Home NDC 71610-607 Simethicone
Product NDC 71610-607
11-digit product format 716100607
Labeler code 71610
Product ID 71610-607_57e89b75-97c2-f188-e063-6294a90a6cc6
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2011-03-01
Substance DIMETHICONE
Active strength 80 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 Simethicone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 80 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 314216 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 71610-607-04 Simethicone 4 in 1 BOTTLE TABLET, CHEWABLE 4 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-607 SIMETHICONE TABLET, CHEWABLE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 Current NDC, Legacy NDC, 1 package rows 20250112_da0cc98e-1692-405a-ab81-420d6f9df6de.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 Marketing start Marketing end Sample Exclude flag Status 71610-607-02 71610060702 2 TABLET, CHEWABLE in 1 BOTTLE (71610-607-02) 2026-07-28 No No Current 71610-607-04 71610060704 4 TABLET, CHEWABLE in 1 BOTTLE (71610-607-04) 2021-10-25 0000-00-00 No No Current