Home NDC 41415-709 Publix Infants Dye Free
Product NDC 41415-709
11-digit product format 414150709
Labeler code 41415
Product ID 41415-709_4236e764-4b25-419f-e063-6394a90a63dc
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form EMULSION
Route ORAL
Labeler PUBLIX SUPER MARKETS, INC
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-05-17
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 Publix Infants Dye Free
Brand name suffix 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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 41415-709-01 Publix Infants Dye FreeGas Relief 1 in 1 CARTON EMULSION 1 7 41415-709-01 Publix Infants Dye FreeGas Relief 30 mL in 1 BOTTLE, DROPPER EMULSION 30 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41415-709 PUBLIX INFANTS DYE FREE GAS RELIEF (SIMETHICONE) EMULSION [PUBLIX SUPER MARKETS, INC] 6 Current NDC, Legacy NDC, 2 package rows 20241030_2fe74800-a1f6-4774-9976-d6767ba34b49.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 1 of 13 · 255 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 41415-709-01 41415070901 1 BOTTLE, DROPPER in 1 CARTON (41415-709-01) / 30 mL in 1 BOTTLE, DROPPER 2019-05-17 0000-00-00 No No Current