PROMETHAZINE DM

Product NDC: 63187-272
11-digit product format: 631870272
Labeler code: 63187
Product ID: 63187-272_0d8718f0-8fa5-413b-bf23-5ffc1b190f85
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dextromethorphan Hydrobromide and Promethazine Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA040649
Marketing category: ANDA
Marketing start: 2006-02-14
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63187-272		D	Discontinued by firm		2026-08-11
excluded package	package	63187-272	63187-272-04	D	Discontinued by firm		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 · 6 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	63187-272-04	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	63187-272-04	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63187-272-04	E	Excluded after deficient or non-compliant submission was not corrected	`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
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 Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	PROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]	1
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	PROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]	1
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	PROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	PROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	PROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	PROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	PROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	PROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	PROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	PROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-272	PROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SOLUTION [PROFICIENT RX LP]	2	Legacy NDC	20191212_17bae9bf-ab07-4366-b400-871360c8969b.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-272-04	63187027204	118 mL in 1 BOTTLE (63187-272-04)	118 ml	2015-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROMETHAZINE DM SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND DEXTROMETHORPHAN HYDROBROMIDE, USP)	Proficient Rx LP	2019-12-01	HUMAN PRESCRIPTION DRUG LABEL	2