Dextromethorphan Hydrobromide and Promethazine Hydrochloride

Product NDC: 63187-355
11-digit product format: 631870355
Labeler code: 63187
Product ID: 63187-355_237dfeed-9ff8-4ae1-81fd-1322cf252599
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dextromethorphan Hydrobromide and Promethazine Hydrochloride
Dosage form: SYRUP
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA088864
Marketing category: ANDA
Marketing start: 1985-01-04
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: 2020-12-31
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	63187-355		D	Discontinued by firm	2026-08-17
excluded package	package	63187-355	63187-355-04	D	Discontinued by firm	2026-08-17
excluded package	package	63187-355	63187-355-16	D	Discontinued by firm	2026-08-17

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 · 57 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-355-16	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-355-04	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-355-16	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-355-04	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63187-355-04	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63187-355-16	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63187-355-04	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63187-355-16	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63187-355-04	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63187-355-16	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63187-355-04	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63187-355-16	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63187-355-04	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63187-355-16	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63187-355-04	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63187-355-16	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63187-355-04	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63187-355-16	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63187-355-04	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63187-355-16	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63187-355-04	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63187-355-16	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63187-355-04	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63187-355-16	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	63187-355-04	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	63187-355-16	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63187-355-04	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63187-355-16	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63187-355-04	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63187-355-16	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	63187-355-04	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	63187-355-16	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	63187-355-04	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	63187-355-16	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	63187-355-04	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	63187-355-16	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	63187-355-04	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	63187-355-16	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA		1985-01-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A088864-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088864-001	PROMETHAZINE W/ DEXTROMETHORPHAN	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1985-01-04	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A088864-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088864-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088864-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088864-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088864-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088864-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088864-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088864-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088864-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088864-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088864-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088864-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088864-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088864-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088864-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088864-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088864-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088864-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088864-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088864-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088864-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088864-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088864-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088864-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088864-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088864-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088864-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088864-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088864-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088864-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088864-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088864-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088864-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088864-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088864-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088864-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088864-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088864-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088864-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088864-001	AA	1	`e64feba35796…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63187-355-04	2025-06-25	PROMETHAZINE WITH DEXTROMETHORPHAN COUGH SYRUP
63187-355-16	2025-06-25	PROMETHAZINE WITH DEXTROMETHORPHAN COUGH SYRUP
63187-355-04	2021-01-29	PROMETHAZINE WITH DEXTROMETHORPHAN COUGH SYRUP
63187-355-16	2021-01-29	PROMETHAZINE WITH DEXTROMETHORPHAN COUGH SYRUP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-355-16	ML - Milliliter	63187-355	de6b153d-c74f-4375-8224-8b80a2b677cf	1	2018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-355	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]	3	Legacy NDC	20190130_c155b478-c04d-47e5-891b-408d09a5acf3.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	Atlantic Biologicals Corp.	5022379d-05ef-63f2-e063-6294a90a2189	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088864 application number: ANDA088864
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	A-S Medication Solutions	87f9e9fb-5433-478b-9f23-e16883a9d2a9	2025-09-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088864 application number: ANDA088864
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	Xttrium Laboratories, Inc	30c9d769-bc74-04d2-e063-6294a90a665a	2025-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088864 application number: ANDA088864
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	A-S Medication Solutions	ee227c52-2cd8-4a06-a2de-a257f1f4732a	2023-07-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088864 application number: ANDA088864

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROMETHAZINE WITH DEXTROMETHORPHAN COUGH SYRUP	Proficient Rx LP	2019-01-01	HUMAN PRESCRIPTION DRUG LABEL	3