Home NDC 73629-006 Simethicone 250mg
Product NDC 73629-006
11-digit product format 736290006
Labeler code 73629
Product ID 73629-006_2b3b212d-55b4-ca76-e063-6394a90a984e
Type HUMAN OTC DRUG
Nonproprietary name Simethicone 250mg
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler AMZ789 LLC
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-12-01
Substance DIMETHICONE
Active strength 250 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 250mg
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 250 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 412111 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 73629-006-12 Simethicone 250mg 120 in 1 BOTTLE CAPSULE, LIQUID FILLED 120 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73629-006 SIMETHICONE 250MG CAPSULE, LIQUID FILLED [AMZ789 LLC] 2 Current NDC, 1 package rows 20250110_fcc2ef8b-9181-2c59-e053-6394a90adcc1.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 · 242 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 73629-006-12 73629000612 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (73629-006-12) 2022-12-01 No No Current