promethazine hydrochloride, phenylephrine hydrochloride and codeine phosphate

Product NDC: 50383-805
11-digit product format: 503830805
Labeler code: 50383
Product ID: 50383-805_9d5b76d0-633e-44f1-b1e1-63efab89626d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: promethazine hydrochloride, phenylephrine hydrochloride and codeine phosphate
Dosage form: SOLUTION
Route: ORAL
Labeler: Akorn
Application: ANDA040674
Marketing category: ANDA
Marketing start: 2015-06-16
Marketing end: 0000-00-00
Substance: CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
Active strength: 10 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS], alpha-1 Adrenergic Agonist [EPC]
DEA schedule: CV
NDC exclude flag: No
Listing certified through: 2024-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50383-805		D	Discontinued by firm	2026-10-05
excluded package	package	50383-805	50383-805-04	D	Discontinued by firm	2026-10-05
excluded package	package	50383-805	50383-805-16	D	Discontinued by firm	2026-10-05

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 · 33 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50383-805-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50383-805-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50383-805-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50383-805-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50383-805-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50383-805-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50383-805-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50383-805-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50383-805-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50383-805-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50383-805-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50383-805-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50383-805-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50383-805-16	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50383-805-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50383-805-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50383-805-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50383-805-16	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50383-805-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50383-805-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50383-805-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50383-805-16	`367a005e9d99…`	`383a685ebd0f…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL			2014-12-23

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL		2014-12-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL		2014-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL		2014-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL		2014-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL		2014-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL		2014-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL		2014-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL		2014-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL		2014-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL		2014-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL		2014-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL		2014-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL		2014-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL		2014-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL		2014-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL		2014-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2014-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2014-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2014-12-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2014-12-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2014-12-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2014-12-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2014-12-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2014-12-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2014-12-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2014-12-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2014-12-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2014-12-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2014-12-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2014-12-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2014-12-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2014-12-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2014-12-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2014-12-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2014-12-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2014-12-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2014-12-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2014-12-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2014-12-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2014-12-23	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040674-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040674-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040674-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040674-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040674-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040674-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040674-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040674-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040674-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040674-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040674-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040674-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040674-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040674-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040674-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040674-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040674-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040674-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040674-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040674-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040674-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040674-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040674-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040674-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040674-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040674-001	AA	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50383-805-04	2025-12-17	These highlights do not include all the information needed to use PROMETHAZINE HCl, PHENYLEPHRINE HCl AND CODEINE PHOSPHATE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE HCl, PHENYLEPHRINE HCl AND CODEINE PHOSPHATE ORAL SOLUTION. PROMETHAZINE HCl, PHENYLEPHRINE HCl AND CODEINE PHOSPHATE oral solution, USP, CV Initial U.S. Approval: 1952
50383-805-16	2025-12-17	These highlights do not include all the information needed to use PROMETHAZINE HCl, PHENYLEPHRINE HCl AND CODEINE PHOSPHATE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE HCl, PHENYLEPHRINE HCl AND CODEINE PHOSPHATE ORAL SOLUTION. PROMETHAZINE HCl, PHENYLEPHRINE HCl AND CODEINE PHOSPHATE oral solution, USP, CV Initial U.S. Approval: 1952
50383-805-04	2024-07-30	These highlights do not include all the information needed to use PROMETHAZINE HCl, PHENYLEPHRINE HCl AND CODEINE PHOSPHATE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE HCl, PHENYLEPHRINE HCl AND CODEINE PHOSPHATE ORAL SOLUTION. PROMETHAZINE HCl, PHENYLEPHRINE HCl AND CODEINE PHOSPHATE oral solution, USP, CV Initial U.S. Approval: 1952
50383-805-16	2024-07-30	These highlights do not include all the information needed to use PROMETHAZINE HCl, PHENYLEPHRINE HCl AND CODEINE PHOSPHATE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE HCl, PHENYLEPHRINE HCl AND CODEINE PHOSPHATE ORAL SOLUTION. PROMETHAZINE HCl, PHENYLEPHRINE HCl AND CODEINE PHOSPHATE oral solution, USP, CV Initial U.S. Approval: 1952
50383-805-04	2024-01-30	These highlights do not include all the information needed to use PROMETHAZINE HCl, PHENYLEPHRINE HCl AND CODEINE PHOSPHATE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE HCl, PHENYLEPHRINE HCl AND CODEINE PHOSPHATE ORAL SOLUTION. PROMETHAZINE HCl, PHENYLEPHRINE HCl AND CODEINE PHOSPHATE oral solution, USP, CV Initial U.S. Approval: 1952
50383-805-16	2024-01-30	These highlights do not include all the information needed to use PROMETHAZINE HCl, PHENYLEPHRINE HCl AND CODEINE PHOSPHATE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE HCl, PHENYLEPHRINE HCl AND CODEINE PHOSPHATE ORAL SOLUTION. PROMETHAZINE HCl, PHENYLEPHRINE HCl AND CODEINE PHOSPHATE oral solution, USP, CV Initial U.S. Approval: 1952

