carbonate 1250 mg CALCIUM CARBONATE CitraGen Pharmaceuticals, Inc. 766b3f3f-8bd1-281c-e053-2991aa0af54b 2025-01-30 Warnings Exact identifier application number: M001 Calcium Carbonate 10 gr (648 mg) CALCIUM CARBONATE CitraGen Pharmaceuticals, Inc. 723b940d-4f4b-f2e6-e053-2991aa0a8bcc 2025-01-30 Warnings Exact identifier application number: M001 Ultra Strength Antacid CALCIUM CARBONATE CVS 2bc4c71c-a9c5-17df-e063-6294a90ac88c 2025-01-27 Warnings Exact identifier application number: M001 Goodsense Ultra Strength Antacid CALCIUM CARBONATE Good Sense (Geiss, Destin & Dunn, Inc.) 492deace-7ea1-4fe3-a4c7-b2c6f195d68c 2025-01-20 Warnings Exact identifier application number: M001 Calcium Carbonate 10 gr (648 mg) (Antacid) CALCIUM CARBONATE 10GR (648 MG) Ulai Health LLC 641ae5b9-3bb6-41a1-ab12-367bf2fbcb0a 2025-01-20 Warnings Exact identifier application number: M001 GoodSense Extra Strength Antacid CALCIUM CARBONATE GoodSense 2fcdeb06-17de-49d8-97bb-8d31e1c0c61f 2025-01-20 Warnings Exact identifier application number: M001 HEB Extra Stregth Antacid CALCIUM CARBONATE H E B dcfe4c81-b6e0-4a9b-a521-f3ad0c0a8e48 2025-01-20 Warnings Exact identifier application number: M001 Aluminum Hydroxide, Magnesium Hydroxide and Simethicone ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE Everpharm LLC 2bda74cb-e77d-46bb-e063-6394a90af580 2025-01-16 Warnings Exact identifier application number: M001 Childrens Antacid CALCIUM CARBONATE CVS 1bf90c0c-b639-1c06-e063-6394a90ab85b 2025-01-16 Warnings Exact identifier application number: M001 Sodium Bicarbonate SODIUM BICARBONATE World Perfumes Inc a83544e4-ec09-1e95-e053-2995a90ab7b9 2025-01-15 Warnings Exact identifier application number: M001 Sodium Bicarbonate 10 gr SODIUM BICARBONATE Reliable 1 Laboratories LLC 321a772c-c44c-3d4e-e054-00144ff8d46c 2025-01-15 Warnings Exact identifier application number: M001 Calcium Carbonate 500 mg CALCIUM CARBONATE Reliable 1 Laboratories LLC 322f1b54-abe9-11a7-e054-00144ff8d46c 2025-01-15 Warnings Exact identifier application number: M001 Soothe Chewable CITRIC ACID Carolina Cannabis Creations LLC 04a27a71-b7b2-12aa-e063-6294a90a312f 2025-01-15 Warnings Exact identifier application number: M001 Soothe Chewable CITRIC ACID Carolina Cannabis Creations LLC 04a7720f-1e74-7578-e063-6394a90a5eae 2025-01-15 Warnings Exact identifier application number: M001 Soothe Chewable CITRIC ACID Carolina Cannabis Creations LLC 04a78060-7f0d-c4bd-e063-6294a90ae152 2025-01-15 Warnings Exact identifier application number: M001 Soothe Chewable CITRIC ACID Carolina Cannabis Creations LLC 04a78a5c-e3b5-f362-e063-6394a90a0807 2025-01-15 Warnings Exact identifier application number: M001 Rolaids Extra Strength Mint CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE Chattem, Inc. 604d79f3-cdfa-45e2-8c20-fa6e0ff09b2e 2025-01-15 Warnings Exact identifier application number: M001 Extra Strength Smooth Antacid CALCIUM CARBONATE H E B 19a3221f-e0c1-c47a-e063-6394a90a1f01 2025-01-14 Warnings Exact identifier application number: M001 Childrens Stomach Relief Antacid CALCIUM CARBONATE H E B 18fae1aa-1001-8035-e063-6394a90adc66 2025-01-14 Warnings Exact identifier application number: M001 Calcium Carbonate 10 gr (648 mg) (Antacid) CALCIUM CARBONATE 10GR (648 MG) Aphena Pharma Solutions - Tennessee, LLC ac839363-94fd-4c60-b5b6-70e4488ce1dd 2025-01-09 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