Home NDC 55319-558 Pain Reliever
Product NDC 55319-558
11-digit product format 553190558
Labeler code 55319
Product ID 55319-558_f68ae20a-adb2-4577-b077-710f7c88bfbf
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form SUSPENSION
Route ORAL
Labeler Family Dollar (FAMILY WELLNESS)
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-01
Substance ACETAMINOPHEN
Active strength 160 mg/5mL
NDC exclude flag No
Listing certified through 2027-12-31
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 Pain Reliever
Listing expiration 2027-12-31 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 55319-558-08 Pain Reliever 1 in 1 BOX SUSPENSION 1 5 55319-558-08 Pain Reliever 237 mL in 1 BOTTLE, PLASTIC SUSPENSION 237 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55319-558 PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [FAMILY DOLLAR (FAMILY WELLNESS)] 4 Current NDC, 2 package rows 20240327_f8e5fab4-1212-4c60-a160-9b782f76a198.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 59 of 79 · 1,579 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 55319-558-08 55319055808 1 BOTTLE, PLASTIC in 1 BOX (55319-558-08) / 237 mL in 1 BOTTLE, PLASTIC 2023-07-01 No No Current