Home NDC 0573-0147 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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN ACETAMINOPHEN; IBUPROFEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N211733-001 11918693 2041-07-09 Drug product 2024-03-26
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N211733-001 11918693 2041-07-09 Drug product 2024-03-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211733-001 11918693 2041-07-09 Drug product 2024-03-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211733-001 11918693 2041-07-09 Drug product 2024-03-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211733-001 11918693 2041-07-09 Drug product 2024-03-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211733-001 11918693 2041-07-09 Drug product 2024-03-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211733-001 11918693 2041-07-09 Drug product 2024-03-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211733-001 11918693 2041-07-09 Drug product 2024-03-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211733-001 11918693 2041-07-09 Drug product 2024-03-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211733-001 11918693 2041-07-09 Drug product 2024-03-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211733-001 11918693 2041-07-09 Drug product 2024-03-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211733-001 11918693 2041-07-09 Drug product 2024-03-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211733-001 11918693 2041-07-09 Drug product 2024-03-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211733-001 11918693 2041-07-09 Drug product 2024-03-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211733-001 11918693 2041-07-09 Drug product 2024-03-26 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N211733-001 11918693 2041-07-09 Drug product 2024-03-26 a50c72e98297…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base ADVIL DUAL ACTION WITH ACETAMINOPHEN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 250 mg/1 ACETAMINOPHEN 125 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WK2XYI10QM Internal UNII lookup 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2387532 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0573-0147-09 ADVIL DUAL ACTION WITH ACETAMINOPHEN 8 in 1 BOTTLE TABLET, FILM COATED 8 11 0573-0147-18 ADVIL DUAL ACTION WITH ACETAMINOPHEN 1 in 1 CARTON TABLET, FILM COATED 1 11 0573-0147-18 ADVIL DUAL ACTION WITH ACETAMINOPHEN 18 in 1 BOTTLE TABLET, FILM COATED 18 11 0573-0147-24 ADVIL DUAL ACTION WITH ACETAMINOPHEN 24 in 1 BOTTLE TABLET, FILM COATED 24 11 0573-0147-24 ADVIL DUAL ACTION WITH ACETAMINOPHEN 1 in 1 CARTON TABLET, FILM COATED 1 11 0573-0147-36 ADVIL DUAL ACTION WITH ACETAMINOPHEN 36 in 1 BOTTLE TABLET, FILM COATED 36 11 0573-0147-36 ADVIL DUAL ACTION WITH ACETAMINOPHEN 1 in 1 CARTON TABLET, FILM COATED 1 11 0573-0147-72 ADVIL DUAL ACTION WITH ACETAMINOPHEN 1 in 1 CARTON TABLET, FILM COATED 1 11 0573-0147-72 ADVIL DUAL ACTION WITH ACETAMINOPHEN 72 in 1 BOTTLE TABLET, FILM COATED 72 11 0573-0147-86 ADVIL DUAL ACTION WITH ACETAMINOPHEN 1 in 1 CARTON TABLET, FILM COATED 1 11 0573-0147-86 ADVIL DUAL ACTION WITH ACETAMINOPHEN 216 in 1 BOTTLE TABLET, FILM COATED 216 11 0573-0147-90 ADVIL DUAL ACTION WITH ACETAMINOPHEN 1 in 1 CARTON TABLET, FILM COATED 1 11 0573-0147-90 ADVIL DUAL ACTION WITH ACETAMINOPHEN 90 in 1 BOTTLE TABLET, FILM COATED 90 11 0573-0147-91 ADVIL DUAL ACTION WITH ACETAMINOPHEN 3000 in 1 CASE TABLET, FILM COATED 3000 11 0573-0147-91 ADVIL DUAL ACTION WITH ACETAMINOPHEN 2 in 1 POUCH TABLET, FILM COATED 2 11 0573-0147-93 ADVIL DUAL ACTION WITH ACETAMINOPHEN 1 in 1 CARTON TABLET, FILM COATED 1 11 0573-0147-93 ADVIL DUAL ACTION WITH ACETAMINOPHEN 162 in 1 