Home NDC 82804-043 Simethicone 80 mg
Product NDC 82804-043
11-digit product format 828040043
Labeler code 82804
Product ID 82804-043_c27c3d6a-64ca-47d4-bba6-a0c5288e755b
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 2018-04-24
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 80 mg
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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82804-043-30 Simethicone 80 mg 30 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 30 2 82804-043-60 Simethicone 80 mg 60 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 60 2 82804-043-90 Simethicone 80 mg 90 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82804-043 SIMETHICONE 80 MG (SIMETHICONE) TABLET, CHEWABLE [PROFICIENT RX LP] 2 Current NDC, 3 package rows 20241024_a5e523b3-475e-4d28-a89c-c4325c59c939.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 82804-043-30 82804004330 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-043-30) 2023-11-16 No No Current 82804-043-60 82804004360 60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-043-60) 2023-11-16 No No Current 82804-043-90 82804004390 90 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-043-90) 2023-11-16 No No Current