Home NDC 46122-690-78 Headache Relief
Product NDC 46122-690
Requested package NDC 46122-690-78
11-digit product format 461220690
Labeler code 46122
Product ID 46122-690_4220b358-7b6b-4324-b439-3a1366daeadd
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Aspirin, Caffeine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Amerisource Bergen
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-03-11
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
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 46122-690-78 Headache Relief 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 8 46122-690-78 Headache Relief 1 in 1 CARTON TABLET, FILM COATED 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46122-690 HEADACHE RELIEF (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [AMERISOURCE BERGEN] 7 Current NDC, Legacy NDC, 2 package rows 20250529_566dbd02-5e04-4461-8f5f-9fb58a42a375.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 79 · 1,579 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 46122-690-78 46122069078 1 BOTTLE, PLASTIC in 1 CARTON (46122-690-78) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2021-03-11 0000-00-00 No No Current