Home NDC 68016-670 premier value infants gas relief
Product NDC 68016-670
11-digit product format 680160670
Labeler code 68016
Product ID 68016-670_2b8605c2-dcb3-48e0-ac8e-9c583d0a758d
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form EMULSION
Route ORAL
Labeler Chain Drug Consortium
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-01-09
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 premier value infants 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 68016-670-00 premier value infants gas relief 1 in 1 CARTON EMULSION 1 8 68016-670-00 premier value infants gas relief 30 mL in 1 BOTTLE, DROPPER EMULSION 30 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68016-670 PREMIER VALUE INFANTS GAS RELIEF (SIMETHICONE) EMULSION [CHAIN DRUG CONSORTIUM] 8 Current NDC, Legacy NDC, 2 package rows 20241030_7b887e53-a70a-4f33-9472-e1175b24400a.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 68016-670-00 68016067000 1 BOTTLE, DROPPER in 1 CARTON (68016-670-00) / 30 mL in 1 BOTTLE, DROPPER 2015-01-09 0000-00-00 No No Current