Home NDC 69729-795-24 DOLONEURO-TROPAS
Product NDC 69729-795
Requested package NDC 69729-795-24
11-digit product format 697290795
Labeler code 69729
Product ID 69729-795_5ca46bf9-e54d-5d84-e063-6294a90a82a9
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Caffeine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler OPMX LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-01-29
Substance ACETAMINOPHEN; CAFFEINE
Active strength 500; 65 mg/1; mg/1
Pharmacologic classes Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [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 DOLONEURO-TROPAS
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 CAFFEINE 65 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69729-795-24 DOLONEURO-TROPAS 12 in 1 BLISTER PACK TABLET, FILM COATED 12 4 69729-795-24 DOLONEURO-TROPAS 2 in 1 CARTON TABLET, FILM COATED 2 4 69729-795-80 DOLONEURO-TROPAS 20 in 1 CARTON TABLET, FILM COATED 20 1 69729-795-80 DOLONEURO-TROPAS 4 in 1 BLISTER PACK TABLET, FILM COATED 4 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69729-795 DOLONEURO-TROPAS (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [OPMX LLC] 4 Current NDC, 2 package rows 20250417_31bb39f4-3b7e-c983-e063-6294a90abccd.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 69729-795-24 69729079524 2 BLISTER PACK in 1 CARTON (69729-795-24) / 12 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2025-04-01 No No Current