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 38 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TYLENOL Extra Strength ACETAMINOPHEN Kenvue Brands LLC ab02080a-c903-4e4a-a9f3-2b8197ed2f2b 2025-09-17 Warnings Exact identifier application number: M013 Childrens TYLENOL ACETAMINOPHEN Kenvue Brands LLC 79669930-f744-4bb1-8325-b75951489b64 2025-09-17 Warnings Exact identifier application number: M013 Pain Reliever PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL L.N.K. International, Inc. ff199db8-c7ea-4b6e-ad8b-3ceeca883d92 2025-09-15 Warnings Exact identifier application number: M013 Acetaminophen PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL FOODHOLD U.S.A., LLC fdd7ce80-d6be-41b9-affd-d024cf306b50 2025-09-12 Warnings Exact identifier application number: M013 Extra Strength Pain Reliever ACETAMINOPHEN INGLES MARKETS, INC. 3e89240b-0e27-fde4-e063-6394a90a779f 2025-09-11 Warnings Exact identifier application number: M013 Aspirin 81 mg Low Dose ASPIRIN HEB 926fe7b6-9607-469f-912f-4019891067a9 2025-09-10 Warnings Exact identifier application number: M013 Bayer Genuine Aspirin ASPIRIN Unifirst First Aid Corporation 356e4ff4-a7f1-4a50-9b86-2555e232b300 2025-09-09 Warnings Exact identifier application number: M013 Medique at Home Aspirin ASPIRIN Unifirst First Aid Corporation b5a469c1-9ab4-5bd7-e053-2995a90a86d1 2025-09-09 Warnings Exact identifier application number: M013 Medique Products Aspirin ASPIRIN Unifirst First Aid Corporation 9b28fed0-a993-ca72-e053-2995a90ac7fd 2025-09-09 Warnings Exact identifier application number: M013 Unishield Aspirin ASPIRIN Unishield ba106b20-32ac-df90-e053-2995a90adaef 2025-09-09 Warnings Exact identifier application number: M013 Medi First Pain Ache ASPIRIN,CAFFEINE Unifirst First Aid Corporation e82d02d5-3e44-a8f8-e053-2a95a90a2688 2025-09-09 Warnings Exact identifier application number: M013 Medique at Home Back Pain Relief MAGNESIUM SALICYLATE Unifirst First Aid Corporation e56c4aef-fa0b-74db-e053-2a95a90a9745 2025-09-09 Warnings Exact identifier application number: M013 Travel Savvy Aspirin ASPIRIN Bellegrove Medical Supply, Inc. bae80044-ad7f-3bf5-e053-2995a90a42f9 2025-09-09 Warnings Exact identifier application number: M013 McKesson Aspirin ASPIRIN McKesson Medical-Surgical dabd741e-e11c-52c1-e053-2a95a90a91d5 2025-09-09 Warnings Exact identifier application number: M013 Travel Savvy Non-Aspirin ACETAMINOPHEN 325MG Bellegrove Medical Supply, Inc. 6ab08633-5d5a-42b2-e053-2991aa0ab41a 2025-09-09 Warnings Exact identifier application number: M013 Direct Safety Aspirin Free ACETAMINOPHEN Conney Safety Products, LLC 1c7369ea-46b6-407c-aa4b-048eb72ff03f 2025-09-09 Warnings Exact identifier application number: M013 Direct Safety Extra Strength Aspirin Free ACETAMINOPHEN Conney Safety Products, LLC a524c36a-38f3-4266-8f45-589e19400328 2025-09-09 Warnings Exact identifier application number: M013 Direct Safety Aspirin ASPIRIN Direct Safety ba9ba697-d3df-49d7-e053-2a95a90af406 2025-09-09 Warnings Exact identifier application number: M013 McKesson Acetaminophen 325 ACETAMINOPHEN McKesson Medical-Surgical, Inc. bc2daba5-ce8b-bbda-e053-2a95a90a6f33 2025-09-09 Warnings Exact identifier application number: M013 Uline Acetaminophen Extra Strength ACETAMINOPHEN Uline 90167594-0a49-2492-e053-2a95a90a1401 2025-09-09 Warnings Exact identifier application number: M013
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