Promethazine Hydrochloride and Dextromethorphan Hydrobromide

Product NDC: 76420-335
11-digit product format: 764200335
Labeler code: 76420
Product ID: 76420-335_348f2d59-90ce-1534-e063-6294a90a960a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Dosage form: SOLUTION
Route: ORAL
Labeler: Asclemed USA, Inc.
Application: NDA011265
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2024-09-05
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
N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1984-04-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N011265-002	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	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1984-04-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1984-04-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1984-04-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1984-04-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1984-04-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1984-04-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1984-04-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL		RLD	1984-04-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1984-04-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1984-04-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL		RLD	1984-04-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL		RLD	1984-04-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL		RLD	1984-04-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL		RLD	1984-04-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL		RLD	1984-04-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		RLD	1984-04-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		RLD	1984-04-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL		RLD	1984-04-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL		RLD	1984-04-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL		RLD	1984-04-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL		RLD	1984-04-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL		RLD	1984-04-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL		RLD	1984-04-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL		RLD	1984-04-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL		RLD	1984-04-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL		RLD	1984-04-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL		RLD	1984-04-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL		RLD	1984-04-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL		RLD	1984-04-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL		RLD	1984-04-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL		RLD	1984-04-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL		RLD	1984-04-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL		RLD	1984-04-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL		RLD	1984-04-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL		RLD	1984-04-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL		RLD	1984-04-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL		RLD	1984-04-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL		RLD	1984-04-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL		RLD	1984-04-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N011265-002	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL		RLD	1984-04-02	`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	N011265-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011265-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011265-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011265-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011265-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011265-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011265-002	AA	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011265-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N011265-002	AA	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N011265-002	AA	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PROMETHAZINE HYDROCHLORIDE	15 mg/5mL
DEXTROMETHORPHAN HYDROBROMIDE	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
R61ZEH7I1I	Internal UNII lookup
9D2RTI9KYH	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
702eb7c0-db4c-4729-b69e-99f64c63c7bd	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
76420-335-04	Promethazine Hydrochloride and Dextromethorphan Hydrobromide	118 mL in 1 BOTTLE	SOLUTION	118		2
76420-335-16	Promethazine Hydrochloride and Dextromethorphan Hydrobromide	473 mL in 1 BOTTLE	SOLUTION	473		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-335	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SOLUTION [ASCLEMED USA, INC.]	2	Current NDC, 2 package rows	20250508_702eb7c0-db4c-4729-b69e-99f64c63c7bd.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 · 2 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	ANI Pharmaceuticals, Inc.	a52e210f-b99d-493e-b679-ec565c6ff72d	2025-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 011265 application number: NDA011265
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	Asclemed USA, Inc.	702eb7c0-db4c-4729-b69e-99f64c63c7bd	2025-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 011265 application number: NDA011265 ndc (product): 76420-335

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	702eb7c0-db4c-4729-b69e-99f64c63c7bd	2
991528	dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution	SCD	702eb7c0-db4c-4729-b69e-99f64c63c7bd	2
991528	dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral Solution	SY	702eb7c0-db4c-4729-b69e-99f64c63c7bd	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
76420-335-04	76420033504	118 mL in 1 BOTTLE (76420-335-04)	118 ml	2025-04-22	No	No	Current
76420-335-16	76420033516	473 mL in 1 BOTTLE (76420-335-16)	473 ml	2025-04-22	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution Rx Only	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-05-07	HUMAN PRESCRIPTION DRUG LABEL	2