Corphena

Product NDC: 73684-300
11-digit product format: 736840300
Labeler code: 73684
Product ID: 73684-300_4694618d-6999-29b1-e063-6394a90ab004
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexchlorpheniramine Maleate
Dosage form: SOLUTION
Route: ORAL
Labeler: BluCrest Pharmaceuticals LLC
Application: ANDA202520
Marketing category: ANDA
Marketing start: 2025-10-22
Substance: DEXCHLORPHENIRAMINE MALEATE
Active strength: 2 mg/5mL
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 42.

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
A202520-001	POLMON	DEXCHLORPHENIRAMINE MALEATE	2MG/5ML	SYRUP / ORAL		RS	2018-07-16

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 · 42 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
2026-08-18 06:07:40	2026-07	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL		RS	2018-07-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL		RS	2018-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL		RS	2018-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL		RS	2018-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL		RS	2018-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL		RS	2018-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL		RS	2018-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL		RS	2018-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL		RS	2018-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL		RS	2018-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL		RS	2018-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL		RS	2018-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL		RS	2018-07-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL		RS	2018-07-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL		RS	2018-07-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202520-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202520-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202520-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202520-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202520-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202520-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202520-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202520-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202520-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202520-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202520-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202520-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202520-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202520-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202520-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202520-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202520-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202520-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202520-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202520-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202520-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202520-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202520-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202520-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202520-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202520-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Corphena
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXCHLORPHENIRAMINE MALEATE	2 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
B10YD955QW	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2183907	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
4694616b-4ef4-28a4-e063-6394a90ac5f6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
44893bf2-1be4-4e68-8bc4-bbb0f543085e	Product name	1	20180830

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73684-300-08	Corphena	237 mL in 1 BOTTLE, PLASTIC	SOLUTION	237		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
73684-300-08	ML - Milliliter	73684-300	0a8cfaef-54bb-424b-8c50-50fd62388dfa	1	2026-02-05

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
Corphena	DEXCHLORPHENIRAMINE MALEATE	BluCrest Pharmaceuticals LLC	4694616b-4ef4-28a4-e063-6394a90ac5f6	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202520 application number: ANDA202520 ndc (product): 73684-300
RYCLORA	DEXCHLORPHENIRAMINE MALEATE	CARWIN PHARMACEUTICAL ASSOCIATES, LLC	aa4f80c9-e600-4bc0-8528-02a8162a36f0	2024-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202520 application number: ANDA202520

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
B10YD955QW	DEXCHLORPHENIRAMINE MALEATE	2438-32-6	DEXCHLORPHENIRAMINE MALEATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2183907	dexchlorpheniramine maleate 2 MG in 5 mL Oral Solution	PSN	4694616b-4ef4-28a4-e063-6394a90ac5f6	1
2183907	dexchlorpheniramine maleate 0.4 MG/ML Oral Solution	SCD	4694616b-4ef4-28a4-e063-6394a90ac5f6	1
2183907	dexchlorpheniramine 2 MG per 5 ML Oral Solution	SY	4694616b-4ef4-28a4-e063-6394a90ac5f6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
73684-300-08	73684030008	237 mL in 1 BOTTLE, PLASTIC (73684-300-08)	237 ml	2025-12-22	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CORPHONA (dexchlorpheniramine maleate) Oral Solution, USP	BluCrest Pharmaceuticals LLC	2025-12-22	HUMAN PRESCRIPTION DRUG LABEL	1