Home NDC 51316-674 PM Headache
Product NDC 51316-674
11-digit product format 513160674
Labeler code 51316
Product ID 51316-674_32785f2c-d8d4-412e-995f-92b3969360c4
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Aspirin, Diphenhydramine citrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-09-11
Substance ACETAMINOPHEN; ASPIRIN; DIPHENHYDRAMINE CITRATE
Active strength 250; 250; 38 mg/1; mg/1; mg/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [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 PM Headache
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 250 mg/1 ASPIRIN 250 mg/1 DIPHENHYDRAMINE CITRATE 38 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51316-674-12 PM Headache 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 2 51316-674-12 PM Headache 1 in 1 CARTON TABLET, FILM COATED 1 2
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 63 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 51316-674-12 51316067412 1 BOTTLE, PLASTIC in 1 CARTON (51316-674-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2025-09-11 No No Current