Home NDC 50580-563 Motrin
Product NDC 50580-563
11-digit product format 505800563
Labeler code 50580
Product ID 50580-563_39a34ab2-9fae-444e-e063-6294a90a9152
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen and Diphenhydramine Citrate
Dosage form TABLET, COATED
Route ORAL
Labeler Kenvue Brands LLC
Application ANDA079113
Marketing category ANDA
Marketing start 2010-01-11
Substance IBUPROFEN; DIPHENHYDRAMINE CITRATE
Active strength 200; 38 mg/1; mg/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE DIPHENHYDRAMINE CITRATE; IBUPROFEN 38MG;200MG TABLET / ORAL 2008-12-22
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.
Product history page 1 of 2 · 43 observed 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 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 f41ea6bd6efb…
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
Brand name suffix PM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 200 mg/1 DIPHENHYDRAMINE CITRATE 38 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 4OD433S209 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 895664 Internal RxNorm lookup 895666 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 50580-563-20 MotrinPM 1 in 1 CARTON TABLET, COATED 1 12 50580-563-20 MotrinPM 20 in 1 BOTTLE, PLASTIC TABLET, COATED 20 12 50580-563-40 MotrinPM 40 in 1 BOTTLE, PLASTIC TABLET, COATED 40 12 50580-563-40 MotrinPM 1 in 1 CARTON TABLET, COATED 1 12 50580-563-80 MotrinPM 80 in 1 BOTTLE, PLASTIC TABLET, COATED 80 12 50580-563-80 MotrinPM 1 in 1 CARTON TABLET, COATED 1 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Diphenhydramine Citrate ACTIVE INGREDIENT 4OD433S209 MOTRIN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 2 Ibuprofen ACTIVE INGREDIENT WK2XYI10QM MOTRIN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 2 Diphenhydramine ACTIVE MOIETY 8GTS82S83M MOTRIN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 2 Ibuprofen ACTIVE MOIETY WK2XYI10QM MOTRIN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 2 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U MOTRIN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 2 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 MOTRIN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 2 glyceryl dibehenate INACTIVE INGREDIENT R8WTH25YS2 MOTRIN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 2 hydroxypropyl cellulose (Type E) INACTIVE INGREDIENT 66O7AQV0RT MOTRIN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 2 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X MOTRIN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 2 magnesium stearate INACTIVE INGREDIENT 70097M6I30 MOTRIN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 2 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A MOTRIN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 2 polyvinyl alcohol INACTIVE INGREDIENT 532B59J990 MOTRIN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 2 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 MOTRIN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 2 talc INACTIVE INGREDIENT 7SEV7J4R1U MOTRIN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 2 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP MOTRIN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-563 MOTRIN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [KENVUE BRANDS LLC] 11 Current NDC, Legacy NDC, 6 package rows 20241109_55403f19-58ae-450b-8a7b-0bc544088f20.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 2 of 2 · 21 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50580-563-20 50580056320 1 BOTTLE, PLASTIC in 1 CARTON (50580-563-20) / 20 TABLET, COATED in 1 BOTTLE, PLASTIC 2010-01-11 0000-00-00 No No Current 50580-563-40 50580056340 40 in 1 BOTTLE, PLASTIC Historical 50580-563-80 50580056380 1 BOTTLE, PLASTIC in 1 CARTON (50580-563-80) / 80 TABLET, COATED in 1 BOTTLE, PLASTIC 2010-01-11 0000-00-00 No No Current