Promethazine Hydrochloride and Dextromethorphan Hydrobromide

Product NDC: 60432-604
11-digit product format: 604320604
Labeler code: 60432
Product ID: 60432-604_6f4828f7-fdde-43d5-bd8c-bdf9d68b07a1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: promethazine hydrochloride and dextromethorphan hydrobromide
Dosage form: SYRUP
Route: ORAL
Labeler: Morton Grove Pharmaceuticals, Inc.
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: 2022-12-31
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	60432-604		D	Discontinued by firm		2026-08-17
excluded package	package	60432-604	60432-604-16	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 · 30 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	60432-604-16	`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	60432-604-16	`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	60432-604-16	`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	60432-604-16	`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	60432-604-16	`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	60432-604-16	`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	60432-604-16	`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	60432-604-16	`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	60432-604-16	`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	60432-604-16	`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	60432-604-16	`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	60432-604-16	`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	60432-604-16	`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	60432-604-16	`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	60432-604-16	`1332a3947898…`	`d4bfe170f9cd…`

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…`

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
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
60432-604-16	2025-12-12	C162847	48780-1	f386c64a-4209-0266-e053-dadaa90a7c1a	Promethazine with Dextromethorphan Cough Syrup (Promethazine Hydrochloride 6.25 mg/5 mL & Dextromethorphan Hydrobromide 15 mg/5 mL) Rx only
60432-604-16	2023-01-30	C162847	48780-1	f386c64a-4209-0266-e053-dadaa90a7c1a	Promethazine with Dextromethorphan Cough Syrup (Promethazine Hydrochloride 6.25 mg/5 mL & Dextromethorphan Hydrobromide 15 mg/5 mL) Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60432-604-04	ML - Milliliter	60432-604	19f7db32-8099-4e93-9a3b-4b1221a09adf	1	2012-07-24
60432-604-16	ML - Milliliter	60432-604	c1134aae-95bb-4a1b-8f5d-859dac1302f2	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Dextromethorphan Hydrobromide	ACTIVE INGREDIENT	9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	3
Dextromethorphan Hydrobromide	ACTIVE INGREDIENT	9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]	3
Promethazine Hydrochloride	ACTIVE INGREDIENT	R61ZEH7I1I	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	3
Promethazine Hydrochloride	ACTIVE INGREDIENT	R61ZEH7I1I	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]	3
Dextromethorphan	ACTIVE MOIETY	7355X3ROTS	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	3
Dextromethorphan	ACTIVE MOIETY	7355X3ROTS	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]	3
Promethazine	ACTIVE MOIETY	FF28EJQ494	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	3
Promethazine	ACTIVE MOIETY	FF28EJQ494	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]	3
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]	3
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	3
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	3
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	3
PINEAPPLE	INACTIVE INGREDIENT	2A88ZO081O	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	3
PINEAPPLE	INACTIVE INGREDIENT	2A88ZO081O	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]	3
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	3
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]	3
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	3
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]	3
SODIUM PROPIONATE	INACTIVE INGREDIENT	DK6Y9P42IN	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]	3
SODIUM PROPIONATE	INACTIVE INGREDIENT	DK6Y9P42IN	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]	3
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	3
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]	3
Dextromethorphan hydrobromide	ACTIVE INGREDIENT	9D2RTI9KYH	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
Promethazine hydrochloride	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
Dextromethorphan	ACTIVE MOIETY	7355X3ROTS	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
Promethazine	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
ascorbic acid	INACTIVE INGREDIENT	PQ6CK8PD0R	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
saccharin sodium	INACTIVE INGREDIENT	SB8ZUX40TY	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
sodium propionate	INACTIVE INGREDIENT	DK6Y9P42IN	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
water	INACTIVE INGREDIENT	059QF0KO0R	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60432-604	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	8	Legacy NDC	20210112_620478d3-aee5-488e-a337-3ad197ede6b6.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

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	ba7ad7f8-3261-4977-a13a-f6e07c510a9a	5
991528	dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution	SCD	ba7ad7f8-3261-4977-a13a-f6e07c510a9a	5
991528	dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral Solution	SY	ba7ad7f8-3261-4977-a13a-f6e07c510a9a	5
991528	promethazine HCl 6.25 MG / dextromethorphan HBr 15 MG in 5 mL Oral Solution	PSN	4de7fb46-3610-44c4-a9bf-e7fe287da70b	1
991528	promethazine HCl 6.25 MG / dextromethorphan HBr 15 MG in 5 mL Oral Solution	PSN	56dfd62c-d386-4e9f-9946-07eda94fa122	1
991528	dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution	SCD	4de7fb46-3610-44c4-a9bf-e7fe287da70b	1
991528	dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution	SCD	56dfd62c-d386-4e9f-9946-07eda94fa122	1
991528	dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral Solution	SY	4de7fb46-3610-44c4-a9bf-e7fe287da70b	1
991528	dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral Solution	SY	56dfd62c-d386-4e9f-9946-07eda94fa122	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60432-604-16	60432060416	473 mL in 1 BOTTLE, PLASTIC (60432-604-16)	473 ml	1985-01-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROMETHAZINE WITH DEXTROMETHORPHAN COUGH SYRUP	ATLANTIC BIOLOGICALS CORP.	2024-06-05	HUMAN PRESCRIPTION DRUG LABEL	5
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	Morton Grove Pharmaceuticals, Inc.	2021-01-11	HUMAN PRESCRIPTION DRUG LABEL	8
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	A-S Medication Solutions	2020-03-16	HUMAN PRESCRIPTION DRUG LABEL	1
PROMETHAZINE WITH DEXTROMETHORPHAN COUGH SYRUP	Proficient Rx LP	2019-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
PROMETHAZINE WITH DEXTROMETHORPHAN COUGH SYRUP	Rebel Distributors Corp	2011-01-04	HUMAN PRESCRIPTION DRUG LABEL	1