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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
17e181e5-6527-54d0-e063-6294a90addc2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
83324-133-01	ML - Milliliter	83324-133	50d8f59d-d821-455f-aa82-ebb4765ad9c2	1	2025-08-11

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 26 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Regular Strength Antacid Mint	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	Topco Associates, LLC	59c16c09-c23d-4a37-8460-d6c00a268ed5	2024-12-26	Warnings	Exact identifier application number: M001
ANTACID	CALCIUM CARBONATE	Advance Pharmaceutical Inc.	face4e8c-3d0f-4c2e-83c1-44397b225ae7	2024-12-26	Warnings	Exact identifier application number: M001
ANTACID	CALCIUM CARBONATE	Advance Pharmaceutical Inc.	3203dfc5-2cb1-4703-8d81-63fba07ddd98	2024-12-26	Warnings	Exact identifier application number: M001
Magnesium Oxide	MAGNESIUM OXIDE	Richmond Pharmaceuticals, Inc.	9119b7f0-3e8a-7be7-e053-2995a90a4634	2024-12-26	Warnings	Exact identifier application number: M001
Magnesium Oxide	MAGNESIUM OXIDE	Richmond Pharmaceuticals, Inc.	db5941b2-0a04-452a-8fbc-bd5e40fadfb1	2024-12-26	Warnings	Exact identifier application number: M001
HEB Extra Strength Smooth Antacid Assorted Fruits	CALCIUM CARBONATE	H E B	2faac316-7b59-4df8-b751-37069e865263	2024-12-26	Warnings	Exact identifier application number: M001
Good Neighbor Pharmacy Antacid Extra Strength	CALCIUM CARBONATE	AmerisourceBergen Drug Corporation	5e3a3c20-dabe-4427-9e75-99759905caa0	2024-12-26	Warnings	Exact identifier application number: M001
Maximum Strength Antacid Cherry liquid	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	Topco Associates, LLC	31d2e77d-5eda-4f47-917c-3390d6c782af	2024-12-26	Warnings	Exact identifier application number: M001
Maximum Strength Antacid Mint	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	Topco Associates, LLC	50ceff1e-b6df-40f8-89f3-667cc8f9e750	2024-12-26	Warnings	Exact identifier application number: M001
HEB Extra Strength Smooth Antacid Peppermint	CALCIUM CARBONATE	H E B	d04e691e-6d1c-4c39-9504-7ac0f1bd197d	2024-12-26	Warnings	Exact identifier application number: M001
Antacid	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	H E B	f294cf44-fb21-4b2e-8b7c-efd41416c6b2	2024-12-26	Warnings	Exact identifier application number: M001
Antacid	CALCIUM CARBONATE	Trifecta Pharmaceuticals USA LLC	14a7916e-5363-7f1b-e063-6294a90a20aa	2024-12-20	Warnings	Exact identifier application number: M001
maximum strength antacid cherry	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	UNITED NATURAL FOODS, INC. DBA UNFI	d6b49f0a-cf05-4b1b-8cad-c5795aa31645	2024-12-20	Warnings	Exact identifier application number: M001
GOODSENSE Ultra Strength Antacid Peppermint	CALCIUM CARBONATE	GoodSense	04950b56-7760-4b6c-8110-86b6a3f795b4	2024-12-19	Warnings	Exact identifier application number: M001
Goodsense Regular Strength Antacid Peppermint	CALCIUM CARBONATE	GoodSense	32c04f3e-59f3-44aa-ad92-672444982710	2024-12-19	Warnings	Exact identifier application number: M001
GOODSENSE Ultra Strength Antacid Assorted Fruit	CALCIUM CARBONATE	GoodSense	ad4d51f6-b55b-45db-b034-fb3da54fbe99	2024-12-19	Warnings	Exact identifier application number: M001
TUMS Extra Strength Sugar-Free	CALCIUM CARBONATE	Haleon US Holdings LLC	3495102f-55d2-4a94-8d55-f46f49e00c27	2024-12-19	Warnings	Exact identifier application number: M001
Goodsense Extra Strength Antacid Assorted Fruit	CALCIUM CARBONATE	GoodSense	ae6270fc-0f8d-4bba-8f12-adba3f07f7c5	2024-12-19	Warnings	Exact identifier application number: M001
Quality Choice Extra Strength Assorted Berry Antacid Extra strength Assorted Berry Antacid	CALCIUM CARBONATE	Chain Drug Marketing Association Inc.	ec729051-72d3-4d1a-8e39-d4495d5c1cf3	2024-12-18	Warnings	Exact identifier application number: M001
Guardian Extra Strength Antacid	CALCIUM CARBONATE	Guardian Drug Company	aef3d830-c5c3-4f72-86ba-d31945a756db	2024-12-18	Warnings	Exact identifier application number: M001

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
92RU3N3Y1O	DIMETHICONE	9006-65-9	DIMETHICONE

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Quality Choice Infants Non-Staining Gas Relief 520	Chain Drug Marketing Association Inc.	2024-08-23	Human OTC Drug Label	2