Hydrocodone Bitartrate, Chlorpheniramine Maleate, and Pseudoephedrine HCl

Product NDC: 60258-876
11-digit product format: 602580876
Labeler code: 60258
Product ID: 60258-876_030d7689-e7e1-4698-8731-9a53c06bf074
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydrocodone bitartrate, chlorpheniramine maleate, pseudoephedrine hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Cypress Pharmaceutical, Inc.
Application: NDA022439
Marketing category: NDA
Marketing start: 2014-01-09
Marketing end: 0000-00-00
Substance: HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE
Active strength: 5 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes: Opioid Agonist [EPC],Opioid Agonists [MoA],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	60258-876		D	Discontinued by firm		2026-08-11
excluded package	package	60258-876	60258-876-16	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60258-876-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60258-876-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60258-876-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60258-876-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60258-876-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60258-876-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60258-876-16	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60258-876-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60258-876-16	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60258-876-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	60258-876-16	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	60258-876-16	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N022439-001	ZUTRIPRO	CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2011-06-08

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	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2011-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2011-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2011-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2011-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2011-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2011-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2011-06-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2011-06-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2011-06-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2011-06-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2011-06-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2011-06-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2011-06-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2011-06-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2011-06-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML	SOLUTION / ORAL		RLD	2011-06-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML	SOLUTION / ORAL		RLD	2011-06-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML	SOLUTION / ORAL		RLD	2011-06-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2011-06-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL		RLD	2011-06-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML	SOLUTION / ORAL		RLD	2011-06-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML	SOLUTION / ORAL		RLD	2011-06-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML	SOLUTION / ORAL		RLD	2011-06-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML	SOLUTION / ORAL		RLD	2011-06-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML	SOLUTION / ORAL		RLD	2011-06-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML	SOLUTION / ORAL		RLD	2011-06-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2011-06-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2011-06-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2011-06-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2011-06-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2011-06-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2011-06-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2011-06-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2011-06-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2011-06-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2011-06-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2011-06-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2011-06-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2011-06-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2011-06-08	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	N022439-001	AA	1	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60258-876-16	2020-02-27	C162847	48780-1	9d75b9d0-626e-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Hydrocodone Bitratrate, Pseudoephedrine Hydrochloride, and Chlorpheniramine Maleate safely and effectively. See full prescribing information for Hydrocodone Bitratrate, Pseudoephedrine Hydrochloride, and Chlorpheniramine Maleate. Hydrocodone Bitratrate, Pseudoephedrine Hydrochloride, and Chlorpheniramine Maleate oral solution, CII Initial U.S. Approval: 2011
60258-876-16	2020-01-31	C162847	48780-1	9d75b9d0-626e-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Hydrocodone Bitratrate, Pseudoephedrine Hydrochloride, and Chlorpheniramine Maleate safely and effectively. See full prescribing information for Hydrocodone Bitratrate, Pseudoephedrine Hydrochloride, and Chlorpheniramine Maleate. Hydrocodone Bitratrate, Pseudoephedrine Hydrochloride, and Chlorpheniramine Maleate oral solution, CII Initial U.S. Approval: 2011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60258-876-16	ML - Milliliter	60258-876	3bb3a1dd-9cdf-46e9-9719-bff3d2ff9634	1	2014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHLORPHENIRAMINE MALEATE	ACTIVE INGREDIENT	V1Q0O9OJ9Z	HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HCL (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [CYPRESS PHARMACEUTICAL, INC.]	3
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HCL (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [CYPRESS PHARMACEUTICAL, INC.]	3
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HCL (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [CYPRESS PHARMACEUTICAL, INC.]	3
CHLORPHENIRAMINE	ACTIVE MOIETY	3U6IO1965U	HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HCL (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [CYPRESS PHARMACEUTICAL, INC.]	3
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HCL (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [CYPRESS PHARMACEUTICAL, INC.]	3
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HCL (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [CYPRESS PHARMACEUTICAL, INC.]	3
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HCL (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [CYPRESS PHARMACEUTICAL, INC.]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HCL (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [CYPRESS PHARMACEUTICAL, INC.]	3
GRAPE	INACTIVE INGREDIENT	6X543N684K	HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HCL (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [CYPRESS PHARMACEUTICAL, INC.]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HCL (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [CYPRESS PHARMACEUTICAL, INC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HCL (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [CYPRESS PHARMACEUTICAL, INC.]	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HCL (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [CYPRESS PHARMACEUTICAL, INC.]	3
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HCL (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [CYPRESS PHARMACEUTICAL, INC.]	3
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HCL (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [CYPRESS PHARMACEUTICAL, INC.]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HCL (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [CYPRESS PHARMACEUTICAL, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HCL (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [CYPRESS PHARMACEUTICAL, INC.]	3

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NO70W886KK	HYDROCODONE BITARTRATE	34195-34-1	HYDROCODONE BITARTRATE
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE
V1Q0O9OJ9Z	CHLORPHENIRAMINE MALEATE	113-92-8	CHLORPHENIRAMINE MALEATE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocodone Bitartrate, Chlorpheniramine Maleate, and Pseudoephedrine HCl	Cypress Pharmaceutical, Inc. \| Woodfield Pharmaceutical, LLC	2018-07-06	HUMAN PRESCRIPTION DRUG LABEL	5