SudoGest

Product NDC: 0904-5053
11-digit product format: 009045053
Labeler code: 0904
Product ID: 0904-5053_dea7c710-ba53-44d1-a05b-6254995679b8
Type: HUMAN OTC DRUG
Nonproprietary name: Pseudoephedrine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Major Pharmaceuticals
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1981-08-25
Substance: PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 30 mg/1
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], 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	0904-5053	0904-5053-24	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
PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
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
0904-5053-24	SudoGest	24 in 1 BLISTER PACK	TABLET, FILM COATED	24	25
0904-5053-24	SudoGest	1 in 1 CARTON	TABLET, FILM COATED	1	25
0904-5053-59	SudoGest	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	25
0904-5053-59	SudoGest	1 in 1 CARTON	TABLET, FILM COATED	1	25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-5053-24	EA - Each	0904-5053	5f294304-939e-4c0b-af84-6c0bb2f9bb11	1	2012-07-24
0904-5053-59	EA - Each	0904-5053	e6ec7cb2-becd-49b9-bed7-a75f6e1d8887	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	11
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	11
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	11
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	11
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	11
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	11
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	11
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	11
Pseudoephedrine Hydrochloride	ACTIVE INGREDIENT	6V9V2RYJ8N	SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
Pseudoephedrine	ACTIVE MOIETY	7CUC9DDI9F	SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
Croscarmellose Sodium	INACTIVE INGREDIENT	M28OL1HH48	SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
Polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
Triacetin	INACTIVE INGREDIENT	XHX3C3X673	SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET [A-S MEDICATION SOLUTIONS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-5053	SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	23	Current NDC, Legacy NDC, 4 package rows	20241113_d46577aa-7fd7-2130-6ed6-4b3f7562491f.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 94 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daytime Severe Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN, PHENYLEPHRINE HCL	Family Dollar (FAMILY WELLNESS)	17640528-c1f7-4881-ba86-bb3f488a952c	2025-10-24	Warnings	Exact identifier application number: M012
Vapor Stick	CAMPHOR/MENTHOL	China Ningbo Shangge Cosmetics Technology Corp.	33e259d6-b065-a677-e063-6394a90ab314	2025-10-23	Warnings	Exact identifier application number: M012
Severe Nighttime Severe Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS Pharmacy	1ec3fc79-4f38-439f-99be-646b82231aa5	2025-10-23	Warnings	Exact identifier application number: M012
Rycontuss	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Dextrum Laboratories, Inc	41afb883-1158-9764-e063-6294a90a1712	2025-10-21	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE	CVS Pharmacy, Inc	1532ee21-e114-ded7-e063-6294a90ab025	2025-10-21	Warnings	Exact identifier application number: M012
Guaifenesin and Dextromethorphan Hydrobromide	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	Method Pharmaceuticals	1538bf63-d020-3ba2-e063-6294a90aecc5	2025-10-21	Warnings	Exact identifier application number: M012
Guaifenesin and Dextromethorphan Hydrobromide	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	Method Pharmaceuticals	389230e5-775e-5b0d-e054-00144ff88e88	2025-10-21	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	Method Pharmaceuticals, LLC	1539c3d4-d982-7d4e-e063-6394a90ad7d6	2025-10-21	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	Method Pharmaceuticals, LLC	312ce620-4841-7488-e054-00144ff88e88	2025-10-21	Warnings	Exact identifier application number: M012
