Home NDC 63868-696 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 Ingredient Strength DIMETHICONE, UNSPECIFIED 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198857 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63868-696-30 Quality Choice Infants Dye Free Gas Relief 30 mL in 1 BOTTLE, DROPPER EMULSION 30 6 63868-696-30 Quality Choice Infants Dye Free Gas Relief 1 in 1 CARTON EMULSION 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63868-696 QUALITY CHOICE INFANTS DYE FREE GAS RELIEF (SIMETHICONE) EMULSION [CHAIN DRUG MARKETING ASSOCIATION] 5 Current NDC, Legacy NDC, 2 package rows 20241220_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 5 of 13 · 242 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63868-696-30 63868069630 1 BOTTLE, DROPPER in 1 CARTON (63868-696-30) / 30 mL in 1 BOTTLE, DROPPER 2018-12-17 0000-00-00 No No Current