Home NDC 55111-565 Ibuprofen and Diphenhydramine Citrate
Product NDC 55111-565
11-digit product format 551110565
Labeler code 55111
Product ID 55111-565_d2953b94-9244-2c86-ac0c-7610dd1e7963
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen and Diphenhydramine Citrate
Dosage form TABLET
Route ORAL
Labeler Dr. Reddy's Laboratories Limited
Application ANDA090619
Marketing category ANDA
Marketing start 2010-01-31
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 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 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE DIPHENHYDRAMINE CITRATE; IBUPROFEN 38MG;200MG TABLET / ORAL 2009-07-08
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 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090619-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2009-07-08 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 Ibuprofen and Diphenhydramine Citrate
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 895664 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 55111-565-05 Ibuprofen and Diphenhydramine Citrate 500 in 1 BOTTLE TABLET 500 3 55111-565-05 Ibuprofen and Diphenhydramine Citrate 1 in 1 CARTON TABLET 1 3 55111-565-14 Ibuprofen and Diphenhydramine Citrate 1 in 1 CARTON TABLET 1 3 55111-565-14 Ibuprofen and Diphenhydramine Citrate 20 in 1 BOTTLE TABLET 20 3 55111-565-18 Ibuprofen and Diphenhydramine Citrate 180 in 1 BOTTLE TABLET 180 3 55111-565-18 Ibuprofen and Diphenhydramine Citrate 1 in 1 CARTON TABLET 1 3 55111-565-30 Ibuprofen and Diphenhydramine Citrate 1 in 1 CARTON TABLET 1 3 55111-565-30 Ibuprofen and Diphenhydramine Citrate 30 in 1 BOTTLE TABLET 30 3 55111-565-40 Ibuprofen and Diphenhydramine Citrate 40 in 1 BOTTLE TABLET 40 3 55111-565-40 Ibuprofen and Diphenhydramine Citrate 1 in 1 CARTON TABLET 1 3 55111-565-80 Ibuprofen and Diphenhydramine Citrate 1 in 1 CARTON TABLET 1 3 55111-565-80 Ibuprofen and Diphenhydramine Citrate 80 in 1 BOTTLE TABLET 80 3 55111-565-90 Ibuprofen and Diphenhydramine Citrate 1 in 1 CARTON TABLET 1 3 55111-565-90 Ibuprofen and Diphenhydramine Citrate 90 in 1 BOTTLE TABLET 90 3 55111-565-92 Ibuprofen and Diphenhydramine Citrate 2500 in 1 POUCH TABLET 2500 3
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55111-565 IBUPROFEN AND DIPHENHYDRAMINE CITRATE TABLET [DR. REDDY'S LABORATORIES LIMITED] 3 Current NDC, Legacy NDC, 15 package rows 20190312_42c06daf-541a-7721-b875-ea18364501a4.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 · 1 matching rows.
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 55111-565-05 55111056505 1 BOTTLE in 1 CARTON (55111-565-05) / 500 TABLET in 1 BOTTLE 1 bottle 2010-01-31 0000-00-00 No No Current 55111-565-14 55111056514 1 BOTTLE in 1 CARTON (55111-565-14) / 20 TABLET in 1 BOTTLE 1 bottle 2010-01-31 0000-00-00 No No Current 55111-565-18 55111056518 1 BOTTLE in 1 CARTON (55111-565-18) / 180 TABLET in 1 BOTTLE 1 bottle 2010-01-31 0000-00-00 No No Current 55111-565-30 55111056530 1 BOTTLE in 1 CARTON (55111-565-30) / 30 TABLET in 1 BOTTLE 1 bottle 2010-01-31 0000-00-00 No No Current 55111-565-40 55111056540 1 BOTTLE in 1 CARTON (55111-565-40) / 40 TABLET in 1 BOTTLE 1 bottle 2010-01-31 0000-00-00 No No Current 55111-565-80 55111056580 1 BOTTLE in 1 CARTON (55111-565-80) / 80 TABLET in 1 BOTTLE 1 bottle 2010-01-31 0000-00-00 No No Current 55111-565-90 55111056590 1 BOTTLE in 1 CARTON (55111-565-90) / 90 TABLET in 1 BOTTLE 1 bottle 2010-01-31 0000-00-00 No No Current 55111-565-92 55111056592 2500 TABLET in 1 POUCH (55111-565-92) 2500 tablet 2010-01-31 0000-00-00 No No Current