Home NDC 0536-1321 Rugby Childrens Acetaminophen
Product NDC 0536-1321
11-digit product format 005361321
Labeler code 0536
Product ID 0536-1321_d7ac78ac-7c67-4a15-910e-fb6efbde3ff4
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form SUSPENSION
Route ORAL
Labeler Rugby Laboratories
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-10-21
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 Childrens 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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0536-1321-97 Rugby Childrens Acetaminophen 1 in 1 CARTON SUSPENSION 1 2 0536-1321-97 Rugby Childrens Acetaminophen 118 mL in 1 BOTTLE SUSPENSION 118 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0536-1321 RUGBY CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [RUGBY LABORATORIES] 2 Current NDC, Legacy NDC, 2 package rows 20240509_304a9aa2-9198-44ca-8627-d41b84ec6cbf.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 Marketing end Sample Exclude flag Status 0536-1321-97 00536132197 1 BOTTLE in 1 CARTON (0536-1321-97) / 118 mL in 1 BOTTLE 1 bottle 2020-10-21 0000-00-00 No No Current