Home NDC 0363-0118 Walgreens
Product NDC 0363-0118
11-digit product format 003630118
Labeler code 0363
Product ID 0363-0118_44698c74-8eef-961f-e063-6394a90ab6a1
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler WALGREENS CO.
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-05-15
Substance DIMETHICONE, UNSPECIFIED
Active strength 125 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 Walgreens
Brand name suffix Extra Strength
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE, UNSPECIFIED 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0363-0118-09 WalgreensExtra Strength 9 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 9 8 0363-0118-18 WalgreensExtra Strength 9 in 1 BLISTER PACK TABLET, CHEWABLE 9 8 0363-0118-18 WalgreensExtra Strength 2 in 1 CARTON TABLET, CHEWABLE 2 8 0363-0118-48 WalgreensExtra Strength 4 in 1 CARTON TABLET, CHEWABLE 4 8 0363-0118-48 WalgreensExtra Strength 12 in 1 BLISTER PACK TABLET, CHEWABLE 12 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-0118 WALGREENS EXTRA STRENGTH (SIMETHICONE) TABLET, CHEWABLE [WALGREENS CO.] 7 Current NDC, Legacy NDC, 5 package rows 20241110_dbd2ed5b-14b1-4bdf-bd0a-84579ca3d815.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 0363-0118-09 00363011809 9 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (0363-0118-09) 2023-05-22 No No Current 0363-0118-18 00363011818 2 BLISTER PACK in 1 CARTON (0363-0118-18) / 9 TABLET, CHEWABLE in 1 BLISTER PACK 2 blister pack 2019-05-15 0000-00-00 No No Current 0363-0118-48 00363011848 4 BLISTER PACK in 1 CARTON (0363-0118-48) / 12 TABLET, CHEWABLE in 1 BLISTER PACK 4 blister pack 2019-05-15 0000-00-00 No No Current