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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINEACETAMINOPHEN; ASPIRIN; CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-02

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-024b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-02bb7c543d1eb4…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-02e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-02cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211695-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2022-02-02a50c72e98297…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
R16CO5Y76EInternal UNII lookup
3G6A5W338EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308297Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e47e2169-4b31-4c23-bb9d-c26aa106ea37Available on FDA.report

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

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 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMAZON BASIC CARE MIGRAINE RELIEFACETAMINOPHEN, ASPIRIN AND CAFFEINEAmazon.com Services LLC113e8e06-16f2-9341-e063-6294a90af3492024-05-15WarningsExact identifier
application applno (ANDA): 211695
application number: ANDA211695
ACETAMINOPHEN ASPIRIN AND CAFFEINEACETAMINOPHEN, ASPIRIN AND CAFFEINEWALMART INC.12942e9e-1385-5914-e063-6294a90aceac2024-03-05WarningsExact identifier
application applno (ANDA): 211695
application number: ANDA211695
ACETAMINOPHEN ASPIRIN AND CAFFEINEACETAMINOPHEN, ASPIRIN AND CAFFEINEAurohealth LLCf5465419-1453-4ccc-a517-1fdff1eb3c052023-12-01WarningsExact identifier
application applno (ANDA): 211695
application number: ANDA211695
ACETAMINOPHEN ASPIRIN AND CAFFEINEACETAMINOPHEN, ASPIRIN AND CAFFEINEBetter Living Brands, LLCf8050cae-8619-f49b-e053-6294a90ad9e62023-08-17WarningsExact identifier
application applno (ANDA): 211695
application number: ANDA211695
ACETAMINOPHEN ASPIRIN AND CAFFEINEACETAMINOPHEN, ASPIRIN AND CAFFEINEAurohealth LLCe47e2169-4b31-4c23-bb9d-c26aa106ea372023-05-11WarningsExact identifier
application applno (ANDA): 211695
application number: ANDA211695
ndc (product): 58602-817

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