Home NDC 0536-1303 Infants
Product NDC 0536-1303
11-digit product format 005361303
Labeler code 0536
Product ID 0536-1303_41f5317f-a058-f03c-e063-6394a90a321a
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form SUSPENSION/ DROPS
Route ORAL
Labeler RUGBY LABORATORIES
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-09-01
Substance DIMETHICONE, UNSPECIFIED
Active strength 20 mg/.3mL
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 Infants
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE, UNSPECIFIED 20 mg/.3mL
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 198857 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0536-1303-75 Infants 30 mL in 1 BOTTLE, DROPPER SUSPENSION/ DROPS 30 6 0536-1303-75 Infants 1 in 1 CARTON SUSPENSION/ DROPS 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0536-1303 INFANTS (SIMETHICONE) SUSPENSION/ DROPS [RUGBY LABORATORIES] 5 Current NDC, Legacy NDC, 2 package rows 20241102_c6fa71bc-de48-47f4-80c4-7d92643d2664.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 1 of 13 · 255 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0536-1303-75 00536130375 1 BOTTLE, DROPPER in 1 CARTON (0536-1303-75) / 30 mL in 1 BOTTLE, DROPPER 2020-09-01 0000-00-00 No No Current