SudoGest

Product NDC: 0904-5351
11-digit product format: 009045351
Labeler code: 0904
Product ID: 0904-5351_1b9122c9-f8eb-494a-b64b-cc16ca154e29
Type: HUMAN OTC DRUG
Nonproprietary name: Chlorpheniramine maleate, pseudoephedrine HCl
Dosage form: TABLET
Route: ORAL
Labeler: Major Pharmaceuticals
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1992-12-16
Substance: CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 4; 60 mg/1; mg/1
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0904-5351	0904-5351-96	D	Discontinued by firm		2026-10-20

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 · 12 matching rows.

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

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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: SudoGest
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLORPHENIRAMINE MALEATE	4 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE	60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V1Q0O9OJ9Z	Internal UNII lookup
6V9V2RYJ8N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
998254	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
7cd8f7f3-c262-4f7c-bcaf-068be2c952f9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0904-5351-24	SudoGest	24 in 1 BLISTER PACK	TABLET	24	22
0904-5351-24	SudoGest	1 in 1 CARTON	TABLET	1	22
0904-5351-96	SudoGest	2 in 1 CARTON	TABLET	2	22
0904-5351-96	SudoGest	24 in 1 BLISTER PACK	TABLET	24	22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-5351-24	EA - Each	0904-5351	0f9a6680-4520-4451-8edd-397fa5e3476b	1	2013-02-13
0904-5351-96	EA - Each	0904-5351	42cabb83-be5b-4ab6-8e48-2ec71619f103	1	2013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHLORPHENIRAMINE MALEATE	ACTIVE INGREDIENT	V1Q0O9OJ9Z	SUDOGEST (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE HCL) TABLET [MAJOR PHARMACEUTICALS]	8
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	SUDOGEST (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE HCL) TABLET [MAJOR PHARMACEUTICALS]	8
CHLORPHENIRAMINE	ACTIVE MOIETY	3U6IO1965U	SUDOGEST (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE HCL) TABLET [MAJOR PHARMACEUTICALS]	8
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	SUDOGEST (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE HCL) TABLET [MAJOR PHARMACEUTICALS]	8
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	SUDOGEST (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE HCL) TABLET [MAJOR PHARMACEUTICALS]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SUDOGEST (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE HCL) TABLET [MAJOR PHARMACEUTICALS]	8
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SUDOGEST (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE HCL) TABLET [MAJOR PHARMACEUTICALS]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SUDOGEST (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE HCL) TABLET [MAJOR PHARMACEUTICALS]	8
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SUDOGEST (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE HCL) TABLET [MAJOR PHARMACEUTICALS]	8
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SUDOGEST (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE HCL) TABLET [MAJOR PHARMACEUTICALS]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-5351	SUDOGEST (CHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [MAJOR PHARMACEUTICALS]	20	Current NDC, Legacy NDC, 4 package rows	20250217_7cd8f7f3-c262-4f7c-bcaf-068be2c952f9.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 55 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief Extra Strength	DIPHENHYDRAMINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	4f33c1fb-150b-4083-a9a4-c0fbab4b6133	2026-01-27	Warnings	Exact identifier application number: M012
