FDA.reportPublic FDA data

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
IngredientStrength
ACETAMINOPHEN500 mg/1
CAFFEINE60 mg/1
PYRILAMINE MALEATE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 3G6A5W338E, R35D29L3ZA
Rxcui1597298

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83393-390-02Syncol Max1 in 1 CARTONTABLET, FILM COATED14
83393-390-02Syncol Max12 in 1 BLISTER PACKTABLET, FILM COATED124

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83393-390SYNCOL MAX (ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE) TABLET, FILM COATED [LABORATORIOS SANFER, S.A. DE C.V.]3Current NDC, 2 package rows20250429_c844d5c4-3e4b-4169-904e-eb5c3334bc4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletPSNc844d5c4-3e4b-4169-904e-eb5c3334bc4e4
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletSCDc844d5c4-3e4b-4169-904e-eb5c3334bc4e4
1597298APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral TabletSYc844d5c4-3e4b-4169-904e-eb5c3334bc4e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83393-390-02833930390021 BLISTER PACK in 1 CARTON (83393-390-02) / 12 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2024-02-09NoNoHistorical