Home NDC 55758-509 Dolex Forte
Product NDC 55758-509
11-digit product format 557580509
Labeler code 55758
Product ID 55758-509_462857bf-e00b-287d-e063-6294a90aa93b
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Aspirin, Caffeine
Dosage form TABLET
Route ORAL
Labeler Pharmadel LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-08-12
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 openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 84 · 1,678 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Dolex Forte
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 55758-509-02 Dolex Forte 2 in 1 PACKET TABLET 2 2 55758-509-24 Dolex Forte 1 in 1 CARTON TABLET 1 2 55758-509-24 Dolex Forte 24 in 1 BOTTLE TABLET 24 2 55758-509-50 Dolex Forte 25 in 1 BOX TABLET 25 2
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55758-509-02 55758050902 2 in 1 PACKET Historical 55758-509-24 55758050924 1 BOTTLE in 1 CARTON (55758-509-24) / 24 TABLET in 1 BOTTLE 1 bottle 2025-08-12 No No Current 55758-509-50 55758050950 25 PACKET in 1 BOX (55758-509-50) / 2 TABLET in 1 PACKET (55758-509-02) 25 packet 2025-08-12 No No Current