BOTTLE TABLET, FILM COATED 162 11 0573-0147-94 ADVIL DUAL ACTION WITH ACETAMINOPHEN 144 in 1 BOTTLE TABLET, FILM COATED 144 11 0573-0147-94 ADVIL DUAL ACTION WITH ACETAMINOPHEN 1 in 1 CARTON TABLET, FILM COATED 1 11 0573-0147-95 ADVIL DUAL ACTION WITH ACETAMINOPHEN 50 in 1 CARTON TABLET, FILM COATED 50 11 0573-0147-95 ADVIL DUAL ACTION WITH ACETAMINOPHEN 2 in 1 POUCH TABLET, FILM COATED 2 11 0573-0147-97 ADVIL DUAL ACTION WITH ACETAMINOPHEN 240 in 1 BOTTLE TABLET, FILM COATED 240 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0573-0147 ADVIL DUAL ACTION WITH ACETAMINOPHEN (IBUPROFEN, ACETAMINOPHEN) TABLET, FILM COATED [HALEON US HOLDINGS LLC] 11 Current NDC, Legacy NDC, 22 package rows 20250423_f5ea858e-76d9-4777-b3dc-5d614f66d485.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ADVIL DUAL ACTION WITH ACETAMINOPHEN IBUPROFEN, ACETAMINOPHEN Select Consumer Group 55cd65fc-91bf-4979-e063-6294a90ab9b7 2026-07-04 Warnings Exact identifier application applno (NDA): 211733 application number: NDA211733 Advil Dual Action with Acetaminophen, Travel BASIX IBUPROFEN, ACETAMINOPHEN TABLET, FILM COATED Lil' Drug Store Products, Inc. 030d9bca-a934-6ef9-e063-6394a90a8277 2025-12-01 Warnings Exact identifier application applno (NDA): 211733 application number: NDA211733 ADVIL DUAL ACTION WITH ACETAMINOPHEN IBUPROFEN, ACETAMINOPHEN Haleon US Holdings LLC f5ea858e-76d9-4777-b3dc-5d614f66d485 2025-04-21 Warnings Exact identifier application applno (NDA): 211733 application number: NDA211733 ndc (product): 0573-0147 ADVIL DUAL ACTION WITH ACETAMINOPHEN Back Pain IBUPROFEN, ACETAMINOPHEN Haleon US Holdings LLC acaa9806-e552-44f2-a680-b8bb64c49e1f 2024-04-24 Warnings Exact identifier application applno (NDA): 211733 application number: NDA211733 ADVIL DUAL ACTION WITH ACETAMINOPHEN IBUPROFEN, ACETAMINOPHEN Navajo Manufacturing Company Inc. bd0d7812-4e42-b533-e053-2995a90ae1f9 2024-04-15 Warnings Exact identifier application applno (NDA): 211733 application number: NDA211733
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0573-0147-09 00573014709 8 TABLET, FILM COATED in 1 BOTTLE (0573-0147-09) 2023-05-15 No No Current 0573-0147-18 00573014718 1 BOTTLE in 1 CARTON (0573-0147-18) / 18 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2020-07-27 0000-00-00 No No Current 0573-0147-24 00573014724 1 BOTTLE in 1 CARTON (0573-0147-24) / 24 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2021-09-06 No No Current 0573-0147-36 00573014736 1 BOTTLE in 1 CARTON (0573-0147-36) / 36 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2020-07-27 0000-00-00 No No Current 0573-0147-72 00573014772 1 BOTTLE in 1 CARTON (0573-0147-72) / 72 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2020-07-27 0000-00-00 No No Current 0573-0147-86 00573014786 1 BOTTLE in 1 CARTON (0573-0147-86) / 216 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2020-07-27 0000-00-00 No No Current 0573-0147-90 00573014790 1 BOTTLE in 1 CARTON (0573-0147-90) / 90 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2024-04-08 No No Current 0573-0147-91 00573014791 3000 POUCH in 1 CASE (0573-0147-91) / 2 TABLET, FILM COATED in 1 POUCH 3000 pouch 2023-05-15 No No Current 0573-0147-93 00573014793 1 BOTTLE in 1 CARTON (0573-0147-93) / 162 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2024-04-09 No No Current 0573-0147-94 00573014794 1 BOTTLE in 1 CARTON (0573-0147-94) / 144 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2020-07-27 0000-00-00 No No Current 0573-0147-95 00573014795 50 POUCH in 1 CARTON (0573-0147-95) / 2 TABLET, FILM COATED in 1 POUCH 50 pouch 2020-07-27 0000-00-00 No No Current 0573-0147-97 00573014797 240 TABLET, FILM COATED in 1 BOTTLE (0573-0147-97) 2025-03-15 No No Current