Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution

Product NDC: 68788-8100
11-digit product format: 687888100
Labeler code: 68788
Product ID: 68788-8100_259ec19b-1e8f-4e74-b923-9b746db17f8f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution
Dosage form: SOLUTION
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA040649
Marketing category: ANDA
Marketing start: 2021-10-08
Substance: DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
Active strength: 15; 6.25 mg/5mL; mg/5mL
Pharmacologic classes: Phenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	15 mg/5mL
PROMETHAZINE HYDROCHLORIDE	6.25 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
R61ZEH7I1I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
991528	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
88137097-16b3-44b7-8e1f-26a8242d8179	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68788-8100-1	Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution	118 mL in 1 BOTTLE	SOLUTION	118		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8100-1	ML - Milliliter	68788-8100	fd7bddef-99c1-4ccd-8dc8-a563887342a8	1	2021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8100	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION SOLUTION [PREFERRED PHARMACEUTICALS INC.]	4	Current NDC, Legacy NDC, 1 package rows	20240805_88137097-16b3-44b7-8e1f-26a8242d8179.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 ndc (product): 68788-8100
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	88137097-16b3-44b7-8e1f-26a8242d8179	5
991528	dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution	SCD	88137097-16b3-44b7-8e1f-26a8242d8179	5
991528	dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral Solution	SY	88137097-16b3-44b7-8e1f-26a8242d8179	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-8100-1	68788810001	118 mL in 1 BOTTLE (68788-8100-1)	118 ml	2021-10-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Promethazine DM Oral Solution	Preferred Pharmaceuticals Inc.	2025-09-16	HUMAN PRESCRIPTION DRUG LABEL	5