Home NDC 80513-362 Extra Strength Headache Relief
Product NDC 80513-362
11-digit product format 805130362
Labeler code 80513
Product ID 80513-362_3f0f7803-0747-baa9-e063-6394a90aac25
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Aspirin, and Caffeine
Dosage form TABLET
Route ORAL
Labeler Advanced Rx LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-07-01
Substance ACETAMINOPHEN; ASPIRIN; CAFFEINE
Active strength 250; 250; 65 mg/1; mg/1; mg/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
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 Extra Strength Headache Relief
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 250 mg/1 ASPIRIN 250 mg/1 CAFFEINE 65 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 3G6A5W338E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308297 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 80513-362-15 Extra Strength Headache Relief 150 in 1 BOTTLE TABLET 150 1
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 58 of 79 · 1,570 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Acetaminophen ACETAMINOPHEN Kroger Company 5bfd9841-c781-43be-b823-d334893ae6ed 2024-10-24 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN H E B add6952e-9dd5-487c-93e6-337e9d6a4872 2024-10-24 Warnings Exact identifier application number: M013 Dye Free Pain Reliever Childrens ACETAMINOPHEN Safeway, Inc. 7d55cb42-295f-473a-941d-71825b44a3c0 2024-10-24 Warnings Exact identifier application number: M013 rapid release pain relief ACETAMINOPHEN Publix Super Markets Inc d0b34133-d69d-47db-bf51-be942769c612 2024-10-24 Warnings Exact identifier application number: M013 basic care acetaminophen ACETAMINOPHEN Amazon.com Services LLC 00146b91-008d-4b16-95b0-6077f98821be 2024-10-24 Warnings Exact identifier application number: M013 equate pain reliever ACETAMINOPHEN WALMART INC. 9a20273e-a4d1-4c38-9efb-e6347f8dc14e 2024-10-24 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN MARC GLASSMAN, INC. e221905b-a795-c067-e053-2a95a90a02e7 2024-10-23 Warnings Exact identifier application number: M013 Pain Relief PM Extra Strength ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE MARC GLASSMAN, INC. e221bbce-83de-0f03-e053-2995a90abca5 2024-10-23 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN MARC GLASSMAN, INC. e231c2f6-927c-1ab0-e053-2995a90a6121 2024-10-23 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN MARC GLASSMAN, INC. e23703bb-6087-7985-e053-2995a90aa5ec 2024-10-23 Warnings Exact identifier application number: M013 Pain Relief PM Extra Strength ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE MARC GLASSMAN, INC. e237550d-711d-5d87-e053-2995a90affce 2024-10-23 Warnings Exact identifier application number: M013 Aspirin ASPIRIN HARRIS TEETER a6f15f71-1327-4b71-b9d6-e3e9f0243801 2024-10-22 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN HARRIS TEETER 43308b23-7d4f-4e4f-a497-af71920d86aa 2024-10-22 Warnings Exact identifier application number: M013 Pain Relief Regular Strength ACETAMINOPHEN MARC GLASSMAN, INC. e21e821c-9694-5db0-e053-2995a90ad034 2024-10-22 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN MARC GLASSMAN, INC. e21e90e8-b9f1-1133-e053-2995a90a664b 2024-10-22 Warnings Exact identifier application number: M013 aspirin ASPIRIN Publix Super Markets Inc c51dae48-aa49-4926-b04a-0da264e08dfa 2024-10-22 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN KROGER COMPANY b96a2280-ec4f-7c61-e053-2995a90a18bb 2024-10-22 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN HEB f17a18b0-a7c2-4c64-868c-460cf34e1f7d 2024-10-21 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN HEB 0863aeaa-15ec-4c67-ba79-4dad54555bd2 2024-10-21 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN American Health Packaging 3c0175a0-175b-48b8-9192-3f869690c0f2 2024-10-21 Warnings Exact identifier application number: M013
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80513-362-15 80513036215 150 TABLET in 1 BOTTLE (80513-362-15) 150 tablet 2025-07-01 No No Current