Home NDC 50580-208 Motrin Dual Action With Tylenol
Product NDC 50580-208
11-digit product format 505800208
Labeler code 50580
Product ID 50580-208_48d075d6-52f3-6fd7-e063-6394a90ada71
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen and Ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Kenvue Brands LLC
Application ANDA214836
Marketing category ANDA
Marketing start 2023-03-20
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 2027-12-31
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 A214836-001 ACETAMINOPHEN AND IBUPROFEN ACETAMINOPHEN; IBUPROFEN 250MG;125MG TABLET / ORAL 2023-02-28
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 A214836-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-02-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214836-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-02-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214836-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214836-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214836-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214836-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214836-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214836-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214836-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-02-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214836-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-02-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214836-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-02-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214836-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-02-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214836-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-02-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214836-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-02-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214836-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-02-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214836-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-02-28 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214836-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-02-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214836-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-02-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214836-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-02-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214836-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-02-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214836-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-02-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214836-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-02-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214836-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-02-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214836-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-02-28 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214836-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-02-28 a50c72e98297…
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 Motrin Dual Action With Tylenol
Listing expiration 2027-12-31 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50580-208-02 Motrin Dual Action With Tylenol 1 in 1 CARTON TABLET, FILM COATED 1 7 50580-208-02 Motrin Dual Action With Tylenol 20 in 1 BOTTLE TABLET, FILM COATED 20 7 50580-208-08 Motrin Dual Action With Tylenol 80 in 1 BOTTLE TABLET, FILM COATED 80 7 50580-208-08 Motrin Dual Action With Tylenol 1 in 1 CARTON TABLET, FILM COATED 1 7 50580-208-12 Motrin Dual Action With Tylenol 1 in 1 CARTON TABLET, FILM COATED 1 7 50580-208-12 Motrin Dual Action With Tylenol 120 in 1 BOTTLE TABLET, FILM COATED 120 7 50580-208-16 Motrin Dual Action With Tylenol 2 in 1 CARTON TABLET, FILM COATED 2 7 50580-208-16 Motrin Dual Action With Tylenol 1 in 1 CARTON TABLET, FILM COATED 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-208 MOTRIN DUAL ACTION WITH TYLENOL (ACETAMINOPHEN AND IBUPROFEN) TABLET, FILM COATED [KENVUE BRANDS LLC] 6 Current NDC, 8 package rows 20250315_f2ee9cf5-02b7-6612-e053-2995a90a90c4.