Home NDC 85786-105 Dr Simi Extra Strength Acetaminophen 250 mg, Aspirin 250 mg, and Caffeine 65 mg
Product NDC 85786-105
11-digit product format 857860105
Labeler code 85786
Product ID 85786-105_48ea0a2c-511c-4805-e063-6394a90a1225
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen 250 mg, Aspirin 250 mg, and Caffeine 65 mg
Dosage form TABLET, COATED
Route ORAL
Labeler Farmacias De Similares TX LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-01-01
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 Dr Simi Extra Strength Acetaminophen 250 mg, Aspirin 250 mg, and Caffeine 65 mg
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 85786-105-90 Dr Simi Extra Strength Acetaminophen 250 mg, Aspirin 250 mg, and Caffeine 65 mg 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 1
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 85786-105-90 85786010590 100 TABLET, COATED in 1 BOTTLE, PLASTIC (85786-105-90) 2026-01-01 No No Current