Home NDC 72090-007-03 GenCare Headache Relief
Product NDC 72090-007
Requested package NDC 72090-007-03
11-digit product format 720900007
Labeler code 72090
Product ID 72090-007_a8bfc70a-d470-4283-9e12-effad5fc9947
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, Aspirin, Caffeine
Dosage form TABLET
Route ORAL
Labeler Pioneer Life Sciences, LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-10-02
Substance CAFFEINE; ACETAMINOPHEN; ASPIRIN
Active strength 65; 250; 250 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 GenCare Headache Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAFFEINE 65 mg/1 ACETAMINOPHEN 250 mg/1 ASPIRIN 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3G6A5W338E Internal UNII lookup 362O9ITL9D Internal UNII lookup R16CO5Y76E 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72090-007-02 GenCare Headache Relief 300 in 1 BOTTLE TABLET 300 8 72090-007-03 GenCare Headache Relief 200 in 1 BOTTLE TABLET 200 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72090-007 GENCARE HEADACHE RELIEF (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [PIONEER LIFE SCIENCES, LLC] 7 Current NDC, Legacy NDC, 1 package rows 20241004_ac8c4bdf-30c9-2b09-e053-2a95a90a9b67.zip 72090-007 GENCARE HEADACHE RELIEF (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [PIONEER LIFE SCIENCES, LLC] 1 Current NDC, Legacy NDC, 1 package rows 20241004_667f6f1b-5179-481c-a131-940c7937aada.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 Units Marketing start Sample Exclude flag Status 72090-007-03 72090000703 200 TABLET in 1 BOTTLE (72090-007-03) 200 tablet 2024-10-02 No No Current