FDA.reportPublic FDA data

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
IngredientStrength
DIMETHICONE20 mg/.3mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92RU3N3Y1OInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
17e181e5-6527-54d0-e063-6294a90addc2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-133-01Quality Choice Infants Non-staining Gas relief30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS302
83324-133-01Quality Choice Infants Non-staining Gas relief1 in 1 CARTONSOLUTION/ DROPS12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-133-01ML - Milliliter83324-13350d8f59d-d821-455f-aa82-ebb4765ad9c212025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-133QUALITY CHOICE INFANTS NON-STAINING GAS RELIEF (SIMETHICONE) SOLUTION/ DROPS [CHAIN DRUG MARKETING ASSOCIATION INC.]2Current NDC, 2 package rows20240824_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 2 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kroger Extra Strength Sugar FreeCALCIUM CARBONATEKROGER COMPANY3f737ce2-961e-4bd0-ae6d-078248cf1c672026-08-31WarningsExact identifier
application number: M001
Kroger Extra Strength Assorted BerryCALCIUM CARBONATEKROGER COMPANYfa191237-d230-4528-8dff-50e8d5c65b6d2026-08-31WarningsExact identifier
application number: M001
Kroger Ultra Strength Assorted BerryCALCIUM CARBONATEKROGER COMPANYb7db77a7-0580-455b-a2ef-a68584f039812026-08-31WarningsExact identifier
application number: M001
Ultra Strength Natural AntacidCALCIUM CARBONATEKROGER COMPANY2931d427-b2be-4db9-a58d-ff89c221ff512026-08-31WarningsExact identifier
application number: M001
Ultra Strength AntacidANTACID TABLETSTHE KROGER CO.,f5d82d1b-2f75-4af4-8337-a5bd28c26fb72026-08-31WarningsExact identifier
application number: M001
Kroger Extra Strength Assorted FruitCALCIUM CARBONATEKROGER COMPANY486d7a5f-cbc8-4f86-b12e-c5325bd8c62d2026-08-31WarningsExact identifier
application number: M001
GERI-LANTA MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEPreferred Pharmaceuticals Inc.3b049027-30ac-4c78-a4f1-8191f7ed45bf2026-08-27WarningsExact identifier
application number: M001
Extra Strength Gas ReliefSIMETHICONEShield Pharmaceuticals Corp534144be-fcaf-400d-b772-595c62ae6ea62026-08-27WarningsExact identifier
application number: M001
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEGuardian Drug Company48ec50ab-f24b-367b-e063-6294a90ad7362026-08-27WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEKROGER COMPANYb9e61a03-e008-50ab-e053-2a95a90a32102026-08-26WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS PHARMACYaf71e02d-e7c7-f925-e053-2995a90a08612026-08-26WarningsExact identifier
application number: M001
Tumeez Organic AppleCALCIUM CARBONATEBFY LLCf561685a-5260-59c6-e053-2a95a90ae2062026-08-25WarningsExact identifier
application number: M001
Dr. Sana Lemon Alivio Digestivo UPSET STOMACHEFFERVESCENT ANTACIDEVI LABS59cdf417-e5c0-6bb2-e063-6294a90a9c512026-08-24WarningsExact identifier
application number: M001
Dr Sana Alivio Digestivo Naranja UPSET STOMACHEFFERVESCENT ANTACIDEVI LABS59d07c2d-ef11-bd32-e063-6394a90af87d2026-08-24WarningsExact identifier
application number: M001
Genexa Antacid Maximum StrengthCALCIUM CARBONATEGenexa Inc.3a39d91c-2dcd-71d6-e063-6394a90a54742026-08-22WarningsExact identifier
application number: M001
Mag-AL PlusALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEPAI Holdings, LLC dba PAI Pharma896ab07a-1b40-43ab-8589-3be86b1c41982026-08-19WarningsExact identifier
application number: M001
CVS Health Extra Strength AntacidALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECVS PHARMACY8629529e-4363-4d37-9ae0-27193868df322026-08-19WarningsExact identifier
application number: M001
Mylanta Fall Harvest Collection Spiced Apple CiderCALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.5a6040ff-1779-3215-e063-6294a90aaab12026-08-15WarningsExact identifier
application number: M001
Mylanta Fall Harvest Collection Pumpkin SpiceCALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.5a60a221-5b37-806e-e063-6394a90a5ccc2026-08-15WarningsExact identifier
application number: M001
CVS NaturalsCALCIUM CARBONATECVS PHARMACY899f057a-914d-49ca-a9fd-9fc48149782a2026-08-14WarningsExact identifier
application number: M001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83324-133-01833240133011 BOTTLE, DROPPER in 1 CARTON (83324-133-01) / 30 mL in 1 BOTTLE, DROPPER2024-08-21NoNoCurrent