Home NDC 53345-036 Simethicone
Product NDC 53345-036
11-digit product format 533450036
Labeler code 53345
Product ID 53345-036_27c818a0-ee73-b3e3-e063-6394a90a83e9
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-07-25
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
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 252294 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 53345-036-01 Simethicone 25000 in 1 BAG CAPSULE, LIQUID FILLED 25000 2 53345-036-01 Simethicone 1 in 1 BOX CAPSULE, LIQUID FILLED 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53345-036 SIMETHICONE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD] 2 Current NDC, Legacy NDC, 2 package rows 20241127_346df37d-b0fc-4fa5-8c19-492fed58c239.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 Units Marketing start Marketing end Sample Exclude flag Status 53345-036-01 53345003601 1 BAG in 1 BOX (53345-036-01) / 25000 CAPSULE, LIQUID FILLED in 1 BAG 1 bag 2016-07-25 0000-00-00 No No Current