FDA.reportPublic FDA data

Acetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mg

Product NDC
0363-2310
11-digit product format
003632310
Labeler code
0363
Product ID
0363-2310_c4826edc-d2bc-4903-9da6-cf25d064ce86
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mg
Dosage form
TABLET
Route
ORAL
Labeler
WALGREENS CO.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-05
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
2026-12-31
Current FDA listing
Yes

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-2310-242022-04-06C16284748780-1d6a99b39-48ed-a426-e053-dadaa90af4c2Walgreens Menstrual Complete Pain Relief Acetaminophen 500mg, Caffeine 60mg, Pyrilamine Maleate 15mg
0363-2310-242022-01-28C16284748780-1d6a99b39-48ed-a426-e053-dadaa90af4c2Walgreens Menstrual Complete Pain Relief Acetaminophen 500mg, Caffeine 60mg, Pyrilamine Maleate 15mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-2310-24Acetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mg24 in 1 PACKAGETABLET245

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-2310-24EA - Each0363-2310b2e6f9ed-0fe6-4225-b78c-4b1e8634efd112022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-2310ACETAMINOPHEN 500MG CAFFEINE 60MG PYRILAMINE MALEATE 15MG TABLET [WALGREENS CO.]5Current NDC, Legacy NDC, 1 package rows20250106_982faa74-d498-cd1e-e053-2995a90afa1e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletPSN982faa74-d498-cd1e-e053-2995a90afa1e5
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletSCD982faa74-d498-cd1e-e053-2995a90afa1e5
1597298APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral TabletSY982faa74-d498-cd1e-e053-2995a90afa1e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-2310-240036323102424 TABLET in 1 PACKAGE (0363-2310-24) 24 tablet2019-07-050000-00-00NoNoCurrent