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 2 of 6 · 108 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
nasalPHENYLEPHRINE HYDROCHLORIDEKroger Company1c3dc4e6-452b-4c84-b53c-426cf9ae8f032026-02-12WarningsName fallback
generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDEMethod Pharmaceuticals, LLC4bab505d-d5c8-8c3b-e063-6394a90ad18a2026-02-01Warnings, Adverse reactionsName fallback
brand name: Phenylephrine Hydrochloride
generic name: PHENYLEPHRINE HYDROCHLORIDE
phenylephrine hydrochloridePHENYLEPHRINE HYDROCHLORIDEBaxter Healthcare Corporation74192a42-0ff7-443b-9d8a-3096ef5c8e432026-01-21Warnings, Adverse reactionsName fallback
brand name: phenylephrine hydrochloride
generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDEEugia US LLCc2ba1b3e-94bc-494d-b0fe-4ab9dd61dddc2026-01-19Warnings, Adverse reactionsName fallback
brand name: Phenylephrine Hydrochloride
generic name: PHENYLEPHRINE HYDROCHLORIDE
Gencare-Nasal Decongestant PEPHENYLEPHRINE HYDROCHLORIDEPioneer Life Sciences, LLCad4d74a8-a762-4378-9016-f7c83421073e2025-12-26WarningsName fallback
generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine hydrochloridePHENYLEPHRINE HYDROCHLORIDEProPharma Distribution386663e8-f1f6-cf14-e063-6394a90a68df2025-12-18Warnings, Adverse reactionsName fallback
brand name: Phenylephrine hydrochloride
generic name: PHENYLEPHRINE HYDROCHLORIDE
PREPARATION HPHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC40fde50a-3cc0-4286-9b33-8f3912254c332025-12-18WarningsName fallback
generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDESOLA Pharmaceuticals, LLCbf264b20-6d00-495e-90c7-9172d4535ec72025-12-08Warnings, Adverse reactionsName fallback
brand name: Phenylephrine Hydrochloride
generic name: PHENYLEPHRINE HYDROCHLORIDE
Quality ChoicePHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATIONa12e2e66-d2f3-47a6-a915-a309ae828d272025-12-04WarningsName fallback
generic name: PHENYLEPHRINE HYDROCHLORIDE
QUALITY CHOICEPHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION14596551-dd82-46b3-8eb8-e69efaea105b2025-12-04WarningsName fallback
generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine hydrochloridePHENYLEPHRINE HYDROCHLORIDEProvepharm Inc.e1d3881f-fa9e-4d68-8ef0-9e03435fc2922025-11-24Warnings, Adverse reactionsName fallback
brand name: Phenylephrine hydrochloride
generic name: PHENYLEPHRINE HYDROCHLORIDE
4 Way Fast ActingPHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLCa8fc41c7-4425-41b8-b1c6-eb22ac0547342025-11-12WarningsName fallback
generic name: PHENYLEPHRINE HYDROCHLORIDE
ValuMeds Nasal Decongestant Phenylephrine HClPHENYLEPHRINE HYDROCHLORIDECabinet Health P.B.C.21676b0c-6be2-464c-ae91-92e5f0d0087d2025-11-06WarningsName fallback
generic name: PHENYLEPHRINE HYDROCHLORIDE
phenylephrine hydrochloridePHENYLEPHRINE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.f454c289-5a31-4bd3-86a2-1281bf1ab14b2025-10-31Warnings, Adverse reactionsName fallback
brand name: phenylephrine hydrochloride
generic name: PHENYLEPHRINE HYDROCHLORIDE
Better LivingPHENYLEPHRINE HYDROCHLORIDEBETTER LIVING BRANDS LLCaea0db7f-e01a-4d8e-9c20-4a5ef4a905d12025-10-29WarningsName fallback
generic name: PHENYLEPHRINE HYDROCHLORIDE
PublixPHENYLEPHRINE HYDROCHLORIDEPUBLIX SUPER MARKETS, INCf10e120d-f0b7-4c51-b29b-e8cdbb1456f32025-10-28WarningsName fallback
generic name: PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEMedical Purchasing Solutions, LLC.41eec9e9-6e94-15d4-e063-6394a90a98a22025-10-24Warnings, Adverse reactionsName fallback
brand name: PHENYLEPHRINE HYDROCHLORIDE
generic name: PHENYLEPHRINE HYDROCHLORIDE
Extra Strength Sinus Relief Nasal DecongestantPHENYLEPHRINE HYDROCHLORIDECARDINAL HEALTH0d8a009c-30b5-4f12-90bd-f8aa1110243f2025-10-14WarningsName fallback
generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDEInvaTech Pharma Solutions LLCb8d360fa-0d80-f6a8-e053-2a95a90a8bd42025-10-01Name fallback
brand name: Phenylephrine Hydrochloride
generic name: PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEGland Pharma Limited2ba80bb2-24f3-4bce-bc04-a6ff4c54fefb2025-09-18Warnings, Adverse reactionsName fallback
brand name: PHENYLEPHRINE HYDROCHLORIDE
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