FDA.reportPublic FDA data

Acetaminophen and Ibuprofen

Product NDC
58602-893
11-digit product format
586020893
Labeler code
58602
Product ID
58602-893_4c479545-4af0-49b7-8a62-632a97c5c637
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA218359
Marketing category
ANDA
Marketing start
2024-03-26
Substance
ACETAMINOPHEN; IBUPROFEN
Active strength
250; 125 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
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 43.

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
A218359-001ACETAMINOPHEN AND IBUPROFENACETAMINOPHEN; IBUPROFEN250MG;125MGTABLET / ORAL2024-03-26

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
2026-09-14 22:38:342026-08A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-2684e616aacf4f…
2026-08-18 06:07:402026-07A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-268072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-26a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Acetaminophen and Ibuprofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN250 mg/1
IBUPROFEN125 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
WK2XYI10QMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2387532Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b39fb93f-c140-40ab-8247-9559ef6df50aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-893-01Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-01Acetaminophen and Ibuprofen24 in 1 BOTTLE, PLASTICTABLET, FILM COATED243
58602-893-02Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-02Acetaminophen and Ibuprofen144 in 1 BOTTLETABLET, FILM COATED1443
58602-893-03Acetaminophen and Ibuprofen10 in 1 BOTTLETABLET, FILM COATED103
58602-893-03Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-07Acetaminophen and Ibuprofen24 in 1 BOTTLETABLET, FILM COATED243
58602-893-07Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-11Acetaminophen and Ibuprofen36 in 1 BOTTLETABLET, FILM COATED363
58602-893-11Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-14Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-14Acetaminophen and Ibuprofen50 in 1 BOTTLETABLET, FILM COATED503
58602-893-21Acetaminophen and Ibuprofen100 in 1 BOTTLETABLET, FILM COATED1003
58602-893-21Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-29Acetaminophen and Ibuprofen150 in 1 BOTTLETABLET, FILM COATED1503
58602-893-29Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-35Acetaminophen and Ibuprofen225 in 1 BOTTLETABLET, FILM COATED2253
58602-893-40Acetaminophen and Ibuprofen500 in 1 BOTTLETABLET, FILM COATED5003
58602-893-41Acetaminophen and Ibuprofen1000 in 1 BOTTLETABLET, FILM COATED10003
58602-893-44Acetaminophen and Ibuprofen400 in 1 BOTTLETABLET, FILM COATED4003
58602-893-46Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-46Acetaminophen and Ibuprofen18 in 1 BOTTLE, PLASTICTABLET, FILM COATED183
58602-893-49Acetaminophen and Ibuprofen10 in 1 BOTTLE, PLASTICTABLET, FILM COATED103
58602-893-49Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-51Acetaminophen and Ibuprofen216 in 1 BOTTLE, PLASTICTABLET, FILM COATED2163
58602-893-61Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-61Acetaminophen and Ibuprofen2 in 1 BLISTER PACKTABLET, FILM COATED23
58602-893-62Acetaminophen and Ibuprofen216 in 1 BOTTLETABLET, FILM COATED2163
58602-893-65Acetaminophen and Ibuprofen72 in 1 BOTTLETABLET, FILM COATED723
58602-893-65Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-73Acetaminophen and Ibuprofen20 in 1 BOTTLETABLET, FILM COATED203
58602-893-73Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-78Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-78Acetaminophen and Ibuprofen50 in 1 BOTTLE, PLASTICTABLET, FILM COATED503
58602-893-79Acetaminophen and Ibuprofen500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5003
58602-893-80Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-80Acetaminophen and Ibuprofen72 in 1 BOTTLE, PLASTICTABLET, FILM COATED723
58602-893-82Acetaminophen and Ibuprofen18 in 1 BOTTLETABLET, FILM COATED183
58602-893-82Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-84Acetaminophen and Ibuprofen225 in 1 BOTTLE, PLASTICTABLET, FILM COATED2253
58602-893-85Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-85Acetaminophen and Ibuprofen36 in 1 BOTTLE, PLASTICTABLET, FILM COATED363
58602-893-88Acetaminophen and Ibuprofen750 in 1 BOTTLETABLET, FILM COATED7503
58602-893-94Acetaminophen and Ibuprofen100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1003
58602-893-94Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-95Acetaminophen and Ibuprofen750 in 1 BOTTLE, PLASTICTABLET, FILM COATED7503
58602-893-96Acetaminophen and Ibuprofen20 in 1 BOTTLE, PLASTICTABLET, FILM COATED203
58602-893-96Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-99Acetaminophen and Ibuprofen400 in 1 BOTTLE, PLASTICTABLET, FILM COATED4003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-893ACETAMINOPHEN AND IBUPROFEN TABLET, FILM COATED [AUROHEALTH LLC]2Current NDC, 49 package rows20241228_b39fb93f-c140-40ab-8247-9559ef6df50a.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen and Ibuprofen Back PainACETAMINOPHEN AND IBUPROFENAurohealth LLC62d7ce90-63a4-4383-87c9-3a458eac29bf2026-04-28WarningsExact identifier
application applno (ANDA): 218359
application number: ANDA218359
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENAurohealth LLCb39fb93f-c140-40ab-8247-9559ef6df50a2025-07-03WarningsExact identifier
application applno (ANDA): 218359
application number: ANDA218359
ndc (product): 58602-893

