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		2026-10-21

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 60 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	e07931fc-f753-1aeb-e053-2a95a90ada3f	2026-01-08	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night	ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	fc60af2f-83cb-99ea-e053-6394a90a0b3b	2026-01-08	Warnings	Exact identifier application number: M012
Alka Seltzer Plus Maximum Strength Sinus, Allergy And Cough Power Max Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	e17eb929-209d-a2d1-e053-2a95a90a4cf3	2026-01-08	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold Night PowerFast Fizz	ASPIRIN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	c1fae6c7-bbac-1320-e053-2a95a90aac5a	2026-01-08	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Night Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	f4c60ca1-ba59-4a92-84a5-6ba65faa56ab	2026-01-08	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Day Severe Cold Plus Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	cec51eab-cce3-4965-a14e-a46d953050c4	2026-01-08	Warnings	Exact identifier application number: M012
VanaCof 2	CHLOPHEDIANOL HCL, DEXCHLORPHENIRAMINE MALEATE	GM Pharmaceuticals, INC	0c7c6756-abb2-c10c-e063-6394a90a9863	2026-01-08	Warnings	Exact identifier application number: M012
VANACOF XP Cough / Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	GM Pharmaceuticals, INC	0b3a8cc1-a49f-e1e5-e063-6394a90a1c06	2026-01-08	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HCL	INVAHEALTH INC	e4e4004f-77e3-569d-e053-2a95a90a73fe	2026-01-08	Warnings	Exact identifier application number: M012
Robitussin Maximum Strength Cough Plus Chest Congestion DM	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Haleon US Holdings LLC	868ac65a-63e2-46ac-b87d-66b289086756	2026-01-08	Warnings	Exact identifier application number: M012
Theraflu Flu Relief Max Strength Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	0324195f-506d-4747-990e-ad44e2a117d9	2026-01-07	Warnings	Exact identifier application number: M012
Sambrosa Night	DOXYLAMINE SUCCINATE	Sambrosa Care, Inc.	acdc8740-6231-d1e8-e053-2995a90a3b8d	2026-01-07	Warnings	Exact identifier application number: M012
VAPOREX	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	DLC Laboratories, Inc.	971943b1-4199-4f75-9d2d-61242d346b5f	2026-01-07	Warnings	Exact identifier application number: M012
BACTIMICINA COUGH AND COLD	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DLC Laboratories, Inc.	2e612c62-9bbb-45f2-a253-aa2bfaeaac70	2026-01-07	Warnings	Exact identifier application number: M012
Earths Care Chest Rub	CAMPHOR, EUCALYPTUS OI, MENTHOL	DLC Laboratories, Inc	2424f5d5-1772-96f1-e063-6294a90a89ee	2026-01-07	Warnings	Exact identifier application number: M012
Bactimicina Vapor Rub	VAPOR RUB	DLC Laboratories, Inc.	176b617a-faf6-7893-e063-6294a90a046b	2026-01-07	Warnings	Exact identifier application number: M012
Sinus Pressure and Pain	ACETAMINOPHEN, PHENYLEPHRINE HCL	Family Dollar Services Inc	0d3e4ceb-5059-4aac-8aa2-bf714ca9deb2	2026-01-07	Warnings	Exact identifier application number: M012
Tussin Multi Symptom Cold CF	DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL	QUALITY CHOICE (Chain Drug Marketing Association)	b225e897-5728-4519-b727-c0f361c75976	2026-01-07	Warnings	Exact identifier application number: M012
Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreen Company	80b218f7-66bb-4e15-a0dc-ec9b6af1b056	2026-01-07	Warnings	Exact identifier application number: M012
tussin cough and chest congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Rite Aid Corporation	13618054-d0c5-4190-b626-e7e91b855738	2026-01-06	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