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50383-805-04	ML - Milliliter	50383-805	85cc4215-4b40-4df4-be22-c1c04cb8a5f2	1	2015-09-10
50383-805-16	ML - Milliliter	50383-805	ba486851-c2da-420b-98ec-723aa0c99e0a	1	2015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, AND CODEINE PHOSPHATE (PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDOCHLORIDE, AND CODEINE PHOSPHATE) SYRUP [HI-TECH PHARMACAL CO., INC.]	3
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, AND CODEINE PHOSPHATE (PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDOCHLORIDE, AND CODEINE PHOSPHATE) SYRUP [HI-TECH PHARMACAL CO., INC.]	3
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, AND CODEINE PHOSPHATE (PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDOCHLORIDE, AND CODEINE PHOSPHATE) SYRUP [HI-TECH PHARMACAL CO., INC.]	3
CODEINE ANHYDROUS	ACTIVE MOIETY	UX6OWY2V7J	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, AND CODEINE PHOSPHATE (PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDOCHLORIDE, AND CODEINE PHOSPHATE) SYRUP [HI-TECH PHARMACAL CO., INC.]	3
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, AND CODEINE PHOSPHATE (PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDOCHLORIDE, AND CODEINE PHOSPHATE) SYRUP [HI-TECH PHARMACAL CO., INC.]	3
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, AND CODEINE PHOSPHATE (PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDOCHLORIDE, AND CODEINE PHOSPHATE) SYRUP [HI-TECH PHARMACAL CO., INC.]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, AND CODEINE PHOSPHATE (PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDOCHLORIDE, AND CODEINE PHOSPHATE) SYRUP [HI-TECH PHARMACAL CO., INC.]	3
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, AND CODEINE PHOSPHATE (PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDOCHLORIDE, AND CODEINE PHOSPHATE) SYRUP [HI-TECH PHARMACAL CO., INC.]	3
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, AND CODEINE PHOSPHATE (PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDOCHLORIDE, AND CODEINE PHOSPHATE) SYRUP [HI-TECH PHARMACAL CO., INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, AND CODEINE PHOSPHATE (PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDOCHLORIDE, AND CODEINE PHOSPHATE) SYRUP [HI-TECH PHARMACAL CO., INC.]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, AND CODEINE PHOSPHATE (PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDOCHLORIDE, AND CODEINE PHOSPHATE) SYRUP [HI-TECH PHARMACAL CO., INC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, AND CODEINE PHOSPHATE (PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDOCHLORIDE, AND CODEINE PHOSPHATE) SYRUP [HI-TECH PHARMACAL CO., INC.]	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, AND CODEINE PHOSPHATE (PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDOCHLORIDE, AND CODEINE PHOSPHATE) SYRUP [HI-TECH PHARMACAL CO., INC.]	3
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, AND CODEINE PHOSPHATE (PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDOCHLORIDE, AND CODEINE PHOSPHATE) SYRUP [HI-TECH PHARMACAL CO., INC.]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, AND CODEINE PHOSPHATE (PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDOCHLORIDE, AND CODEINE PHOSPHATE) SYRUP [HI-TECH PHARMACAL CO., INC.]	3
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, AND CODEINE PHOSPHATE (PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDOCHLORIDE, AND CODEINE PHOSPHATE) SYRUP [HI-TECH PHARMACAL CO., INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, AND CODEINE PHOSPHATE (PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDOCHLORIDE, AND CODEINE PHOSPHATE) SYRUP [HI-TECH PHARMACAL CO., INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50383-805	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE SOLUTION [AKORN]	18	Legacy NDC	20230112_3f40cef0-431c-4728-9a91-10720b16de55.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
GSL05Y1MN6	CODEINE PHOSPHATE	41444-62-6	CODEINE PHOSPHATE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE
R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE	58-33-3	PROMETHAZINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50383-805-04	50383080504	118 mL in 1 BOTTLE (50383-805-04)	118 ml	2016-06-06	0000-00-00	No	No	Current
50383-805-16	50383080516	473 mL in 1 BOTTLE (50383-805-16)	473 ml	2016-06-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
promethazine hydrochloride, phenylephrine hydrochloride and codeine phosphate	Akorn \| Akorn Operating Company LLC	2023-01-11	HUMAN PRESCRIPTION DRUG LABEL	18