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 1 of 6 · 108 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.e1a7ab4b-0afe-4463-a039-5be0323cf2f72026-08-19Warnings, Adverse reactionsName fallback
brand name: Phenylephrine Hydrochloride
generic name: PHENYLEPHRINE HYDROCHLORIDE
Extra Strength NasalPHENYLEPHRINE HYDROCHLORIDECVS PHARMACY7acf1a9a-bd97-48bb-8025-ac26070378a22026-08-18WarningsName fallback
generic name: PHENYLEPHRINE HYDROCHLORIDE
NASALPHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC02a89765-2a75-470a-9fd6-8cce71dc19e92026-08-10WarningsName fallback
generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDELifestar Pharma LLC1767c4b7-36a0-4e64-9091-2af22161402f2026-07-30Warnings, Adverse reactionsName fallback
brand name: Phenylephrine Hydrochloride
generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDELifestar Pharma LLCf43e4abd-0083-4fe5-9c27-0ba9245e51382026-07-30Warnings, Adverse reactionsName fallback
brand name: Phenylephrine Hydrochloride
generic name: PHENYLEPHRINE HYDROCHLORIDE
up and upPHENYLEPHRINE HYDROCHLORIDETarget Corporationb42775ae-44fe-487e-b9ca-21d9687020a92026-07-29WarningsName fallback
generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine hydrochloridePHENYLEPHRINE HYDROCHLORIDECardinal Health 107, LLC6d59ee85-08e5-452d-a09a-35fcc2a82b752026-07-21Warnings, Adverse reactionsName fallback
brand name: Phenylephrine hydrochloride
generic name: PHENYLEPHRINE HYDROCHLORIDE
ValuMeds Nasal Decongestant PE PhenylephrinePHENYLEPHRINE HYDROCHLORIDECabinet Health P.B.C.3f284420-87c1-4c17-99e5-bc569bf9d45f2026-07-10WarningsName fallback
generic name: PHENYLEPHRINE HYDROCHLORIDE
Neo-Synephrine SeverePHENYLEPHRINE HYDROCHLORIDEBF ASCHER AND CO INC54edaff7-d241-dc90-e063-6294a90ac64d2026-06-23WarningsName fallback
generic name: PHENYLEPHRINE HYDROCHLORIDE
NO DRIP NASALPHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED7a866cdf-1c0c-403a-afc8-0e99e0ce81aa2026-06-22WarningsName fallback
generic name: PHENYLEPHRINE HYDROCHLORIDE
GoodMeds Nasal DecongestantPHENYLEPHRINE HYDROCHLORIDECabinet Health P.B.C.6a8a961c-d2d2-428d-8af7-8527aae25c8a2026-06-19WarningsName fallback
generic name: PHENYLEPHRINE HYDROCHLORIDE
Equate NasalPHENYLEPHRINE HYDROCHLORIDEWALMART INC.30f6d588-ad80-4348-a45f-77337e067bca2026-06-19WarningsName fallback
generic name: PHENYLEPHRINE HYDROCHLORIDE
NasalPHENYLEPHRINE HYDROCHLORIDECVS Pharmacy694a3116-1b75-42cd-bbcf-d19831c2d7962026-06-01WarningsName fallback
generic name: PHENYLEPHRINE HYDROCHLORIDE
Nasal Decongestant PEPHENYLEPHRINE HYDROCHLORIDEHHH Pharmaceuticals90fae0fa-da07-4ea8-bdbd-39c2ed99ae592026-05-06WarningsName fallback
generic name: PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEHHH Pharmaceuticals5d8b980f-0011-41e3-a881-ad10fe3990792026-05-06WarningsName fallback
brand name: PHENYLEPHRINE HYDROCHLORIDE
generic name: PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDECaplin Steriles Limited1b9f1d54-ea46-49c8-a33e-c94a61bc04602026-04-28Warnings, Adverse reactionsName fallback
brand name: PHENYLEPHRINE HYDROCHLORIDE
generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine hydrochloridePHENYLEPHRINE HYDROCHLORIDEPar Health USA, LLCd92631a6-bae8-493b-b4df-c563346607a82026-04-13Warnings, Adverse reactionsName fallback
brand name: Phenylephrine hydrochloride
generic name: PHENYLEPHRINE HYDROCHLORIDE
Nasal FourPHENYLEPHRINE HYDROCHLORIDEHyVee Inc19879fc8-4962-4c6e-87ed-b874d1d564af2026-04-01WarningsName fallback
generic name: PHENYLEPHRINE HYDROCHLORIDE
BiorphenPHENYLEPHRINE HYDROCHLORIDEDr. Reddy's Laboratories Inc.2f715e4e-b269-b935-d2c9-003cb29770be2026-03-31Warnings, Adverse reactionsName fallback
generic name: PHENYLEPHRINE HYDROCHLORIDE
Medi-First Plus Sinus DecongestantPHENYLEPHRINE HYDROCHLORIDESportpharm LLC20f58b0b-c123-477f-a62c-fa5423e23f932026-03-06WarningsName 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