FDA.reportPublic FDA data

Ibuprofen and Diphenhydramine Citrate

Product NDC
55111-565
Requested package NDC
55111-565-80
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATEDIPHENHYDRAMINE CITRATE; IBUPROFEN38MG;200MGTABLET / ORAL2009-07-08

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-0884e616aacf4f…
2026-08-18 06:07:402026-07A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-083f01610625f2…
2019-09-15 20:21 UTC2019-09A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090619-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2009-07-08f41ea6bd6efb…

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
IngredientStrength
IBUPROFEN200 mg/1
DIPHENHYDRAMINE CITRATE38 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WK2XYI10QMInternal UNII lookup
4OD433S209Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
895664Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
42c06daf-541a-7721-b875-ea18364501a4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-565-05Ibuprofen and Diphenhydramine Citrate500 in 1 BOTTLETABLET5003
55111-565-05Ibuprofen and Diphenhydramine Citrate1 in 1 CARTONTABLET13
55111-565-14Ibuprofen and Diphenhydramine Citrate1 in 1 CARTONTABLET13
55111-565-14Ibuprofen and Diphenhydramine Citrate20 in 1 BOTTLETABLET203
55111-565-18Ibuprofen and Diphenhydramine Citrate180 in 1 BOTTLETABLET1803
55111-565-18Ibuprofen and Diphenhydramine Citrate1 in 1 CARTONTABLET13
55111-565-30Ibuprofen and Diphenhydramine Citrate1 in 1 CARTONTABLET13
55111-565-30Ibuprofen and Diphenhydramine Citrate30 in 1 BOTTLETABLET303
55111-565-40Ibuprofen and Diphenhydramine Citrate40 in 1 BOTTLETABLET403
55111-565-40Ibuprofen and Diphenhydramine Citrate1 in 1 CARTONTABLET13
55111-565-80Ibuprofen and Diphenhydramine Citrate1 in 1 CARTONTABLET13
55111-565-80Ibuprofen and Diphenhydramine Citrate80 in 1 BOTTLETABLET803
55111-565-90Ibuprofen and Diphenhydramine Citrate1 in 1 CARTONTABLET13
55111-565-90Ibuprofen and Diphenhydramine Citrate90 in 1 BOTTLETABLET903
55111-565-92Ibuprofen and Diphenhydramine Citrate2500 in 1 POUCHTABLET25003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
diphenhydramine citrateACTIVE INGREDIENT4OD433S209IBUPROFEN AND DIPHENHYDRAMINE CITRATE TABLET [DR. REDDY'S LABORATORIES LIMITED]1
ibuprofenACTIVE INGREDIENTWK2XYI10QMIBUPROFEN AND DIPHENHYDRAMINE CITRATE TABLET [DR. REDDY'S LABORATORIES LIMITED]1
diphenhydramineACTIVE MOIETY8GTS82S83MIBUPROFEN AND DIPHENHYDRAMINE CITRATE TABLET [DR. REDDY'S LABORATORIES LIMITED]1
ibuprofenACTIVE MOIETYWK2XYI10QMIBUPROFEN AND DIPHENHYDRAMINE CITRATE TABLET [DR. REDDY'S LABORATORIES LIMITED]1
carnauba waxINACTIVE INGREDIENTR12CBM0EIZIBUPROFEN AND DIPHENHYDRAMINE CITRATE TABLET [DR. REDDY'S LABORATORIES LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN AND DIPHENHYDRAMINE CITRATE TABLET [DR. REDDY'S LABORATORIES LIMITED]1
colloidal silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN AND DIPHENHYDRAMINE CITRATE TABLET [DR. REDDY'S LABORATORIES LIMITED]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48IBUPROFEN AND DIPHENHYDRAMINE CITRATE TABLET [DR. REDDY'S LABORATORIES LIMITED]1
FD&C blue no. 2INACTIVE INGREDIENTL06K8R7DQKIBUPROFEN AND DIPHENHYDRAMINE CITRATE TABLET [DR. REDDY'S LABORATORIES LIMITED]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN AND DIPHENHYDRAMINE CITRATE TABLET [DR. REDDY'S LABORATORIES LIMITED]1
polydextroseINACTIVE INGREDIENTVH2XOU12IEIBUPROFEN AND DIPHENHYDRAMINE CITRATE TABLET [DR. REDDY'S LABORATORIES LIMITED]1
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQIBUPROFEN AND DIPHENHYDRAMINE CITRATE TABLET [DR. REDDY'S LABORATORIES LIMITED]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JIBUPROFEN AND DIPHENHYDRAMINE CITRATE TABLET [DR. REDDY'S LABORATORIES LIMITED]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN AND DIPHENHYDRAMINE CITRATE TABLET [DR. REDDY'S LABORATORIES LIMITED]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN AND DIPHENHYDRAMINE CITRATE TABLET [DR. REDDY'S LABORATORIES LIMITED]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN AND DIPHENHYDRAMINE CITRATE TABLET [DR. REDDY'S LABORATORIES LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-565IBUPROFEN AND DIPHENHYDRAMINE CITRATE TABLET [DR. REDDY'S LABORATORIES LIMITED]3Current NDC, Legacy NDC, 15 package rows20190312_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibuprofen and Diphenhydramine CitrateIBUPROFEN AND DIPHENHYDRAMINE CITRATEDr. Reddy's Laboratories Limited42c06daf-541a-7721-b875-ea18364501a42018-12-05WarningsExact identifier
application applno (ANDA): 090619
application number: ANDA090619
ndc (package): 55111-565-80
ndc (product): 55111-565
ndc11 (package): 55111056580

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895664ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral TabletPSN42c06daf-541a-7721-b875-ea18364501a43
895664diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral TabletSCD42c06daf-541a-7721-b875-ea18364501a43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-565-80551110565801 BOTTLE in 1 CARTON (55111-565-80) / 80 TABLET in 1 BOTTLE1 bottle2010-01-310000-00-00NoNoCurrent