FDA.reportPublic FDA data

Quality Choice Infants Dye Free Gas Relief

Product NDC
63868-696
11-digit product format
638680696
Labeler code
63868
Product ID
63868-696_451d7550-2e7d-051e-e063-6394a90aea9e
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
EMULSION
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-12-17
Substance
DIMETHICONE, UNSPECIFIED
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 Dye Free Gas Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE, UNSPECIFIED20 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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198857Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6b8a1eaa-6f8c-4ab6-81e0-9d64f6f1b5e4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-696-30Quality Choice Infants Dye Free Gas Relief30 mL in 1 BOTTLE, DROPPEREMULSION306
63868-696-30Quality Choice Infants Dye Free Gas Relief1 in 1 CARTONEMULSION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-696-30ML - Milliliter63868-696535a7422-10b9-4db9-be53-508ddc6eed3b12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-696QUALITY CHOICE INFANTS DYE FREE GAS RELIEF (SIMETHICONE) EMULSION [CHAIN DRUG MARKETING ASSOCIATION]5Current NDC, Legacy NDC, 2 package rows20241220_6b8a1eaa-6f8c-4ab6-81e0-9d64f6f1b5e4.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 13 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti-GasSIMETHICONEAllegiant Health7731bd63-667e-4fed-b446-92a4a83b66d62020-11-03WarningsExact identifier
application number: M002
Anti-GasSIMETHICONEMarc Glassman, Inc.e99f2041-2543-4331-9f54-9eea179f94d22020-10-06WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSN6b8a1eaa-6f8c-4ab6-81e0-9d64f6f1b5e46
198857simethicone 66.7 MG/ML Oral SuspensionSCD6b8a1eaa-6f8c-4ab6-81e0-9d64f6f1b5e46
198857simethicone 20 MG per 0.3 ML Oral SuspensionSY6b8a1eaa-6f8c-4ab6-81e0-9d64f6f1b5e46
198857simethicone 40 MG per 0.6 ML Oral SuspensionSY6b8a1eaa-6f8c-4ab6-81e0-9d64f6f1b5e46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-696-30638680696301 BOTTLE, DROPPER in 1 CARTON (63868-696-30) / 30 mL in 1 BOTTLE, DROPPER2018-12-170000-00-00NoNoCurrent