Home NDC 49580-0685 Dye Free Pain Reliever
Product NDC 49580-0685
11-digit product format 495800685
Labeler code 49580
Product ID 49580-0685_f446b9fa-069b-48e1-8ae4-ec5ad945f67c
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form SUSPENSION
Route ORAL
Labeler P & L Development, LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-02-28
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 Dye Free Pain Reliever
Brand name suffix Childrens
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 49580-0685-4 Dye Free Pain RelieverChildrens 1 in 1 BOX SUSPENSION 1 4 49580-0685-4 Dye Free Pain RelieverChildrens 118 mL in 1 BOTTLE, PLASTIC SUSPENSION 118 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49580-0685 DYE FREE PAIN RELIEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [P & L DEVELOPMENT, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20240417_45ddcaad-d416-4d7c-a84a-43548d5c5d3b.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 Marketing start Marketing end Sample Exclude flag Status 49580-0685-4 49580068504 1 BOTTLE, PLASTIC in 1 BOX (49580-0685-4) / 118 mL in 1 BOTTLE, PLASTIC 2018-02-28 0000-00-00 No No Current