ADVIL DUAL ACTION WITH ACETAMINOPHEN

Manufacturer
Haleon US Holdings LLC
Effective date
2024-04-24
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:11:26

Label at a glance#

ProductADVIL DUAL ACTION WITH ACETAMINOPHEN Back Pain
Active ingredientIBUPROFEN, ACETAMINOPHEN
Label structure9 sections

Storage and handling

Other information • read all warnings and directions before use. Keep carton. • store at 20-25°C (68-77°F) • avoid excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 250 mg

Ibuprofen 125 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Pain reliever

Pain reliever

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves minor aches and pains due to:
    • backache
    • muscular aches
    • minor pain of arthritis
    • headache
    • toothache
    • menstrual cramps

WARNINGS SECTION

Warnings

Acetaminophen liver damage warning:

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if you take:

  • with other drugs containing acetaminophen
  • more than 6 caplets in 24 hours, which is the maximum daily amount for this product
  • 3 or more alcoholic drinks every day while using this product

SPL UNCLASSIFIED SECTION

Acetaminophen allergy alert: may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If skin reaction occurs, stop use and seek medical help right away.

SPL UNCLASSIFIED SECTION

NSAID allergy alert: ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters

If an allergic reaction occurs, stop use and seek medical help right away.

NSAID stomach bleeding warning

SPL UNCLASSIFIED SECTION

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Heart attack and stroke warning:

SPL UNCLASSIFIED SECTION

NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
  • if you have ever had an allergic reaction to acetaminophen or any other pain reliever
  • right before or after heart surgery

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • you have liver disease
  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • under a doctor's care for any serious condition
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug

When using this product

OTC - WHEN USING SECTION

  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • leg swelling
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present in the painful area
  • any new symptoms appear

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in

pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not take more than directed

adults and children

12 years and over

  • take 2 caplets every 8 hours while symptoms persist

children under 12 years

  • ask a doctor
  • do not take more than 6 caplets in 24 hours, unless directed by a doctor

STORAGE AND HANDLING SECTION

Other information

  • read all warnings and directions before use. Keep carton.
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, ferric oxides, glyceryl dibehenate, hypromellose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments?

call weekdays 9 AM to 5 PM at 1-800-88-ADVIL

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

Advil
DUAL ACTION
WITH Acetaminophen

BACK PAIN

Acetaminophen 250 mg and
Ibuprofen (NSAID) 125 mg Tablets
8 HOUR RELIEF

144
Caplets*
*Capsule-Shaped Tablets

000065288 Front Carton

Advil Dual Action with Aceta Back Pain 144 Caplets
Advil Dual Action with Aceta Back Pain 144 Caplets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletPSN4
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletSCD4
2387532APAP 250 MG / ibuprofen 125 MG Oral TabletSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
IBUPROFEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0573-0145-022024-01-31C16284748780-11030e365-4d35-111a-e063-dadaa90a10e2Drug Facts
0573-0145-182024-01-31C16284748780-11030e365-4d35-111a-e063-dadaa90a10e2Drug Facts
0573-0145-722024-01-31C16284748780-11030e365-4d35-111a-e063-dadaa90a10e2Drug Facts
0573-0145-892024-01-31C16284748780-11030e365-4d35-111a-e063-dadaa90a10e2Drug Facts

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 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

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0573-01450573-0145-18, 0573-0145-72, 0573-0145-89, 0573-0145-02, 0573-0145-99

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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
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
2026-09-14 22:38:342026-08N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-2884e616aacf4f…
2026-08-18 06:07:402026-07N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28caaa826d4ba7…
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
2026-09-14 22:38:342026-08N211733-001119186932041-07-09Drug product2024-03-2684e616aacf4f…
2026-08-18 06:07:402026-07N211733-001119186932041-07-09Drug product2024-03-26caaa826d4ba7…
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…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ADVIL DUAL ACTION WITH ACETAMINOPHEN Back PainIBUPROFEN, ACETAMINOPHENHaleon US Holdings LLCacaa9806-e552-44f2-a680-b8bb64c49e1f2024-04-24WarningsExact identifier
ndc (package): 0573-0145-89
ndc (package): 0573-0145-99
ndc (package): 0573-0145-72
ndc (package): 0573-0145-18
ndc (package): 0573-0145-02
ndc (product): 0573-0145
ndc11 (package): 00573014518
ndc11 (package): 00573014589
ndc11 (package): 00573014502
ndc11 (package): 00573014599
ndc11 (package): 00573014572
spl id: 9c2623fc-aba0-4ae6-bb1e-e1e52f47b09c
spl set id: acaa9806-e552-44f2-a680-b8bb64c49e1f

Reported adverse events (FAERS/openFDA)#

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