FDA.reportPublic FDA data

ADVIL DUAL ACTION WITH ACETAMINOPHEN

Product NDC
0573-0147
11-digit product format
005730147
Labeler code
0573
Product ID
0573-0147_440b1444-9b6d-44c2-8ec4-dbb66ebb5025
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
2020-07-27
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

Additional Listing Data#

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

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, WK2XYI10QM
Rxcui2387532

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
0573-0147-092024-01-31C16284748780-11030e365-31fd-111a-e063-dadaa90a10e2Drug Facts
0573-0147-182024-01-31C16284748780-11030e365-31fd-111a-e063-dadaa90a10e2Drug Facts
0573-0147-362024-01-31C16284748780-11030e365-31fd-111a-e063-dadaa90a10e2Drug Facts
0573-0147-722024-01-31C16284748780-11030e365-31fd-111a-e063-dadaa90a10e2Drug Facts
0573-0147-862024-01-31C16284748780-11030e365-31fd-111a-e063-dadaa90a10e2Drug Facts
0573-0147-912024-01-31C16284748780-11030e365-31fd-111a-e063-dadaa90a10e2Drug Facts
0573-0147-942024-01-31C16284748780-11030e365-31fd-111a-e063-dadaa90a10e2Drug Facts
0573-0147-952024-01-31C16284748780-11030e365-31fd-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0147-09ADVIL DUAL ACTION WITH ACETAMINOPHEN8 in 1 BOTTLETABLET, FILM COATED811
0573-0147-18ADVIL DUAL ACTION WITH ACETAMINOPHEN1 in 1 CARTONTABLET, FILM COATED111
0573-0147-18ADVIL DUAL ACTION WITH ACETAMINOPHEN18 in 1 BOTTLETABLET, FILM COATED1811
0573-0147-24ADVIL DUAL ACTION WITH ACETAMINOPHEN24 in 1 BOTTLETABLET, FILM COATED2411
0573-0147-24ADVIL DUAL ACTION WITH ACETAMINOPHEN1 in 1 CARTONTABLET, FILM COATED111
0573-0147-36ADVIL DUAL ACTION WITH ACETAMINOPHEN36 in 1 BOTTLETABLET, FILM COATED3611
0573-0147-36ADVIL DUAL ACTION WITH ACETAMINOPHEN1 in 1 CARTONTABLET, FILM COATED111
0573-0147-72ADVIL DUAL ACTION WITH ACETAMINOPHEN1 in 1 CARTONTABLET, FILM COATED111
0573-0147-72ADVIL DUAL ACTION WITH ACETAMINOPHEN72 in 1 BOTTLETABLET, FILM COATED7211
0573-0147-86ADVIL DUAL ACTION WITH ACETAMINOPHEN1 in 1 CARTONTABLET, FILM COATED111
0573-0147-86ADVIL DUAL ACTION WITH ACETAMINOPHEN216 in 1 BOTTLETABLET, FILM COATED21611
0573-0147-90ADVIL DUAL ACTION WITH ACETAMINOPHEN1 in 1 CARTONTABLET, FILM COATED111
0573-0147-90ADVIL DUAL ACTION WITH ACETAMINOPHEN90 in 1 BOTTLETABLET, FILM COATED9011
0573-0147-91ADVIL DUAL ACTION WITH ACETAMINOPHEN3000 in 1 CASETABLET, FILM COATED300011
0573-0147-91ADVIL DUAL ACTION WITH ACETAMINOPHEN2 in 1 POUCHTABLET, FILM COATED211
0573-0147-93ADVIL DUAL ACTION WITH ACETAMINOPHEN1 in 1 CARTONTABLET, FILM COATED111
0573-0147-93ADVIL DUAL ACTION WITH ACETAMINOPHEN162 in 1 BOTTLETABLET, FILM COATED16211
0573-0147-94ADVIL DUAL ACTION WITH ACETAMINOPHEN144 in 1 BOTTLETABLET, FILM COATED14411
0573-0147-94ADVIL DUAL ACTION WITH ACETAMINOPHEN1 in 1 CARTONTABLET, FILM COATED111
0573-0147-95ADVIL DUAL ACTION WITH ACETAMINOPHEN50 in 1 CARTONTABLET, FILM COATED5011
