Phenylephrine Hydrochloride

Product NDC
17478-206
11-digit product format
174780206
Labeler code
17478
Product ID
17478-206_2ad7940b-ea2c-46d2-86ae-bbf382cae5a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenylephrine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Akorn
Application
NDA207926
Marketing category
NDA
Marketing start
2015-01-15
Marketing end
0000-00-00
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
100 mg/mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct17478-206DDiscontinued by firm2026-08-10
excluded packagepackage17478-20617478-206-05DDiscontinued by firm2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 22 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17478-206-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17478-206-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17478-206-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17478-206-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage17478-206-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage17478-206-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17478-206-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17478-206-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17478-206-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage17478-206-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage17478-206-05367a005e9d99…383a685ebd0f…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N207926-001PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE2.5%SOLUTION/DROPS / OPHTHALMICATRLD2015-01-15
N207926-002PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE10%SOLUTION/DROPS / OPHTHALMICATRLD2015-01-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N207926-001AT
N207926-002AT

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N207926-001PHENYLEPHRINE HYDROCHLORIDE2.5%SOLUTION/DROPS / OPHTHALMICATRLD2015-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207926-002PHENYLEPHRINE HYDROCHLORIDE10%SOLUTION/DROPS / OPHTHALMICATRLD2015-01-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207926-001PHENYLEPHRINE HYDROCHLORIDE2.5%SOLUTION/DROPS / OPHTHALMICATRLD2015-01-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207926-002PHENYLEPHRINE HYDROCHLORIDE10%SOLUTION/DROPS / OPHTHALMICATRLD2015-01-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08N207926-001PHENYLEPHRINE HYDROCHLORIDE2.5%SOLUTION/DROPS / OPHTHALMICATRLD2015-01-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207926-002PHENYLEPHRINE HYDROCHLORIDE10%SOLUTION/DROPS / OPHTHALMICATRLD2015-01-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207926-001PHENYLEPHRINE HYDROCHLORIDE2.5%SOLUTION/DROPS / OPHTHALMICATRLD2015-01-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207926-002PHENYLEPHRINE HYDROCHLORIDE10%SOLUTION/DROPS / OPHTHALMICATRLD2015-01-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207926-001PHENYLEPHRINE HYDROCHLORIDE2.5%SOLUTION/DROPS / OPHTHALMICATRLD2015-01-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207926-002PHENYLEPHRINE HYDROCHLORIDE10%SOLUTION/DROPS / OPHTHALMICATRLD2015-01-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207926-001PHENYLEPHRINE HYDROCHLORIDE2.5%SOLUTION/DROPS / OPHTHALMICATRLD2015-01-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207926-002PHENYLEPHRINE HYDROCHLORIDE10%SOLUTION/DROPS / OPHTHALMICATRLD2015-01-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207926-001PHENYLEPHRINE HYDROCHLORIDE2.5%SOLUTION/DROPS / OPHTHALMICATRLD2015-01-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207926-002PHENYLEPHRINE HYDROCHLORIDE10%SOLUTION/DROPS / OPHTHALMICATRLD2015-01-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207926-001PHENYLEPHRINE HYDROCHLORIDE2.5%SOLUTION/DROPS / OPHTHALMICATRLD2015-01-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207926-002PHENYLEPHRINE HYDROCHLORIDE10%SOLUTION/DROPS / OPHTHALMICATRLD2015-01-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207926-001PHENYLEPHRINE HYDROCHLORIDE2.5%SOLUTION/DROPS / OPHTHALMICATRLD2015-01-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207926-002PHENYLEPHRINE HYDROCHLORIDE10%SOLUTION/DROPS / OPHTHALMICATRLD2015-01-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N207926-001PHENYLEPHRINE HYDROCHLORIDE2.5%SOLUTION/DROPS / OPHTHALMICATRLD2015-01-15d06236e962d9…
2024-10-29 15:01 UTC2024-10N207926-002PHENYLEPHRINE HYDROCHLORIDE10%SOLUTION/DROPS / OPHTHALMICATRLD2015-01-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N207926-001PHENYLEPHRINE HYDROCHLORIDE2.5%SOLUTION/DROPS / OPHTHALMICATRLD2015-01-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N207926-002PHENYLEPHRINE HYDROCHLORIDE10%SOLUTION/DROPS / OPHTHALMICATRLD2015-01-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N207926-001PHENYLEPHRINE HYDROCHLORIDE2.5%SOLUTION/DROPS / OPHTHALMICATRLD2015-01-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N207926-002PHENYLEPHRINE HYDROCHLORIDE10%SOLUTION/DROPS / OPHTHALMICATRLD2015-01-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N207926-001PHENYLEPHRINE HYDROCHLORIDE2.5%SOLUTION/DROPS / OPHTHALMICATRLD2015-01-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N207926-002PHENYLEPHRINE HYDROCHLORIDE10%SOLUTION/DROPS / OPHTHALMICATRLD2015-01-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05N207926-001PHENYLEPHRINE HYDROCHLORIDE2.5%SOLUTION/DROPS / OPHTHALMICATRLD2015-01-158072bd15b7f6…