M-Dryl	DIPHENHYDRAMINE HYDROCHLORIDE	Method Pharmaceuticals, LLC	5a60c923-8bb7-427f-9636-08ed5474f71b	2025-10-21	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	97ed70a0-b692-4c12-90d6-72b3c87e554c	2025-10-21	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	311e2b6b-21cb-4b4c-a78d-a0732d29602f	2025-10-21	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	13910ea1-37dd-43bb-9fe8-e843f59201b7	2025-10-21	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Amerisource Bergen	d6f185b6-8538-4eac-98da-83760c34b488	2025-10-20	Warnings	Exact identifier application number: M012
Quantum Health Bing Cherry Flavor	MENTHOL, UNSPECIFIED FORM	Quantum, Inc.	94d40c95-fa2b-42cf-b9f5-a5027d86401d	2025-10-20	Warnings	Exact identifier application number: M012
Quantum Health Meyer Lemon and Honey Flavor	MENTHOL, UNSPECIFIED FORM	Quantum, Inc.	fe780067-5a20-4d55-a108-91237cd9e5f4	2025-10-20	Warnings	Exact identifier application number: M012
OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution (Cherry)	DIPHENHYDRAMINE HCL	MEDWISE LIFESCIENCES INC.	4157e680-37ac-eb4c-e063-6394a90a2a99	2025-10-17	Warnings	Exact identifier application number: M012
Norel AD	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCL	U.S. PHARMACEUTICAL CORPORATION	53d9ed3c-212d-4b12-ac35-8bd49382b49d	2025-10-17	Warnings	Exact identifier application number: M012
Severe Congestion, Cough, Cold and Flu Relief Maximum Strength, Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	92c570ff-139f-49ff-a7bd-8a540ecc07c7	2025-10-17	Warnings	Exact identifier application number: M012
NoHist DM	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	Larken Laboratories, Inc.	6aafe912-28ff-442f-8e07-b3c5993ac943	2025-10-16	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049160	pseudoephedrine HCl 30 MG Oral Tablet	PSN	d46577aa-7fd7-2130-6ed6-4b3f7562491f	25
1049162	SudoGest 30 MG Oral Tablet	PSN	d46577aa-7fd7-2130-6ed6-4b3f7562491f	25
1049162	pseudoephedrine hydrochloride 30 MG Oral Tablet [Sudogest]	SBD	d46577aa-7fd7-2130-6ed6-4b3f7562491f	25
1049160	pseudoephedrine hydrochloride 30 MG Oral Tablet	SCD	d46577aa-7fd7-2130-6ed6-4b3f7562491f	25
1049162	Sudogest 30 MG Oral Tablet	SY	d46577aa-7fd7-2130-6ed6-4b3f7562491f	25
1049160	pseudoephedrine HCl 30 MG Oral Tablet	PSN	1811199f-bf88-475f-8f94-b372db4bead3	13
1049162	SudoGest 30 MG Oral Tablet	PSN	1811199f-bf88-475f-8f94-b372db4bead3	13
1049162	pseudoephedrine hydrochloride 30 MG Oral Tablet [Sudogest]	SBD	1811199f-bf88-475f-8f94-b372db4bead3	13
1049160	pseudoephedrine hydrochloride 30 MG Oral Tablet	SCD	1811199f-bf88-475f-8f94-b372db4bead3	13
1049162	Sudogest 30 MG Oral Tablet	SY	1811199f-bf88-475f-8f94-b372db4bead3	13
1049160	pseudoephedrine HCl 30 MG Oral Tablet	PSN	2bedd920-8546-4019-964d-96c622fffc2e	10
1049162	SudoGest 30 MG Oral Tablet	PSN	2bedd920-8546-4019-964d-96c622fffc2e	10
1049162	pseudoephedrine hydrochloride 30 MG Oral Tablet [Sudogest]	SBD	2bedd920-8546-4019-964d-96c622fffc2e	10
1049160	pseudoephedrine hydrochloride 30 MG Oral Tablet	SCD	2bedd920-8546-4019-964d-96c622fffc2e	10
1049162	Sudogest 30 MG Oral Tablet	SY	2bedd920-8546-4019-964d-96c622fffc2e	10
1049160	pseudoephedrine HCl 30 MG Oral Tablet	PSN	656726ed-50cd-4f7e-8e51-e242afd1d9c9	1
1049162	SudoGest 30 MG Oral Tablet	PSN	656726ed-50cd-4f7e-8e51-e242afd1d9c9	1
1049162	pseudoephedrine hydrochloride 30 MG Oral Tablet [Sudogest]	SBD	656726ed-50cd-4f7e-8e51-e242afd1d9c9	1
1049160	pseudoephedrine hydrochloride 30 MG Oral Tablet	SCD	656726ed-50cd-4f7e-8e51-e242afd1d9c9	1
1049162	Sudogest 30 MG Oral Tablet	SY	656726ed-50cd-4f7e-8e51-e242afd1d9c9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-5053-24	00904505324	1 BLISTER PACK in 1 CARTON (0904-5053-24) > 24 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	1981-08-25	2021-11-11	No	No	Current
0904-5053-59	00904505359	1 BOTTLE, PLASTIC in 1 CARTON (0904-5053-59) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC		1981-08-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Major 44-112	Major Pharmaceuticals \| LNK International, Inc.	2026-10-06	HUMAN OTC DRUG LABEL	26
SUDOGEST	A-S Medication Solutions	2024-06-20	HUMAN OTC DRUG LABEL	13
Major 44-112	A-S Medication Solutions	2021-04-14	HUMAN OTC DRUG LABEL	10
Major 44-112	Proficient Rx LP	2019-10-01	HUMAN OTC DRUG LABEL	3
Major 44-112	REMEDYREPACK INC.	2019-02-01	HUMAN OTC DRUG LABEL	4
SudoGest Nasal Decongestant	Rebel Distributors Corp	2012-03-06	HUMAN OTC DRUG LABEL	1