Home NDC 55319-562 Pain Reliever PM
Product NDC 55319-562
11-digit product format 553190562
Labeler code 55319
Product ID 55319-562_1dc1bd15-bee3-4602-9687-5b2e1d55c00a
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine HCl
Dosage form TABLET, COATED
Route ORAL
Labeler Family Dollar (FAMILY WELLNESS)
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-01
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 500; 25 mg/1; mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
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 PM
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup TC2D6JAD40 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1092189 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 55319-562-10 Pain Reliever PM 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 7 55319-562-10 Pain Reliever PM 1 in 1 BOX TABLET, COATED 1 7 55319-562-24 Pain Reliever PM 24 in 1 BOTTLE, PLASTIC TABLET, COATED 24 7 55319-562-24 Pain Reliever PM 1 in 1 BOX TABLET, COATED 1 7 55319-562-50 Pain Reliever PM 1 in 1 BOX TABLET, COATED 1 7 55319-562-50 Pain Reliever PM 50 in 1 BOTTLE, PLASTIC TABLET, COATED 50 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55319-562 PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [FAMILY DOLLAR (FAMILY WELLNESS)] 6 Current NDC, 6 package rows 20250410_7a98d4d9-54e2-45c1-a76a-7f1907566e95.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 55319-562-10 55319056210 1 BOTTLE, PLASTIC in 1 BOX (55319-562-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC 2023-07-01 No No Current 55319-562-24 55319056224 1 BOTTLE, PLASTIC in 1 BOX (55319-562-24) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC 2023-07-01 No No Current 55319-562-50 55319056250 1 BOTTLE, PLASTIC in 1 BOX (55319-562-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC 2023-07-01 No No Current