Home NDC 68016-811 Premier Value
Product NDC 68016-811
11-digit product format 680160811
Labeler code 68016
Product ID 68016-811_a73731e6-56d7-43a9-8623-dc9859be4f38
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler PHARMACY VALUE ALLIANCE, LLC
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-05-15
Substance DIMETHICONE, UNSPECIFIED
Active strength 125 mg/1
Pharmacologic classes Skin Barrier Activity [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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
Brand name suffix Extra Strength
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE, UNSPECIFIED 125 mg/1
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 314221 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 68016-811-18 Premier ValueExtra Strength 9 in 1 BLISTER PACK TABLET, CHEWABLE 9 6 68016-811-18 Premier ValueExtra Strength 2 in 1 CARTON TABLET, CHEWABLE 2 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68016-811 PREMIER VALUE EXTRA STRENGTH (SIMETHICONE) TABLET, CHEWABLE [PHARMACY VALUE ALLIANCE, LLC] 6 Current NDC, Legacy NDC, 2 package rows 20241030_df2b1b62-5bd2-4d02-86c2-537b965a8d20.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 11 of 13 · 242 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68016-811-18 68016081118 2 BLISTER PACK in 1 CARTON (68016-811-18) / 9 TABLET, CHEWABLE in 1 BLISTER PACK 2 blister pack 2019-05-15 0000-00-00 No No Current