Home DailyMed 68bfdb02-41e9-4ce8-9c3f-7d4c4b6b5f55 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2013-03-03
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 03:58:48
Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N203826-001 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 RLD, RS 2012-12-20 N203826-002 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 RLD, RS 2019-06-19 N203826-003 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 RLD, RS 2019-06-19 N203826-004 IMMPHENTIV PHENYLEPHRINE HYDROCHLORIDE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-03-09 N203826-005 IMMPHENTIV PHENYLEPHRINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-03-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N203826-004 11471400 2036-08-05 Drug product 2023-03-22 N203826-004 11213480 2036-09-26 Drug product 2023-03-22 N203826-004 12257342 2036-09-26 Drug product 2025-04-23 N203826-005 11471400 2036-08-05 Drug product 2023-03-22 N203826-005 11213480 2036-09-26 Drug product 2023-03-22 N203826-005 12257342 2036-09-26 Drug product 2025-04-23
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 5 · 177 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N203826-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 RLD, RS 2012-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203826-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 RLD, RS 2019-06-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203826-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 RLD, RS 2019-06-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203826-004 IMMPHENTIV 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-03-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203826-005 IMMPHENTIV 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-03-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 N203826-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 RLD, RS 2012-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203826-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 RLD, RS 2019-06-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203826-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 RLD, RS 2019-06-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203826-004 IMMPHENTIV 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-03-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203826-005 IMMPHENTIV 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-03-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203826-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 RLD, RS 2012-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203826-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 RLD, RS 2019-06-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203826-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 RLD, RS 2019-06-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203826-004 IMMPHENTIV 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-03-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203826-005 IMMPHENTIV 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-03-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203826-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 RLD, RS 2012-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203826-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 RLD, RS 2019-06-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203826-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 RLD, RS 2019-06-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203826-004 IMMPHENTIV 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-03-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203826-005 IMMPHENTIV 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-03-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203826-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 RLD, RS 2012-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203826-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-06-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203826-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-06-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203826-004 IMMPHENTIV 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-03-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203826-005 IMMPHENTIV 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-03-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203826-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 RLD, RS 2012-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203826-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-06-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203826-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-06-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203826-004 IMMPHENTIV 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-03-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203826-005 IMMPHENTIV 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-03-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203826-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 RLD, RS 2012-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203826-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-06-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203826-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-06-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203826-004 IMMPHENTIV 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-03-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203826-005 IMMPHENTIV 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-03-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203826-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 RLD, RS 2012-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203826-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-06-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203826-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-06-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203826-004 IMMPHENTIV 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-03-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203826-005 IMMPHENTIV 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-03-09 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 91 observed states.
Observed Orange Book patent history# Patent history page 1 of 3 · 112 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N203826-004 11471400 2036-08-05 Drug product 2023-03-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203826-004 11213480 2036-09-26 Drug product 2023-03-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203826-004 12257342 2036-09-26 Drug product 2025-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203826-005 11471400 2036-08-05 Drug product 2023-03-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203826-005 11213480 2036-09-26 Drug product 2023-03-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203826-005 12257342 2036-09-26 Drug product 2025-04-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 N203826-004 11471400 2036-08-05 Drug product 2023-03-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203826-004 11213480 2036-09-26 Drug product 2023-03-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203826-004 12257342 2036-09-26 Drug product 2025-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203826-005 11471400 2036-08-05 Drug product 2023-03-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203826-005 11213480 2036-09-26 Drug product 2023-03-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203826-005 12257342 2036-09-26 Drug product 2025-04-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203826-004 11471400 2036-08-05 Drug product 2023-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203826-004 11213480 2036-09-26 Drug product 2023-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203826-004 12257342 2036-09-26 Drug product 2025-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203826-005 11471400 2036-08-05 Drug product 2023-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203826-005 11213480 2036-09-26 Drug product 2023-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203826-005 12257342 2036-09-26 Drug product 2025-04-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203826-004 11471400 2036-08-05 Drug product 2023-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203826-004 11213480 2036-09-26 Drug product 2023-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203826-004 12257342 2036-09-26 Drug product 2025-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203826-005 11471400 2036-08-05 Drug product 2023-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203826-005 11213480 2036-09-26 Drug product 2023-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203826-005 12257342 2036-09-26 Drug product 2025-04-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203826-004 11471400 2036-08-05 Drug product 2023-03-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203826-004 11213480 2036-09-26 Drug product 2023-03-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203826-004 12257342 2036-09-26 Drug product 2025-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203826-005 11471400 2036-08-05 Drug product 2023-03-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203826-005 11213480 2036-09-26 Drug product 2023-03-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203826-005 12257342 2036-09-26 Drug product 2025-04-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203826-004 11471400 2036-08-05 Drug product 2023-03-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203826-004 11213480 2036-09-26 Drug product 2023-03-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203826-005 11471400 2036-08-05 Drug product 2023-03-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203826-005 11213480 2036-09-26 Drug product 2023-03-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203826-004 11471400 2036-08-05 Drug product 2023-03-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203826-004 11213480 2036-09-26 Drug product 2023-03-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203826-005 11471400 2036-08-05 Drug product 2023-03-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203826-005 11213480 2036-09-26 Drug product 2023-03-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203826-004 11471400 2036-08-05 Drug product 2023-03-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203826-004 11213480 2036-09-26 Drug product 2023-03-22 03ed91905a0d…
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.