FDA.reportPublic FDA data

Application 213237

Type
ANDA
Sponsor
ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDESOLUTION;INTRAVENOUS10MG/ML (10MG/ML)NoNo
002PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDESOLUTION;INTRAVENOUS50MG/5ML (10MG/ML)NoNo
003PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDESOLUTION;INTRAVENOUS100MG/10ML (10MG/ML)NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213237-001PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01
A213237-002PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01
A213237-003PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01

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 3 · 117 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A213237-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-0184e616aacf4f…
2026-09-14 22:38:342026-08A213237-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-0184e616aacf4f…
2026-09-14 22:38:342026-08A213237-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-0184e616aacf4f…
2026-08-18 06:07:402026-07A213237-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A213237-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A213237-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213237-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213237-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213237-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213237-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213237-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213237-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213237-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213237-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213237-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213237-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213237-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213237-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213237-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213237-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213237-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213237-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213237-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213237-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213237-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213237-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213237-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213237-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213237-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213237-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213237-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213237-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213237-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213237-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A213237-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A213237-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213237-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213237-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213237-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213237-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 57 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-05-31 18:47 UTC2024-05A213237-001AP118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213237-002AP118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213237-003AP118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213237-001AP115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213237-002AP115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213237-003AP115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213237-001AP115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213237-002AP115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213237-003AP115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213237-001AP114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A213237-002AP114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A213237-003AP114b0b4de00fa7…
2020-12-22 03:56 UTC2020-12A213237-001AP118869cabd3fbd…
2020-12-22 03:56 UTC2020-12A213237-002AP118869cabd3fbd…
2020-12-22 03:56 UTC2020-12A213237-003AP118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A213237-001AP11c0c555d07b60…
2020-11-12 02:37 UTC2020-11A213237-002AP11c0c555d07b60…
2020-11-12 02:37 UTC2020-11A213237-003AP11c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213237-001AP116a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213237-002AP116a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213237-003AP116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213237-001AP111c564ffb4f44…
2024-02-18 07:12 UTC2024-02A213237-002AP111c564ffb4f44…
2024-02-18 07:12 UTC2024-02A213237-003AP111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213237-001AP11ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A213237-002AP11ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A213237-003AP11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213237-001AP11a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213237-002AP11a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213237-003AP11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213237-001AP119b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213237-002AP119b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213237-003AP119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213237-001AP11a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213237-002AP11a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213237-003AP11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213237-001AP113f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213237-002AP113f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213237-003AP113f0d92c62455…
2023-05-13 08:27 UTC2023-05A213237-001AP11053a50430f4f…

