Home NDC 66715-9601 Advil Dual Action with Acetaminophen
Product NDC 66715-9601
11-digit product format 667159601
Labeler code 66715
Product ID 66715-9601_44e71018-211d-caf8-e063-6394a90a06c9
Type HUMAN OTC DRUG
Nonproprietary name ibuprofen, acetaminophen tablet, film coated
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Lil' Drug Store Products, Inc.
Application NDA211733
Marketing category NDA
Marketing start 2023-05-17
Substance IBUPROFEN; ACETAMINOPHEN
Active strength 125; 250 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-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 2026-09-14 22:38:34 2026-08 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN 250MG;125MG TABLET / ORAL RLD, RS 2020-02-28 caaa826d4ba7…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 2026-09-14 22:38:34 2026-08 N211733-001 11918693 2041-07-09 Drug product 2024-03-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211733-001 11918693 2041-07-09 Drug product 2024-03-26 caaa826d4ba7…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# 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 Advil Dual Action with Acetaminophen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 125 mg/1 ACETAMINOPHEN 250 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 66715-9601-2 Advil Dual Action with Acetaminophen 2 in 1 CARTON TABLET, FILM COATED 2 4 66715-9601-2 Advil Dual Action with Acetaminophen 2 in 1 POUCH TABLET, FILM COATED 2 4 66715-9601-3 Advil Dual Action with Acetaminophen 2 in 1 POUCH TABLET, FILM COATED 2 4 66715-9601-3 Advil Dual Action with Acetaminophen 3 in 1 CARTON TABLET, FILM COATED 3 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66715-9601 ADVIL DUAL ACTION WITH ACETAMINOPHEN (IBUPROFEN, ACETAMINOPHEN TABLET, FILM COATED) TABLET, FILM COATED ADVIL DUAL ACTION WITH ACETAMINOPHEN, TRAVEL BASIX (IBUPROFEN, ACETAMINOPHEN TABLET, FILM COATED) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.] 3 Current NDC, 4 package rows 20241121_030d9bca-a934-6ef9-e063-6394a90a8277.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 ndc (product): 66715-9601 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 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 Sample Exclude flag Status 66715-9601-2 66715960102 2 POUCH in 1 CARTON (66715-9601-2) / 2 TABLET, FILM COATED in 1 POUCH 2 pouch 2025-01-07 No No Current 66715-9601-3 66715960103 3 POUCH in 1 CARTON (66715-9601-3) / 2 TABLET, FILM COATED in 1 POUCH 3 pouch 2023-05-17 No No Current