ADVIL DUAL ACTION WITH ACETAMINOPHEN

Product NDC
0573-0145
11-digit product format
005730145
Labeler code
0573
Product ID
0573-0145_9c2623fc-aba0-4ae6-bb1e-e1e52f47b09c
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen, Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
NDA211733
Marketing category
NDA
Marketing start
2023-01-16
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 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
N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHENACETAMINOPHEN; IBUPROFEN250MG;125MGTABLET / ORALRLD, RS2020-02-28

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N211733-001119186932041-07-09Drug product2024-03-26

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
2026-02-19 14:30 UTC2026-02N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-284b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-283f0d92c62455…
2023-05-13 08:27 UTC2023-05N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28053a50430f4f…
2023-01-26 05:58 UTC2023-01N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N211733-001119186932041-07-09Drug product2024-03-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211733-001119186932041-07-09Drug product2024-03-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N211733-001119186932041-07-09Drug product2024-03-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211733-001119186932041-07-09Drug product2024-03-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211733-001119186932041-07-09Drug product2024-03-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211733-001119186932041-07-09Drug product2024-03-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211733-001119186932041-07-09Drug product2024-03-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211733-001119186932041-07-09Drug product2024-03-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211733-001119186932041-07-09Drug product2024-03-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N211733-001119186932041-07-09Drug product2024-03-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211733-001119186932041-07-09Drug product2024-03-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211733-001119186932041-07-09Drug product2024-03-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211733-001119186932041-07-09Drug product2024-03-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05N211733-001119186932041-07-09Drug product2024-03-268072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N211733-001119186932041-07-09Drug product2024-03-26a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N211733-001NP2023-02-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N211733-001NP2023-02-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N211733-001NP2023-02-284b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N211733-001NP2023-02-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N211733-001NP2023-02-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N211733-001NP2023-02-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N211733-001NP2023-02-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N211733-001NP2023-02-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N211733-001NP2023-02-28c0c555d07b60…
2023-12-20 04:57 UTC2023-12N211733-001NP2023-02-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N211733-001NP2023-02-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N211733-001NP2023-02-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N211733-001NP2023-02-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N211733-001NP2023-02-283f0d92c62455…
2023-05-13 08:27 UTC2023-05N211733-001NP2023-02-28053a50430f4f…
2023-01-26 05:58 UTC2023-01N211733-001NP2023-02-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N211733-001NP2023-02-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N211733-001NP2023-02-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N211733-001NP2023-02-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N211733-001NP2023-02-28cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
ADVIL DUAL ACTION WITH ACETAMINOPHEN
Brand name suffix
Back Pain
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN250 mg/1
ACETAMINOPHEN125 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WK2XYI10QMInternal UNII lookup
362O9ITL9DInternal 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
acaa9806-e552-44f2-a680-b8bb64c49e1fAvailable 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0145-02ADVIL DUAL ACTION WITH ACETAMINOPHENBack Pain2 in 1 POUCHTABLET, FILM COATED24
0573-0145-18ADVIL DUAL ACTION WITH ACETAMINOPHENBack Pain1 in 1 CARTONTABLET, FILM COATED14
0573-0145-18ADVIL DUAL ACTION WITH ACETAMINOPHENBack Pain18 in 1 BOTTLETABLET, FILM COATED184
0573-0145-72ADVIL DUAL ACTION WITH ACETAMINOPHENBack Pain72 in 1 BOTTLETABLET, FILM COATED724
0573-0145-72ADVIL DUAL ACTION WITH ACETAMINOPHENBack Pain1 in 1 CARTONTABLET, FILM COATED14
0573-0145-89ADVIL DUAL ACTION WITH ACETAMINOPHENBack Pain1 in 1 CARTONTABLET, FILM COATED14
0573-0145-89ADVIL DUAL ACTION WITH ACETAMINOPHENBack Pain144 in 1 BOTTLETABLET, FILM COATED1444
0573-0145-99ADVIL DUAL ACTION WITH ACETAMINOPHENBack Pain3000 in 1 CASETABLET, FILM COATED30004
0573-0145-99ADVIL DUAL ACTION WITH ACETAMINOPHENBack Pain2 in 1 POUCHTABLET, FILM COATED24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0145-18EA - Each0573-0145cf7d93ae-673b-42b5-a328-eca6691e035312025-01-14
0573-0145-72EA - Each0573-01455d423cbd-3cab-403f-a20b-92e6670ae9b112024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0145ADVIL DUAL ACTION WITH ACETAMINOPHEN BACK PAIN (IBUPROFEN, ACETAMINOPHEN) TABLET, FILM COATED [HALEON US HOLDINGS LLC]4Current NDC, 9 package rows20240426_acaa9806-e552-44f2-a680-b8bb64c49e1f.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
ADVIL DUAL ACTION WITH ACETAMINOPHENIBUPROFEN, ACETAMINOPHENSelect Consumer Group55cd65fc-91bf-4979-e063-6294a90ab9b72026-07-04WarningsExact identifier
application applno (NDA): 211733
application number: NDA211733
Advil Dual Action with Acetaminophen, Travel BASIXIBUPROFEN, ACETAMINOPHEN TABLET, FILM COATEDLil' Drug Store Products, Inc.030d9bca-a934-6ef9-e063-6394a90a82772025-12-01WarningsExact identifier
application applno (NDA): 211733
application number: NDA211733
ADVIL DUAL ACTION WITH ACETAMINOPHENIBUPROFEN, ACETAMINOPHENHaleon US Holdings LLCf5ea858e-76d9-4777-b3dc-5d614f66d4852025-04-21WarningsExact identifier
application applno (NDA): 211733
application number: NDA211733
ADVIL DUAL ACTION WITH ACETAMINOPHEN Back PainIBUPROFEN, ACETAMINOPHENHaleon US Holdings LLCacaa9806-e552-44f2-a680-b8bb64c49e1f2024-04-24WarningsExact identifier
application applno (NDA): 211733
application number: NDA211733
ndc (product): 0573-0145
ADVIL DUAL ACTION WITH ACETAMINOPHENIBUPROFEN, ACETAMINOPHENNavajo Manufacturing Company Inc.bd0d7812-4e42-b533-e053-2995a90ae1f92024-04-15WarningsExact identifier
application applno (NDA): 211733
application number: NDA211733

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletPSNacaa9806-e552-44f2-a680-b8bb64c49e1f4
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletSCDacaa9806-e552-44f2-a680-b8bb64c49e1f4
2387532APAP 250 MG / ibuprofen 125 MG Oral TabletSYacaa9806-e552-44f2-a680-b8bb64c49e1f4
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletPSN68d3be55-9340-4cc9-a05a-12b9338ddc562
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletSCD68d3be55-9340-4cc9-a05a-12b9338ddc562
2387532APAP 250 MG / ibuprofen 125 MG Oral TabletSY68d3be55-9340-4cc9-a05a-12b9338ddc562

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0573-0145-02005730145022 TABLET, FILM COATED in 1 POUCH (0573-0145-02) 2023-01-16NoNoCurrent
0573-0145-18005730145181 BOTTLE in 1 CARTON (0573-0145-18) / 18 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-01-16NoNoCurrent
0573-0145-72005730145721 BOTTLE in 1 CARTON (0573-0145-72) / 72 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-01-16NoNoCurrent
0573-0145-89005730145891 BOTTLE in 1 CARTON (0573-0145-89) / 144 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-01-16NoNoCurrent
0573-0145-99005730145993000 POUCH in 1 CASE (0573-0145-99) / 2 TABLET, FILM COATED in 1 POUCH3000 pouch2023-01-16NoNoCurrent