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

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 Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui198857

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

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