Promethazine VC

Product NDC: 68788-9100
11-digit product format: 687889100
Labeler code: 68788
Product ID: 68788-9100_b00b296d-6c34-48c8-9cfb-71ccc5c9a908
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Promethazinehydrochloride and phenylephrine hydrochloride
Dosage form: SYRUP
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc
Application: ANDA040654
Marketing category: ANDA
Marketing start: 2006-12-07
Marketing end: 0000-00-00
Substance: PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 6 mg/5mL; mg/5mL
Pharmacologic classes: Phenothiazine [EPC],Phenothiazines [CS],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68788-9100		I	Inactivated by FDA		2026-08-03
excluded package	package	68788-9100	68788-9100-1	I	Inactivated by FDA		2026-08-03

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 · 44 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	68788-9100-1	`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	68788-9100-1	`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	68788-9100-1	`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	68788-9100-1	`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	68788-9100-1	`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	68788-9100-1	`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	68788-9100-1	`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	68788-9100-1	`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	68788-9100-1	`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	68788-9100-1	`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	68788-9100-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68788-9100-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68788-9100-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68788-9100-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68788-9100-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68788-9100-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68788-9100-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68788-9100-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68788-9100-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68788-9100-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68788-9100-1	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68788-9100-1	`110d247fa046…`	`a55b01930146…`

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

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
A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040654-001	AA

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040654-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040654-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040654-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040654-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040654-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040654-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040654-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040654-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040654-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040654-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040654-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040654-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040654-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040654-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040654-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040654-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040654-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040654-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040654-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040654-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040654-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040654-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040654-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040654-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040654-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040654-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040654-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040654-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040654-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040654-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040654-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040654-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040654-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040654-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040654-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040654-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040654-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040654-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040654-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040654-001	AA	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
3036445d-7d13-4411-a100-f2ac5ab8a276	Product name	1	20240110
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
2e7222fb-e3f1-febd-962f-ddbb495d6b5f	Product name	2	20220126
09d8330d-4fec-be98-3a66-f985140646b2	Product name	2	20210513
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
4f881de7-085a-407e-abc2-faa3c0127432	Product name	1	20170811
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
d51697af-7f97-0559-95d1-fe94f3f031d5	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68788-9100-1	2019-10-29	C162847	48780-1	960f7f55-ca91-8e05-e053-dbdaa90a074a	PROMETHAZINE VC SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND PHENYLEPHRINE HYDROCHLORIDE, USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68788-9100-1	Promethazine VC	118 mL in 1 BOTTLE	SYRUP	118		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]	1
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]	1
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]	1
CITRIC ACID	INACTIVE INGREDIENT	2968PHW8QP	PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-9100	PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]	1	Legacy NDC, 1 package rows	20110817_b00b296d-6c34-48c8-9cfb-71ccc5c9a908.zip

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Promethazine Hydrochloride and Phenylephrine Hydrochloride	PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE	Genus Lifesciences Inc.	7f8ebc9c-c4e6-4344-95a5-ec25b8c99bc1	2024-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040654 application number: ANDA040654

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE	58-33-3	PROMETHAZINE HYDROCHLORIDE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1248057	phenylephrine HCl 5 MG / promethazine HCl 6.25 MG in 5 mL Oral Solution	PSN	b00b296d-6c34-48c8-9cfb-71ccc5c9a908	1
1248057	phenylephrine hydrochloride 1 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution	SCD	b00b296d-6c34-48c8-9cfb-71ccc5c9a908	1
1248057	phenylephrine hydrochloride 5 MG / promethazine hydrochloride 6.25 MG per 5 ML Oral Solution	SY	b00b296d-6c34-48c8-9cfb-71ccc5c9a908	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
68788-9100-1	68788910001	118 mL in 1 BOTTLE	118 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROMETHAZINE VC SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND PHENYLEPHRINE HYDROCHLORIDE, USP)	Preferred Pharmaceuticals, Inc	2011-06-10	HUMAN PRESCRIPTION DRUG LABEL	1