Cold and Flu Daytime Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution Inc	5ca7dc60-af0c-47c6-b453-8b39c744eb5b	2026-01-27	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	HyVee Inc	2ce5f2af-cabc-466f-b0c5-256e6e6d4c88	2026-01-27	Warnings	Exact identifier application number: M012
Sinus Headache and Pain Day, Non-drowsy	ACETAMINOPHEN, PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	c33340c0-47d3-45e2-997b-3d9fb148900f	2026-01-27	Warnings	Exact identifier application number: M012
Cold and Flu Daytime Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	L.N.K. International, Inc.	b7501b59-d25a-49ec-9cbf-47018bce8397	2026-01-27	Warnings	Exact identifier application number: M012
good sense nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	L. Perrigo Company	f90bd64a-dd1a-4319-87cd-427d57f677ab	2026-01-26	Warnings	Exact identifier application number: M012
Equate Health Non Drowsy DAY Cold and Flu Plus and NIGHTTIME Cold and Flu Plus	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	547ff880-3d40-4a4a-84ee-cd0d5290a9b9	2026-01-26	Warnings	Exact identifier application number: M012
Maximum Strength Non Drowsy Day and Night Cold and Flu	MAXIMUM STRENGTH NON DROWSY DAY AND NIGHT COLD AND FLU	WAL-MART STORES INC	d6a35fb8-1899-4da2-ad2b-0423e332845d	2026-01-26	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN	Prodose, Inc.	7e5de5b0-18f0-4807-8686-da9821f918ce	2026-01-26	Warnings	Exact identifier application number: M012
ALLERGY RELIEF	DIPHENHYDRAMINE HYDROCHLORIDE	Wal-Mart Stores Inc	b9fbf917-12b7-770f-e053-2995a90afe93	2026-01-26	Warnings	Exact identifier application number: M012
Maximum Strength Non Drowsy Daytime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	b58b2c36-a403-4dae-b3b2-f0ffd28a963b	2026-01-26	Warnings	Exact identifier application number: M012
Allergy Relief Dye Free	DIPHENHYDRAMINE HCL	Wal-Mart Stores Inc	870e6bcb-84ab-45e0-ae57-08a9a182eb0b	2026-01-26	Warnings	Exact identifier application number: M012
Allergy Relief Dye Free	DIPHENHYDRAMINE HCL	Wal-Mart Stores Inc	eb8e83a4-981b-48a5-88f4-3a0ba358d3bc	2026-01-26	Warnings	Exact identifier application number: M012
NIGHTTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	8d2d765f-a7e3-40e6-b35d-0e8806a7ea59	2026-01-26	Warnings	Exact identifier application number: M012
NIGHTTIME COLD AND FLU CHERRY	PHENYLEPHRINE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATE	Walgreen Company	02a6781c-aa6f-8fb0-e063-6294a90a043d	2026-01-26	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE SUCCINATE	Walgreen Company	02e5f475-4e9f-2856-e063-6294a90a21fd	2026-01-26	Warnings	Exact identifier application number: M012
GNP Vapor Steam camphor (synthetic)	CAMPHOR (SYNTHETIC)	AmerisourceBergen	0bcc55bf-9654-120b-e063-6394a90a59d1	2026-01-26	Warnings	Exact identifier application number: M012
S2	RACEPINEPHRINE HYDROCHLORIDE	Nephron Pharmaceuticals Corporation	dd1b35c7-b23b-4b95-8162-df3d263fe32e	2026-01-26	Warnings	Exact identifier application number: M012
SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	0d97c634-0975-42d5-8ade-2ed2018cfe9d	2026-01-26	Warnings	Exact identifier application number: M012
GOOD SENSE NIGHT TIME	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	L. Perrigo Company	cd68289b-3850-40c6-9439-aae0e2d7637d	2026-01-26	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V1Q0O9OJ9Z	CHLORPHENIRAMINE MALEATE	113-92-8	CHLORPHENIRAMINE MALEATE
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
998254	pseudoephedrine HCl 60 MG / chlorpheniramine maleate 4 MG Oral Tablet	PSN	7cd8f7f3-c262-4f7c-bcaf-068be2c952f9	22
998254	chlorpheniramine maleate 4 MG / pseudoephedrine hydrochloride 60 MG Oral Tablet	SCD	7cd8f7f3-c262-4f7c-bcaf-068be2c952f9	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-5351-24	00904535124	1 BLISTER PACK in 1 CARTON (0904-5351-24) / 24 TABLET in 1 BLISTER PACK	1 blister pack	1992-12-16	0000-00-00	No	No	Current
0904-5351-96	00904535196	2 BLISTER PACK in 1 CARTON (0904-5351-96) > 24 TABLET in 1 BLISTER PACK	2 blister pack	1992-12-16	2023-01-31	No	No	Current