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 3 of 6 · 108 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medi-First Sinus DecongestantPHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporation9654f5cd-74d7-44a2-9674-666d1e94ffa72025-09-08WarningsName fallback
generic name: PHENYLEPHRINE HYDROCHLORIDE
Green Guard Allergy 2 ReliefPHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporation16fddca9-a66b-41e6-9423-eaf091d3971e2025-09-08WarningsName fallback
generic name: PHENYLEPHRINE HYDROCHLORIDE
Medique Medi-PhenylPHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporationd7d62ac1-1333-4366-884b-26537766ce382025-09-08WarningsName fallback
generic name: PHENYLEPHRINE HYDROCHLORIDE
Crane Safety Sinus DecongestantPHENYLEPHRINE HYDROCHLORIDECrane Safety LLC968baa85-ce0e-0c3d-e053-2995a90ac03a2025-09-08WarningsName fallback
generic name: PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEDr.Reddy's Laboratories Inc.,869917f1-ae26-40cd-d332-5a31a796b8772025-08-31Warnings, Adverse reactionsName fallback
brand name: PHENYLEPHRINE HYDROCHLORIDE
generic name: PHENYLEPHRINE HYDROCHLORIDE
ReVIVOL-XRPHENYLEPHRINE HYDROCHLORIDEUnipack LLC2950fe83-a2a4-4ed4-b645-69d6fd2381ae2025-07-13WarningsName fallback
generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDEFresenius Kabi USA, LLCb54a0c59-e5e4-4fd7-ba91-c991ce87b1482025-07-04Warnings, Adverse reactionsName fallback
brand name: Phenylephrine Hydrochloride
generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDEHenry Schein, Inc.db313f72-a6bb-444f-949f-19b4aa6f61c02025-06-18Warnings, Adverse reactionsName fallback
brand name: Phenylephrine Hydrochloride
generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDEFresenius Kabi USA, LLC1e77b9c8-fa17-4aa4-adc8-ff716ab2e5d72025-05-15Warnings, Adverse reactionsName fallback
brand name: Phenylephrine Hydrochloride
generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine hydrochloridePHENYLEPHRINE HYDROCHLORIDEAmneal Pharmaceuticals LLCfad93be4-32dd-44c1-a20f-2b0bb3b419292025-05-01Warnings, Adverse reactionsName fallback
brand name: Phenylephrine hydrochloride
generic name: PHENYLEPHRINE HYDROCHLORIDE
PREPARATION HPHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC96d2e0e7-2de0-4660-9ffd-9edb2ad224d82025-04-18WarningsName fallback
generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDEAlcon Laboratories, Inc.cacbb3fd-1c03-4523-a1bf-0ccc4be102ef2025-04-01Warnings, Adverse reactionsName fallback
brand name: Phenylephrine Hydrochloride
generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDESomerset Therapeutics, LLC170e63f1-23f4-4839-ab89-b81832d94a562025-03-05Warnings, Adverse reactionsName fallback
brand name: Phenylephrine Hydrochloride
generic name: PHENYLEPHRINE HYDROCHLORIDE
Nasal Decongestant PEPHENYLEPHRINE HYDROCHLORIDEBi-Martd208cb6f-e142-4aa3-959b-e6b601df76c12025-03-01WarningsName fallback
generic name: PHENYLEPHRINE HYDROCHLORIDE
Gencare-Nasal Decongestant PEPHENYLEPHRINE HYDROCHLORIDEPioneer Life Sciences, LLC596ec923-56a0-4b6e-a69c-8d740feb75a22025-02-20WarningsName fallback
generic name: PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDECaplin Steriles Limited1b3eec91-5be5-4010-bf92-4c3e72b39b2a2025-01-23Warnings, Adverse reactionsName fallback
brand name: PHENYLEPHRINE HYDROCHLORIDE
generic name: PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEMedical Purchasing Solutions, LLC4099cef4-44b1-ae3d-e063-6394a90aefac2025-01-20Warnings, Adverse reactionsName fallback
brand name: PHENYLEPHRINE HYDROCHLORIDE
generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDECivica, Inc.7a23ed28-3912-4398-b660-bf9ec3ee39262024-12-26Warnings, Adverse reactionsName fallback
brand name: Phenylephrine Hydrochloride
generic name: PHENYLEPHRINE HYDROCHLORIDE
good neighbor pharmacy nasal fourPHENYLEPHRINE HYDROCHLORIDEAmerisource Bergena3d637dc-d957-458c-8a75-f948601a31aa2024-11-14WarningsName fallback
generic name: PHENYLEPHRINE HYDROCHLORIDE
Sudafed PE Sinus CongestionPHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC2ca08917-1a75-4365-8520-c083e6a4225a2024-11-08WarningsName fallback
generic name: PHENYLEPHRINE HYDROCHLORIDE

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16729-464Phenylephrine hydrochloridePhenylephrine hydrochlorideAccord Healthcare, Inc.ANDACurrent
16729-465Phenylephrine hydrochloridePhenylephrine hydrochlorideAccord Healthcare, Inc.ANDACurrent
16729-466Phenylephrine hydrochloridePhenylephrine hydrochlorideAccord Healthcare, Inc.ANDACurrent