Home NDC 17714-076 Simethicone
Product NDC 17714-076
11-digit product format 177140076
Labeler code 17714
Product ID 17714-076_2a3255ec-164d-c398-e063-6394a90a5a02
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form GEL
Route ORAL
Labeler Advance Pharmaceutical Inc.
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-11-11
Substance DIMETHICONE
Active strength 180 mg/1
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 Simethicone
Brand name suffix Certified Plus
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 180 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 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 17714-076-18 SimethiconeCertified Plus 180 in 1 BOTTLE GEL 180 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17714-076 SIMETHICONE CERTIFIED PLUS (SIMETHICONE) GEL [ADVANCE PHARMACEUTICAL INC.] 2 Current NDC, Legacy NDC, 1 package rows 20241228_d087743f-b82f-2a5c-e053-2995a90abb20.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 17714-076-18 17714007618 180 GEL in 1 BOTTLE (17714-076-18) 180 gel 2021-11-11 0000-00-00 No No Current