Promethazine Hydrochloride and Dextromethorphan Hydrobromide

Product NDC: 27808-057
11-digit product format: 278080057
Labeler code: 27808
Product ID: 27808-057_c48beb7d-69be-4ace-82b1-d1a1210b7f32
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Dosage form: SOLUTION
Route: ORAL
Labeler: Cranbury Pharmaceuticals, LLC
Application: ANDA091687
Marketing category: ANDA
Marketing start: 2014-01-31
Marketing end: 2027-04-01
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
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
A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA		2012-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091687-001	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	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2012-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2012-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2012-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2012-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2012-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2012-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2012-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2012-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2012-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2012-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2012-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2012-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2012-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2012-06-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2012-06-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2012-06-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2012-06-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		2012-06-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2012-06-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2012-06-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		2012-06-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		2012-06-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		2012-06-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		2012-06-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		2012-06-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		2012-06-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		2012-06-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2012-06-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2012-06-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2012-06-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2012-06-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2012-06-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2012-06-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2012-06-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2012-06-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2012-06-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2012-06-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2012-06-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2012-06-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091687-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2012-06-28	`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	A091687-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091687-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091687-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091687-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091687-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091687-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091687-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091687-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091687-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091687-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091687-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091687-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091687-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091687-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091687-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091687-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091687-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A091687-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091687-001	AA	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091687-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091687-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091687-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091687-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091687-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091687-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091687-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091687-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091687-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091687-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091687-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091687-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091687-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A091687-001	AA	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Promethazine Hydrochloride and Dextromethorphan Hydrobromide

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
a8b57027-a4b8-4149-93e8-aa3e7a6d6dc3	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
27808-057-01	Promethazine Hydrochloride and Dextromethorphan Hydrobromide	473 mL in 1 BOTTLE, PLASTIC	SOLUTION	473		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
27808-057-01	ML - Milliliter	27808-057	b0a9712c-ba69-4b7e-88f3-62124badd4cc	1	2021-11-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [TRIS PHARMA INC]	2
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [TRIS PHARMA INC]	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [TRIS PHARMA INC]	2
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [TRIS PHARMA INC]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [TRIS PHARMA INC]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [TRIS PHARMA INC]	2
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [TRIS PHARMA INC]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [TRIS PHARMA INC]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [TRIS PHARMA INC]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [TRIS PHARMA INC]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [TRIS PHARMA INC]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [TRIS PHARMA INC]	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [TRIS PHARMA INC]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [TRIS PHARMA INC]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [TRIS PHARMA INC]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [TRIS PHARMA INC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [TRIS PHARMA INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
27808-057	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SOLUTION [CRANBURY PHARMACEUTICALS, LLC]	9	Current NDC, Legacy NDC, 1 package rows	20250406_a8b57027-a4b8-4149-93e8-aa3e7a6d6dc3.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	Bryant Ranch Prepack	709519cb-d124-4469-b329-b67e1bba214b	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091687 application number: ANDA091687
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	Cranbury Pharmaceuticals, LLC	a8b57027-a4b8-4149-93e8-aa3e7a6d6dc3	2025-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091687 application number: ANDA091687 ndc (product): 27808-057
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	Cosette Pharmaceuticals, Inc.	e7b336d9-b1df-4a08-9b67-754346d365f4	2025-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091687 application number: ANDA091687
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	A-S Medication Solutions	e451cb8d-f856-479f-bee9-4cccab210b1e	2024-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091687 application number: ANDA091687

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	709519cb-d124-4469-b329-b67e1bba214b	103
991528	dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution	SCD	709519cb-d124-4469-b329-b67e1bba214b	103
991528	dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral Solution	SY	709519cb-d124-4469-b329-b67e1bba214b	103
991528	promethazine HCl 6.25 MG / dextromethorphan HBr 15 MG in 5 mL Oral Solution	PSN	a8b57027-a4b8-4149-93e8-aa3e7a6d6dc3	10
991528	dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution	SCD	a8b57027-a4b8-4149-93e8-aa3e7a6d6dc3	10
991528	dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral Solution	SY	a8b57027-a4b8-4149-93e8-aa3e7a6d6dc3	10
991528	promethazine HCl 6.25 MG / dextromethorphan HBr 15 MG in 5 mL Oral Solution	PSN	e451cb8d-f856-479f-bee9-4cccab210b1e	5
991528	dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution	SCD	e451cb8d-f856-479f-bee9-4cccab210b1e	5
991528	dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral Solution	SY	e451cb8d-f856-479f-bee9-4cccab210b1e	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
27808-057-01	27808005701	473 mL in 1 BOTTLE, PLASTIC (27808-057-01)	473 ml	2021-11-15	2027-04-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution	Bryant Ranch Prepack	2026-03-20	HUMAN PRESCRIPTION DRUG LABEL	103
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution	Cranbury Pharmaceuticals, LLC	2025-12-12	HUMAN PRESCRIPTION DRUG LABEL	10
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution	A-S Medication Solutions	2024-02-12	HUMAN PRESCRIPTION DRUG LABEL	5