Promethazine Hydrochloride and Dextromethorphan Hydrobromide

Product NDC: 65162-680
11-digit product format: 651620680
Labeler code: 65162
Product ID: 65162-680_5897cff8-507a-42b0-bcf2-4712589704df
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Dosage form: SOLUTION
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA090575
Marketing category: ANDA
Marketing start: 2011-03-04
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
A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA		2011-02-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090575-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		2011-02-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		2011-02-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		2011-02-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		2011-02-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`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	A090575-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090575-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090575-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090575-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090575-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090575-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090575-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090575-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090575-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090575-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090575-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090575-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090575-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090575-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090575-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090575-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090575-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A090575-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090575-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090575-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090575-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090575-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090575-001	AA	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090575-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090575-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090575-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090575-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090575-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090575-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090575-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090575-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090575-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090575-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090575-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090575-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090575-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090575-001	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
6081c216-0bed-40f0-8732-f999647003d5	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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
65162-680-86	Promethazine Hydrochloride and Dextromethorphan Hydrobromide	118 mL in 1 BOTTLE	SOLUTION	118		13
65162-680-90	Promethazine Hydrochloride and Dextromethorphan Hydrobromide	473 mL in 1 BOTTLE	SOLUTION	473		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-680-86	ML - Milliliter	65162-680	de61bbab-6ca7-43e4-bd58-c10ecda39c0e	1	2020-04-20
65162-680-90	ML - Milliliter	65162-680	58da79f1-52d9-4e82-a382-8311f820242e	1	2020-04-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	PROMETHAZINE HYDROCHLORIDE AND DEXTOMETHORPHAN HYDROBROMIDE SOLUTION [AMNEAL PHARMACEUTICALS]	1
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE AND DEXTOMETHORPHAN HYDROBROMIDE SOLUTION [AMNEAL PHARMACEUTICALS]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	PROMETHAZINE HYDROCHLORIDE AND DEXTOMETHORPHAN HYDROBROMIDE SOLUTION [AMNEAL PHARMACEUTICALS]	1
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE AND DEXTOMETHORPHAN HYDROBROMIDE SOLUTION [AMNEAL PHARMACEUTICALS]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	PROMETHAZINE HYDROCHLORIDE AND DEXTOMETHORPHAN HYDROBROMIDE SOLUTION [AMNEAL PHARMACEUTICALS]	1
BERRY	INACTIVE INGREDIENT	FV3431923Z	PROMETHAZINE HYDROCHLORIDE AND DEXTOMETHORPHAN HYDROBROMIDE SOLUTION [AMNEAL PHARMACEUTICALS]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	PROMETHAZINE HYDROCHLORIDE AND DEXTOMETHORPHAN HYDROBROMIDE SOLUTION [AMNEAL PHARMACEUTICALS]	1
EDETATE CALCIUM DISODIUM	INACTIVE INGREDIENT	25IH6R4SGF	PROMETHAZINE HYDROCHLORIDE AND DEXTOMETHORPHAN HYDROBROMIDE SOLUTION [AMNEAL PHARMACEUTICALS]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PROMETHAZINE HYDROCHLORIDE AND DEXTOMETHORPHAN HYDROBROMIDE SOLUTION [AMNEAL PHARMACEUTICALS]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PROMETHAZINE HYDROCHLORIDE AND DEXTOMETHORPHAN HYDROBROMIDE SOLUTION [AMNEAL PHARMACEUTICALS]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	PROMETHAZINE HYDROCHLORIDE AND DEXTOMETHORPHAN HYDROBROMIDE SOLUTION [AMNEAL PHARMACEUTICALS]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	PROMETHAZINE HYDROCHLORIDE AND DEXTOMETHORPHAN HYDROBROMIDE SOLUTION [AMNEAL PHARMACEUTICALS]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	PROMETHAZINE HYDROCHLORIDE AND DEXTOMETHORPHAN HYDROBROMIDE SOLUTION [AMNEAL PHARMACEUTICALS]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	PROMETHAZINE HYDROCHLORIDE AND DEXTOMETHORPHAN HYDROBROMIDE SOLUTION [AMNEAL PHARMACEUTICALS]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PROMETHAZINE HYDROCHLORIDE AND DEXTOMETHORPHAN HYDROBROMIDE SOLUTION [AMNEAL PHARMACEUTICALS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PROMETHAZINE HYDROCHLORIDE AND DEXTOMETHORPHAN HYDROBROMIDE SOLUTION [AMNEAL PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-680	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SOLUTION [AMNEAL PHARMACEUTICALS LLC]	13	Current NDC, Legacy NDC, 2 package rows	20241031_6081c216-0bed-40f0-8732-f999647003d5.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 · 1 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	Amneal Pharmaceuticals LLC	6081c216-0bed-40f0-8732-f999647003d5	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090575 application number: ANDA090575 ndc (product): 65162-680

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	6081c216-0bed-40f0-8732-f999647003d5	13
991528	dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution	SCD	6081c216-0bed-40f0-8732-f999647003d5	13
991528	dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral Solution	SY	6081c216-0bed-40f0-8732-f999647003d5	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-680-86	65162068086	118 mL in 1 BOTTLE (65162-680-86)	118 ml	2011-03-04	0000-00-00	No	No	Current
65162-680-90	65162068090	473 mL in 1 BOTTLE (65162-680-90)	473 ml	2011-03-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution	Amneal Pharmaceuticals LLC	2024-10-30	HUMAN PRESCRIPTION DRUG LABEL	13