2024-05-31 18:47 UTC2024-05N207926-002PHENYLEPHRINE HYDROCHLORIDE10%SOLUTION/DROPS / OPHTHALMICATRLD2015-01-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207926-001PHENYLEPHRINE HYDROCHLORIDE2.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2015-01-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207926-002PHENYLEPHRINE HYDROCHLORIDE10%SOLUTION/DROPS / OPHTHALMICATRLD, RS2015-01-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N207926-001PHENYLEPHRINE HYDROCHLORIDE2.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2015-01-155d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N207926-002PHENYLEPHRINE HYDROCHLORIDE10%SOLUTION/DROPS / OPHTHALMICATRLD, RS2015-01-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N207926-001PHENYLEPHRINE HYDROCHLORIDE2.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2015-01-154b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N207926-002PHENYLEPHRINE HYDROCHLORIDE10%SOLUTION/DROPS / OPHTHALMICATRLD, RS2015-01-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N207926-001PHENYLEPHRINE HYDROCHLORIDE2.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2015-01-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N207926-002PHENYLEPHRINE HYDROCHLORIDE10%SOLUTION/DROPS / OPHTHALMICATRLD, RS2015-01-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N207926-001PHENYLEPHRINE HYDROCHLORIDE2.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2015-01-15bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N207926-002PHENYLEPHRINE HYDROCHLORIDE10%SOLUTION/DROPS / OPHTHALMICATRLD, RS2015-01-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N207926-001PHENYLEPHRINE HYDROCHLORIDE2.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2015-01-15782e0a99824c…
2021-12-28 21:50 UTC2021-12N207926-002PHENYLEPHRINE HYDROCHLORIDE10%SOLUTION/DROPS / OPHTHALMICATRLD, RS2015-01-15782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N207926-001AT1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207926-002AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207926-001AT131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207926-002AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08N207926-001AT16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207926-002AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207926-001AT1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207926-002AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207926-001AT1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207926-002AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207926-001AT103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207926-002AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207926-001AT12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207926-002AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207926-001AT15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207926-002AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207926-001AT1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207926-002AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N207926-001AT1d06236e962d9…
2024-10-29 15:01 UTC2024-10N207926-002AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N207926-001AT179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N207926-002AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N207926-001AT1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N207926-002AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N207926-001AT11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N207926-002AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N207926-001AT18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N207926-002AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207926-001AT15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207926-002AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N207926-001AT15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N207926-002AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N207926-001AT14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N207926-002AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N207926-001AT174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N207926-002AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N207926-001AT1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N207926-002AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N207926-001AT1782e0a99824c…
2021-12-28 21:50 UTC2021-12N207926-002AT1782e0a99824c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-206-05ML - Milliliter17478-20690c2c1d7-11d2-4fab-9644-cf12f33da4b712015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJPHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [AKORN, INC.]3
PhenylephrineACTIVE MOIETY1WS297W6MVPHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [AKORN, INC.]3
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7PHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [AKORN, INC.]3
Phosphoric AcidINACTIVE INGREDIENTE4GA8884NNPHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [AKORN, INC.]3
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IPHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [AKORN, INC.]3
Sodium Phosphate, Dibasic, AnhydrousINACTIVE INGREDIENT22ADO53M6FPHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [AKORN, INC.]3
Sodium Phosphate, Monobasic, AnhydrousINACTIVE INGREDIENTKH7I04HPUUPHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [AKORN, INC.]3
WaterINACTIVE INGREDIENT059QF0KO0RPHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [AKORN, INC.]3

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
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDEAlcon Laboratories, Inc.cacbb3fd-1c03-4523-a1bf-0ccc4be102ef2025-04-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 207926
application number: NDA207926

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17478-206-05174780206051 BOTTLE, DROPPER in 1 CARTON (17478-206-05) > 5 mL in 1 BOTTLE, DROPPER2015-01-150000-00-00NoNoCurrent