Home NDC 51316-674-12 PM Headache
Product NDC 51316-674
Requested package NDC 51316-674-12
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
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup R16CO5Y76E Internal UNII lookup 4OD433S209 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1593110 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 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 1 of 77 · 1,530 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