Home NDC 0363-9945 Simethicone
Product NDC 0363-9945
11-digit product format 003639945
Labeler code 0363
Product ID 0363-9945_27788635-ce7b-f0bb-e063-6394a90abe4b
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler WALGREEN CO.
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-04-15
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
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 0363-9945-02 Simethicone 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 3 0363-9945-02 Simethicone 12 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 12 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-9945 SIMETHICONE CAPSULE, LIQUID FILLED [WALGREEN CO.] 3 Current NDC, Legacy NDC, 2 package rows 20241123_4d523979-e3ae-47e8-9092-00fdffc8bb0b.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 0363-9945-02 00363994502 1 BLISTER PACK in 1 CARTON (0363-9945-02) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 1 blister pack 2019-04-15 0000-00-00 No No Current