Home NDC 83393-390 Syncol Max
Product NDC 83393-390
11-digit product format 833930390
Labeler code 83393
Product ID 83393-390_6582e754-2d02-4066-a5a5-6c8cfac231e3
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Caffeine, Pyrilamine maleate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Laboratorios Sanfer, S.A. de C.V.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-02-09
Substance ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE
Active strength 500; 60; 15 mg/1; 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 Additional Listing Data#
Finished product Yes
Brand name base Syncol Max
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 CAFFEINE 60 mg/1 PYRILAMINE MALEATE 15 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 3G6A5W338E Internal UNII lookup R35D29L3ZA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1597298 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 83393-390-02 Syncol Max 1 in 1 CARTON TABLET, FILM COATED 1 4 83393-390-02 Syncol Max 12 in 1 BLISTER PACK TABLET, FILM COATED 12 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83393-390 SYNCOL MAX (ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE) TABLET, FILM COATED [LABORATORIOS SANFER, S.A. DE C.V.] 3 Current NDC, 2 package rows 20250429_c844d5c4-3e4b-4169-904e-eb5c3334bc4e.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 84 · 1,679 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 83393-390-02 83393039002 1 BLISTER PACK in 1 CARTON (83393-390-02) / 12 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2024-02-09 No No Current