Home NDC 55319-511 Headache Relief
Product NDC 55319-511
11-digit product format 553190511
Labeler code 55319
Product ID 55319-511_7d9f0bdd-d235-4bb1-8f5c-82f462f78e9d
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Aspirin, Caffeine
Dosage form TABLET
Route ORAL
Labeler Family Dollar (FAMILY WELLNESS)
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-11-27
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 Headache Relief
Brand name suffix Extra Strength
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 55319-511-10 Headache ReliefExtra Strength 100 in 1 BOTTLE, PLASTIC TABLET 100 3 55319-511-10 Headache ReliefExtra Strength 1 in 1 BOX TABLET 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55319-511 HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [FAMILY DOLLAR (FAMILY WELLNESS)] 3 Current NDC, Legacy NDC, 2 package rows 20240328_650cb15e-c448-4df3-b0f8-4398be05d841.zip
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 Marketing end Sample Exclude flag Status 55319-511-10 55319051110 1 BOTTLE, PLASTIC in 1 BOX (55319-511-10) / 100 TABLET in 1 BOTTLE, PLASTIC 2020-11-27 0000-00-00 No No Current