Home NDC 82804-152 Simethicone 125 mg
Product NDC 82804-152
11-digit product format 828040152
Labeler code 82804
Product ID 82804-152_078ef54e-96b2-4e2f-bebc-9b9bcda1f90a
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Proficient Rx LP
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-04-25
Substance DIMETHICONE
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 Simethicone 125 mg
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82804-152-09 Simethicone 125 mg 9 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 9 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82804-152 SIMETHICONE 125 MG (SIMETHICONE) TABLET, CHEWABLE [PROFICIENT RX LP] 1 Current NDC, 1 package rows 20241006_078ef54e-96b2-4e2f-bebc-9b9bcda1f90a.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 5 of 13 · 255 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 82804-152-09 82804015209 9 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-152-09) 2024-09-25 No No Current