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletPSNb39fb93f-c140-40ab-8247-9559ef6df50a3
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletSCDb39fb93f-c140-40ab-8247-9559ef6df50a3
2387532APAP 250 MG / ibuprofen 125 MG Oral TabletSYb39fb93f-c140-40ab-8247-9559ef6df50a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58602-893-01586020893011 BOTTLE, PLASTIC in 1 CARTON (58602-893-01) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2024-03-26NoNoCurrent
58602-893-02586020893021 BOTTLE in 1 CARTON (58602-893-02) / 144 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-12-17NoNoCurrent
58602-893-03586020893031 BOTTLE in 1 CARTON (58602-893-03) / 10 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-03-26NoNoCurrent
58602-893-07586020893071 BOTTLE in 1 CARTON (58602-893-07) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-03-26NoNoCurrent
58602-893-11586020893111 BOTTLE in 1 CARTON (58602-893-11) / 36 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-03-26NoNoCurrent
58602-893-14586020893141 BOTTLE in 1 CARTON (58602-893-14) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-03-26NoNoCurrent
58602-893-21586020893211 BOTTLE in 1 CARTON (58602-893-21) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-03-26NoNoCurrent
58602-893-29586020893291 BOTTLE in 1 CARTON (58602-893-29) / 150 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-03-26NoNoCurrent
58602-893-3558602089335225 TABLET, FILM COATED in 1 BOTTLE (58602-893-35) 2024-03-26NoNoCurrent
58602-893-4058602089340500 TABLET, FILM COATED in 1 BOTTLE (58602-893-40) 2024-03-26NoNoCurrent
58602-893-41586020893411000 TABLET, FILM COATED in 1 BOTTLE (58602-893-41) 2024-03-26NoNoCurrent
58602-893-4458602089344400 TABLET, FILM COATED in 1 BOTTLE (58602-893-44) 2024-03-26NoNoCurrent
58602-893-46586020893461 BOTTLE, PLASTIC in 1 CARTON (58602-893-46) / 18 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2024-03-26NoNoCurrent
58602-893-49586020893491 BOTTLE, PLASTIC in 1 CARTON (58602-893-49) / 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2024-03-26NoNoCurrent
58602-893-5158602089351216 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-893-51) 2024-03-26NoNoCurrent
58602-893-61586020893611 BLISTER PACK in 1 CARTON (58602-893-61) / 2 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2024-03-26NoNoCurrent
58602-893-6258602089362216 TABLET, FILM COATED in 1 BOTTLE (58602-893-62) 2024-03-26NoNoCurrent
58602-893-65586020893651 BOTTLE in 1 CARTON (58602-893-65) / 72 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-03-26NoNoCurrent
58602-893-73586020893731 BOTTLE in 1 CARTON (58602-893-73) / 20 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-03-26NoNoCurrent
58602-893-78586020893781 BOTTLE, PLASTIC in 1 CARTON (58602-893-78) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2024-03-26NoNoCurrent
58602-893-7958602089379500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-893-79) 2024-03-26NoNoCurrent
58602-893-80586020893801 BOTTLE, PLASTIC in 1 CARTON (58602-893-80) / 72 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2024-03-26NoNoCurrent
58602-893-82586020893821 BOTTLE in 1 CARTON (58602-893-82) / 18 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-03-26NoNoCurrent
58602-893-8458602089384225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-893-84) 2024-03-26NoNoCurrent
58602-893-85586020893851 BOTTLE, PLASTIC in 1 CARTON (58602-893-85) / 36 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2024-03-26NoNoCurrent
58602-893-8858602089388750 TABLET, FILM COATED in 1 BOTTLE (58602-893-88) 2024-03-26NoNoCurrent
58602-893-94586020893941 BOTTLE, PLASTIC in 1 CARTON (58602-893-94) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2024-03-26NoNoCurrent
58602-893-9558602089395750 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-893-95) 2024-03-26NoNoCurrent
58602-893-96586020893961 BOTTLE, PLASTIC in 1 CARTON (58602-893-96) / 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2024-03-26NoNoCurrent
58602-893-9958602089399400 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-893-99) 2024-03-26NoNoCurrent