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 2026-12-31
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 2026-12-31 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 1 of 83 · 1,657 matching rows.
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