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 61 of 79 · 1,570 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Pain Relief Extra Strength ACETAMINOPHEN Chain Drug Marketing Association 5de40821-3218-4320-bf11-9493bf01d489 2024-10-11 Warnings Exact identifier application number: M013 Pain Relief PM Extra Strength ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE Chain Drug Marketing Association 475becec-1a56-4cfa-a0c5-562f8772adfb 2024-10-11 Warnings Exact identifier application number: M013 Topcare Pain Relief ACETAMINOPHEN Topco Associates LLC 6036c15b-1168-4103-9471-6a74a2140e53 2024-10-10 Warnings Exact identifier application number: M013 Childrens Acetaminophen ACETAMINOPHEN PAI Holdings, LLC dba PAI Pharma 46d9d8cd-e3db-492c-9386-7e8255beff64 2024-10-08 Warnings Exact identifier application number: M013 dg health aspirin ASPIRIN Dolgencorp, LLC 0ab34dc7-0110-4fc3-ae53-234e7d7bca3c 2024-10-07 Warnings Exact identifier application number: M013 ValuMeds Pain Relief PM Pain Reliever and Nighttime Sleep Aid Acetaminophen, Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE Cabinet Health P.B.C. 19ba1fb6-22ea-488e-9e52-94c14ceb80d1 2024-10-07 Warnings Exact identifier application number: M013 foster and thrive aspirin ASPIRIN Strategic Sourcing Services LLC 4d66a8a8-a1c1-4430-8845-21ae67700c39 2024-10-07 Warnings Exact identifier application number: M013 leader aspirin ASPIRIN Cardinal Health 110, LLC. dba Leader ca603b12-e0f7-4d79-8e0d-4651a788ba9b 2024-10-07 Warnings Exact identifier application number: M013 foster and thrive aspirin ASPIRIN McKesson Medical-Surgical, Inc. e9342478-93d6-45de-948f-f4162ee675b2 2024-10-07 Warnings Exact identifier application number: M013 Maximum Strength Backache Relief MAGNESIUM SALICYLATE JHK DBA American Safety & First Aid f8cbcd4e-cfad-4592-8774-52e681494c45 2024-10-07 Warnings Exact identifier application number: M013 Alka-Seltzer Original Flavor ALKA-SELTZER ORIGINAL FLAVOR Navajo Manufacturing Company Inc. f70875ab-241c-4876-e053-6294a90a8092 2024-10-03 Warnings Exact identifier application number: M013 Tylenol Extra Strength ACETAMINOPHEN Navajo Manufacturing Company Inc. 86b6ac01-3866-4cd8-a1be-9babb6ff311b 2024-10-02 Warnings Exact identifier application number: M013 childrens pain relief ACETAMINOPHEN Publix Super Markets Inc de7dd4dc-c5df-4cac-a83a-b21a7637f339 2024-10-02 Warnings Exact identifier application number: M013 Good Neighbor Pharmacy childrens pain and fever ACETAMINOPHEN Amerisource Bergen 6ba153b7-9dc9-4e42-9176-13b3922268bd 2024-10-02 Warnings Exact identifier application number: M013 equaline acetaminophen ACETAMINOPHEN United Natural Foods, Inc. dba UNFI d418c676-03c3-4031-bbf4-8bf908d10e4c 2024-10-02 Warnings Exact identifier application number: M013 childrens fever reducer and pain reliever ACETAMINOPHEN Rite Aid Corporation f6e51c4b-2941-4862-8262-bd9716324841 2024-10-02 Warnings Exact identifier application number: M013 Extra Strength PM Pain Medicine ACETAMINOPHEN, DIPHENHYDRAMINE HCL Amerisource Bergen 23fbda2b-885b-ce00-e063-6294a90a586e 2024-10-01 Warnings Exact identifier application number: M013 LOW DOSE ASPIRIN ASPIRIN Proficient Rx LP e839bff7-779a-446d-8486-c0e0a1b6d665 2024-10-01 Warnings Exact identifier application number: M013 Aspirin Low Dose Chewable Orange ASPIRIN Proficient Rx LP 9e08b91c-b067-4ccd-ae0d-01f48f992f20 2024-10-01 Warnings Exact identifier application number: M013 Good Sense Pain Relief ACETAMINOPHEN A-S Medication Solutions d9bebb47-6ff4-4ddc-b48f-18f942373484 2024-09-30 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