0573-0147-95ADVIL DUAL ACTION WITH ACETAMINOPHEN2 in 1 POUCHTABLET, FILM COATED211
0573-0147-97ADVIL DUAL ACTION WITH ACETAMINOPHEN240 in 1 BOTTLETABLET, FILM COATED24011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0147-09EA - Each0573-0147594ad440-0e6d-4409-8126-29af7eeb6c6412024-12-10
0573-0147-86EA - Each0573-0147203f8a8a-d4e6-4f58-8405-8a84dc3a904012024-12-10
0573-0147-94EA - Each0573-01470600a503-4311-4e1a-9f4d-3fe895b9ae3b12021-10-08
0573-0147-95EA - Each0573-01478987ba23-fe04-4d0a-9a96-921186f6c1e912024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0147ADVIL DUAL ACTION WITH ACETAMINOPHEN (IBUPROFEN, ACETAMINOPHEN) TABLET, FILM COATED [HALEON US HOLDINGS LLC]11Current NDC, Legacy NDC, 22 package rows20250423_f5ea858e-76d9-4777-b3dc-5d614f66d485.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletPSNf5ea858e-76d9-4777-b3dc-5d614f66d48511
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletSCDf5ea858e-76d9-4777-b3dc-5d614f66d48511
2387532APAP 250 MG / ibuprofen 125 MG Oral TabletSYf5ea858e-76d9-4777-b3dc-5d614f66d48511
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletPSNbd0d7812-4e42-b533-e053-2995a90ae1f93
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletSCDbd0d7812-4e42-b533-e053-2995a90ae1f93
2387532APAP 250 MG / ibuprofen 125 MG Oral TabletSYbd0d7812-4e42-b533-e053-2995a90ae1f93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-0147-09005730147098 TABLET, FILM COATED in 1 BOTTLE (0573-0147-09) 2023-05-15NoNoCurrent
0573-0147-18005730147181 BOTTLE in 1 CARTON (0573-0147-18) / 18 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-07-270000-00-00NoNoCurrent
0573-0147-24005730147241 BOTTLE in 1 CARTON (0573-0147-24) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-09-06NoNoCurrent
0573-0147-36005730147361 BOTTLE in 1 CARTON (0573-0147-36) / 36 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-07-270000-00-00NoNoCurrent
0573-0147-72005730147721 BOTTLE in 1 CARTON (0573-0147-72) / 72 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-07-270000-00-00NoNoCurrent
0573-0147-86005730147861 BOTTLE in 1 CARTON (0573-0147-86) / 216 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-07-270000-00-00NoNoCurrent
0573-0147-90005730147901 BOTTLE in 1 CARTON (0573-0147-90) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-04-08NoNoCurrent
0573-0147-91005730147913000 POUCH in 1 CASE (0573-0147-91) / 2 TABLET, FILM COATED in 1 POUCH3000 pouch2023-05-15NoNoCurrent
0573-0147-93005730147931 BOTTLE in 1 CARTON (0573-0147-93) / 162 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-04-09NoNoCurrent
0573-0147-94005730147941 BOTTLE in 1 CARTON (0573-0147-94) / 144 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-07-270000-00-00NoNoCurrent
0573-0147-950057301479550 POUCH in 1 CARTON (0573-0147-95) / 2 TABLET, FILM COATED in 1 POUCH50 pouch2020-07-270000-00-00NoNoCurrent
0573-0147-9700573014797240 TABLET, FILM COATED in 1 BOTTLE (0573-0147-97) 2025-03-15NoNoCurrent