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 2 · 26 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join dual action ACETAMINOPHEN, IBUPROFEN Rite Aid Corporation 54b08d24-d5e9-4111-9d97-329896e8309d 2026-09-09 Warnings Exact identifier application applno (ANDA): 214836 application number: ANDA214836 equaline dual action pain reliever ACETAMINOPHEN, IBUPROFEN United Natural Foods, Inc. dba UNFI ae0dc3f1-ee6f-4347-af5d-70f45dd68bdb 2026-08-27 Warnings Exact identifier application applno (ANDA): 214836 application number: ANDA214836 foster and thrive dual action ACETAMINOPHEN, IBUPROFEN Strategic Sourcing Services LLC f970d423-1d92-40c0-8358-91d1f963505c 2026-08-26 Warnings Exact identifier application applno (ANDA): 214836 application number: ANDA214836 Pain Reliever ACETAMINOPHEN, IBUPROFEN CVS Pharmacy 9126e680-d5ff-4189-9f9a-d797822ce670 2026-08-26 Warnings Exact identifier application applno (ANDA): 214836 application number: ANDA214836 Leader Dual Action Pain Reliever ACETAMINOPHEN, IBUPROFEN Cardinal Health 110, LLC. dba Leader 2bb1f616-48af-4fe1-9aa9-32fcb2dba50c 2026-08-26 Warnings Exact identifier application applno (ANDA): 214836 application number: ANDA214836 dual pain reliever ACETAMINOPHEN, IBUPROFEN Walgreen Company 5cb3b0b4-5b47-4ed4-a5e3-f14dbbcb46df 2026-08-26 Warnings Exact identifier application applno (ANDA): 214836 application number: ANDA214836 good sense dual action ACETAMINOPHEN, IBUPROFEN L Perrigo Company b117358c-f4ca-4ea8-95ee-88a42cc05040 2026-07-17 Warnings Exact identifier application applno (ANDA): 214836 application number: ANDA214836 dual action ACETAMINOPHEN, IBUPROFEN Publix Super Markets Inc e185d119-3484-40b1-afb8-6dca49d45e40 2026-06-04 Warnings Exact identifier application applno (ANDA): 214836 application number: ANDA214836 dual pain reliever ACETAMINOPHEN, IBUPROFEN Meijer, Inc. db1dc4f6-23ec-4a04-baa8-ffa739bce76a 2026-06-04 Warnings Exact identifier application applno (ANDA): 214836 application number: ANDA214836 DUAL ACTION ACETAMINOPHEN, IBUPROFEN Amazon.com Services LLC 20fe6b3f-e5a6-47d4-a371-9172408fbc46 2026-06-04 Warnings Exact identifier application applno (ANDA): 214836 application number: ANDA214836 acetaminophen and ibuprofen ACETAMINOPHEN, IBUPROFEN Kroger Company e6c0cca6-812e-4bea-86b0-e15b10f3f0d4 2026-06-04 Warnings Exact identifier application applno (ANDA): 214836 application number: ANDA214836 topcare dual action ACETAMINOPHEN, IBUPROFEN Topco Associates LLC dddc04c4-d500-4d42-8406-89f27a9ad651 2026-06-04 Warnings Exact identifier application applno (ANDA): 214836 application number: ANDA214836 DUAL ACTION BACK PAIN RELIEVER ACETAMINOPHEN, IBUPROFEN Meijer, Inc. 8d9a0c56-ef22-45a6-8b1d-d2b2f3247210 2026-03-19 Warnings Exact identifier application applno (ANDA): 214836 application number: ANDA214836 DUAL ACTION ACETAMINOPHEN, IBUPROFEN HyVee Inc 9cec2952-6f40-4352-8ffd-b46988b7df31 2026-03-18 Warnings Exact identifier application applno (ANDA): 214836 application number: ANDA214836 good sense dual action ACETAMINOPHEN, IBUPROFEN Sportpharm LLC 3f4ade2c-56e0-4aab-910e-73c26546a4d7 2026-02-06 Warnings Exact identifier application applno (ANDA): 214836 application number: ANDA214836 Motrin Dual Action With Tylenol ACETAMINOPHEN AND IBUPROFEN Kenvue Brands LLC f2ee9cf5-02b7-6612-e053-2995a90a90c4 2026-02-03 Warnings Exact identifier application applno (ANDA): 214836 application number: ANDA214836 ndc (product): 50580-208 equate dual pain reliever ACETAMINOPHEN, IBUPROFEN WALMART INC. 09dc976b-6065-4aad-9d57-0fe5e88a722a 2025-12-15 Warnings Exact identifier application applno (ANDA): 214836 application number: ANDA214836 CAREONE DUAL ACTION ACETAMINOPHEN, IBUPROFEN Retail Business Services, LLC 76302cb3-0371-49ce-85d8-5f3785c370b0 2025-08-25 Warnings Exact identifier application applno (ANDA): 214836 application number: ANDA214836 Dual Back Pain Reliever ACETAMINOPHEN, IBUPROFEN Walgreen Company 9831f374-658a-47ec-8a7e-4ff8359570be 2025-07-16 Warnings Exact identifier application applno (ANDA): 214836 application number: ANDA214836 dg health dual back pain reliever ACETAMINOPHEN, IBUPROFEN Dolgencorp Inc b52cfead-1cff-4e11-9953-f470fb785c73 2025-07-07 Warnings Exact identifier application applno (ANDA): 214836 application number: ANDA214836
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50580-208-02 50580020802 1 BOTTLE in 1 CARTON (50580-208-02) / 20 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2023-03-20 No No Current 50580-208-08 50580020808 1 BOTTLE in 1 CARTON (50580-208-08) / 80 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2023-03-20 No No Current 50580-208-12 50580020812 1 BOTTLE in 1 CARTON (50580-208-12) / 120 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2023-03-20 No No Current 50580-208-16 50580020816 2 CARTON in 1 CARTON (50580-208-16) / 1 BOTTLE in 1 CARTON / 80 TABLET, FILM COATED in 1 BOTTLE 2 carton 2024-04-01 No No Current