PROMETHAZINE DM

Product NDC: 17856-1586
11-digit product format: 178561586
Labeler code: 17856
Product ID: 17856-1586_e4a30df6-0703-4bc0-9672-1eca50449b64
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dextromethorphan Hydrobromide and Promethazine Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: ATLANTIC BIOLOGICALS CORP.
Application: ANDA040649
Marketing category: ANDA
Marketing start: 2018-06-01
Marketing end: 0000-00-00
Substance: DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
Active strength: 15 mg/5mL; mg/5mL
Pharmacologic classes: Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag: No
Listing certified through: 2019-12-31
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	17856-1586		I	Inactivated by FDA		2026-08-11
excluded package	package	17856-1586	17856-1586-1	I	Inactivated by FDA		2026-08-11

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 · 42 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	17856-1586-1	`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	17856-1586-1	`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	17856-1586-1	`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	17856-1586-1	`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	17856-1586-1	`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	17856-1586-1	`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	17856-1586-1	`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	17856-1586-1	`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	17856-1586-1	`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	17856-1586-1	`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	17856-1586-1	`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	17856-1586-1	`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	17856-1586-1	`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	17856-1586-1	`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	17856-1586-1	`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	17856-1586-1	`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	17856-1586-1	`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	17856-1586-1	`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	17856-1586-1	`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	17856-1586-1	`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	17856-1586-1	`9bebd1f3094a…`	`5416666fcb17…`

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
A040649-001	PROMETHAZINE DM	DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040649-001	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	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL			2006-02-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL			2006-02-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL			2006-02-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL			2006-02-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040649-001	PROMETHAZINE DM	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-02-14	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040649-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040649-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040649-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040649-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040649-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040649-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040649-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040649-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040649-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040649-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040649-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040649-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040649-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040649-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040649-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040649-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040649-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A040649-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040649-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040649-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040649-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040649-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040649-001	AA	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040649-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040649-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040649-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040649-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040649-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040649-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040649-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040649-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040649-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040649-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040649-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040649-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040649-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040649-001	AA	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
3036445d-7d13-4411-a100-f2ac5ab8a276	Product name	1	20240110
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
2e7222fb-e3f1-febd-962f-ddbb495d6b5f	Product name	2	20220126
09d8330d-4fec-be98-3a66-f985140646b2	Product name	2	20210513
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
17856-1586-1	2020-01-31	C162847	48780-1	9d75b9d0-7f06-f424-e053-dadaa90a57ce	Promethazine DM Oral Solution (Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17856-1586-1	PROMETHAZINE DM	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17856-1586-1	ML - Milliliter	17856-1586	461a6cd9-6491-4437-8786-7090990770c9	1	2019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-1586	PROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SOLUTION [ATLANTIC BIOLOGICALS CORP.]	1	Legacy NDC, 1 package rows	20180601_3f047079-1957-41e6-bf81-3f6d2e55b5af.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION	ATLANTIC BIOLOGICALS CORP.	3983d6d3-8bf4-4a88-962f-9bf72fd6e685	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040649 application number: ANDA040649
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION	Preferred Pharmaceuticals Inc.	88137097-16b3-44b7-8e1f-26a8242d8179	2025-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040649 application number: ANDA040649
Promethazine DM	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	PAI Holdings, LLC dba PAI Pharma	1d47280d-28c9-4701-8c5f-a6e6b524083b	2025-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040649 application number: ANDA040649
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION	NuCare Pharmaceuticals,Inc.	0b7bfbab-decb-970c-e063-6394a90a50ef	2025-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040649 application number: ANDA040649
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL	A-S Medication Solutions	9c3e0e87-b2f5-4a09-9db8-6d088d2a5f25	2023-08-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040649 application number: ANDA040649
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION	Proficient Rx LP	68a4c521-6db0-4e94-9906-96e96e251301	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040649 application number: ANDA040649

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE	58-33-3	PROMETHAZINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
991528	promethazine HCl 6.25 MG / dextromethorphan HBr 15 MG in 5 mL Oral Solution	PSN	3f047079-1957-41e6-bf81-3f6d2e55b5af	1
991528	dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution	SCD	3f047079-1957-41e6-bf81-3f6d2e55b5af	1
991528	dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral Solution	SY	3f047079-1957-41e6-bf81-3f6d2e55b5af	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
17856-1586-1	17856158601	5 mL in 1 CUP, UNIT-DOSE	5 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Promethazine DM Oral Solution (Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution)	ATLANTIC BIOLOGICALS CORP.	2018-06-01	HUMAN PRESCRIPTION DRUG LABEL	1