FDA.reportPublic FDA data

Application 074567

Type
ANDA
Sponsor
OHM LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROHM COLD AND SINUSIBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDETABLET;ORAL200MG;30MGNoNo

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
A074567-001IBUPROHM COLD AND SINUSIBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2001-04-17

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 22:38:342026-08A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-1784e616aacf4f…
2026-08-18 06:07:402026-07A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-173f01610625f2…
2019-09-15 20:21 UTC2019-09A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17f41ea6bd6efb…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDERite-Aid483c3bb7-529e-4684-80e1-6646b050988e2026-07-31WarningsExact identifier
application applno (ANDA): 074567
application number: ANDA074567
ndc (product): 11822-0084
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEPublix Super Markets Inc2b98a62b-bd92-4fb8-ad0f-521cb477b6122026-07-31WarningsExact identifier
application applno (ANDA): 074567
application number: ANDA074567
ndc (product): 56062-423
Ibuprofen and Pseudoephedrine hydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEOhm Laboratories Inc.65ec0f85-7ca3-4adc-b152-a0ae2fd0692f2025-02-27WarningsExact identifier
application applno (ANDA): 074567
application number: ANDA074567
ndc (product): 51660-423
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEStrategic Sourcing Services LLCd93ae778-e6e9-4d1d-8f46-c04d962a93932024-11-22WarningsExact identifier
application applno (ANDA): 074567
application number: ANDA074567
ndc (product): 62011-0070

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideWALGREEN COMPANYANDACurrent
0363-0423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideWALGREEN COMPANYANDACurrent
0363-0423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideWALGREEN COMPANYANDACurrent
11673-423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideTarget CorporationANDACurrent
11822-0084Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideRite-AidANDACurrent
11822-0084Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideRite-AidANDACurrent
21130-423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideSafeway Inc.ANDACurrent
30142-423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideThe Kroger CompanyANDACurrent
30142-423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideThe Kroger CompanyANDACurrent
36800-423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideTopco Associates LLCANDACurrent
37808-324Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideHEBANDACurrent
37808-423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideHEBANDACurrent
41250-423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideMeijer Distribution, IncANDACurrent
46084-091IBUPROFEN COLD AND SINUSIBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEA P J Laboratories LimitedANDACurrent
49348-097Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideSunmarkANDACurrent
51660-423Ibuprofen and Pseudoephedrine hydrochlorideibuprofen and pseudoephedrine hydrochlorideOhm Laboratories Inc.ANDACurrent
51660-423Ibuprofen and Pseudoephedrine hydrochlorideibuprofen and pseudoephedrine hydrochlorideOhm Laboratories Inc.ANDACurrent
51660-490Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideOhm Laboratories Inc.ANDACurrent
51660-490Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideOhm Laboratories Inc.ANDACurrent
51660-493Ibuprofen and Pseudoephedrine hydrochlorideibuprofen and pseudoephedrine hydrochlorideOhm Laboratories Inc.ANDACurrent
51660-493Ibuprofen and Pseudoephedrine hydrochlorideibuprofen and pseudoephedrine hydrochlorideOhm Laboratories Inc.ANDACurrent
53943-423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideDiscount Drug MartANDACurrent
56062-423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochloridePublix Super Markets IncANDACurrent
59779-430Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideCVS PharmacyANDACurrent
59779-430Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideCVS PharmacyANDACurrent
62011-0070Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideStrategic Sourcing Services LLCANDACurrent
62011-0070Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideHealth MartANDACurrent
63629-5284Ibuprofen and Pseudoephedrine hydrochlorideibuprofen and pseudoephedrine hydrochlorideBryant Ranch PrepackANDACurrent
63629-5284Ibuprofen and Pseudoephedrine hydrochlorideibuprofen and pseudoephedrine hydrochlorideBryant Ranch PrepackANDACurrent
63868-453Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideChain Drug Marketing Association Inc.ANDACurrent
68016-423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideChain Drug Consortium, LLC.ANDACurrent
68258-8902Good Neighbor Pharmacy Ibuprofen Cold and SinusIbuprofen, Pseudoephedrine HydrochlorideDispensing Solutions, Inc.ANDACurrent
70000-0602IBUPROFEN and PSEUDOEPHEDRINE HYDROCHLORIDEIBUPROFEN and PSEUDOEPHEDRINE HYDROCHLORIDECARDINAL HEALTH 110, LLC DBA LEADERANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42854ORIG2005-07-22
8425ORIG2001-04-17