Home NDC 0536-1426 rugby infants acetaminophen
Product NDC 0536-1426
11-digit product format 005361426
Labeler code 0536
Product ID 0536-1426_afed6c7e-d3b5-4ec8-954e-2780a7b04e3a
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form SUSPENSION
Route ORAL
Labeler Rugby Laboratories
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-03-25
Substance ACETAMINOPHEN
Active strength 160 mg/5mL
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 rugby infants acetaminophen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 160 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 307668 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 0536-1426-77 rugby infants acetaminophen 1 in 1 CARTON SUSPENSION 1 2 0536-1426-77 rugby infants acetaminophen 59 mL in 1 BOTTLE SUSPENSION 59 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0536-1426 RUGBY INFANTS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [RUGBY LABORATORIES] 2 Current NDC, 2 package rows 20240413_8aa9ac68-ca61-4163-a876-52034138c1ea.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 83 · 1,657 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0536-1426-77 00536142677 1 BOTTLE in 1 CARTON (0536-1426-77) / 59 mL in 1 BOTTLE 1 bottle 2024-03-25 No No Current