Home NDC 82804-163 EXTRA STRENGTH PAIN RELIEVER
Product NDC 82804-163
11-digit product format 828040163
Labeler code 82804
Product ID 82804-163_bf365bfc-35cc-47f9-a50b-ff2b38d7316b
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, ASPIRIN AND CAFFEINE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Proficient Rx LP
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-02-01
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 PAIN RELIEVER
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 82804-163-60 EXTRA STRENGTH PAIN RELIEVER 60 in 1 BOTTLE TABLET, FILM COATED 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82804-163 EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [PROFICIENT RX LP] 1 Current NDC, 1 package rows 20241109_bf365bfc-35cc-47f9-a50b-ff2b38d7316b.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 Sample Exclude flag Status 82804-163-60 82804016360 60 TABLET, FILM COATED in 1 BOTTLE (82804-163-60) 2024-10-31 No No Current