FDA.reportPublic FDA data

ACETAMINOPHEN ASPIRIN AND CAFFEINE

Product NDC
58602-817
11-digit product format
586020817
Labeler code
58602
Product ID
58602-817_663a4a3d-c77c-44a8-a082-ee65baf3c6af
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, aspirin and caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA211695
Marketing category
ANDA
Marketing start
2022-02-02
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

Additional Listing Data#

Finished product
Yes
Brand name base
ACETAMINOPHEN ASPIRIN AND CAFFEINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN250 mg/1
ASPIRIN250 mg/1
CAFFEINE65 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, R16CO5Y76E, 3G6A5W338E
Rxcui308297

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
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct 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
58602-817-02ACETAMINOPHEN ASPIRIN AND CAFFEINE1 in 1 CARTONTABLET, FILM COATED13
58602-817-02ACETAMINOPHEN ASPIRIN AND CAFFEINE8 in 1 BOTTLETABLET, FILM COATED83
58602-817-03ACETAMINOPHEN ASPIRIN AND CAFFEINE10 in 1 BOTTLETABLET, FILM COATED103
58602-817-03ACETAMINOPHEN ASPIRIN AND CAFFEINE1 in 1 CARTONTABLET, FILM COATED13
58602-817-07ACETAMINOPHEN ASPIRIN AND CAFFEINE24 in 1 BOTTLETABLET, FILM COATED243
58602-817-07ACETAMINOPHEN ASPIRIN AND CAFFEINE1 in 1 CARTONTABLET, FILM COATED13
58602-817-09ACETAMINOPHEN ASPIRIN AND CAFFEINE1 in 1 CARTONTABLET, FILM COATED13
58602-817-09ACETAMINOPHEN ASPIRIN AND CAFFEINE30 in 1 BOTTLETABLET, FILM COATED303
58602-817-14ACETAMINOPHEN ASPIRIN AND CAFFEINE1 in 1 CARTONTABLET, FILM COATED13
58602-817-14ACETAMINOPHEN ASPIRIN AND CAFFEINE50 in 1 BOTTLETABLET, FILM COATED503
58602-817-21ACETAMINOPHEN ASPIRIN AND CAFFEINE1 in 1 CARTONTABLET, FILM COATED13
58602-817-21ACETAMINOPHEN ASPIRIN AND CAFFEINE100 in 1 BOTTLETABLET, FILM COATED1003
58602-817-34ACETAMINOPHEN ASPIRIN AND CAFFEINE200 in 1 BOTTLETABLET, FILM COATED2003
58602-817-36ACETAMINOPHEN ASPIRIN AND CAFFEINE250 in 1 BOTTLETABLET, FILM COATED2503
58602-817-38ACETAMINOPHEN ASPIRIN AND CAFFEINE300 in 1 BOTTLETABLET, FILM COATED3003
58602-817-90ACETAMINOPHEN ASPIRIN AND CAFFEINE1 in 1 CARTONTABLET, FILM COATED13
58602-817-90ACETAMINOPHEN ASPIRIN AND CAFFEINE125 in 1 BOTTLETABLET, FILM COATED1253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-817ACETAMINOPHEN ASPIRIN AND CAFFEINE (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [AUROHEALTH LLC]3Current NDC, Legacy NDC, 17 package rows20230517_e47e2169-4b31-4c23-bb9d-c26aa106ea37.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSNe47e2169-4b31-4c23-bb9d-c26aa106ea373
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCDe47e2169-4b31-4c23-bb9d-c26aa106ea373
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSYe47e2169-4b31-4c23-bb9d-c26aa106ea373

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-817-02586020817021 BOTTLE in 1 CARTON (58602-817-02) / 8 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-02-020000-00-00NoNoCurrent
58602-817-03586020817031 BOTTLE in 1 CARTON (58602-817-03) / 10 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-02-020000-00-00NoNoCurrent
58602-817-07586020817071 BOTTLE in 1 CARTON (58602-817-07) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-02-020000-00-00NoNoCurrent
58602-817-09586020817091 BOTTLE in 1 CARTON (58602-817-09) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-02-020000-00-00NoNoCurrent
58602-817-14586020817141 BOTTLE in 1 CARTON (58602-817-14) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-02-020000-00-00NoNoCurrent
58602-817-21586020817211 BOTTLE in 1 CARTON (58602-817-21) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-02-020000-00-00NoNoCurrent
58602-817-3458602081734200 TABLET, FILM COATED in 1 BOTTLE (58602-817-34) 2022-02-020000-00-00NoNoCurrent
58602-817-3658602081736250 TABLET, FILM COATED in 1 BOTTLE (58602-817-36) 2022-02-020000-00-00NoNoCurrent
58602-817-3858602081738300 TABLET, FILM COATED in 1 BOTTLE (58602-817-38) 2022-02-020000-00-00NoNoCurrent
58602-817-90586020817901 BOTTLE in 1 CARTON (58602-817-90) / 125 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-02-020000-00-00NoNoCurrent