SudoGest Nasal Decongestant

Product NDC: 0904-6337
11-digit product format: 009046337
Labeler code: 0904
Product ID: 0904-6337_cb53d471-2671-44d5-9cf9-8ad734ee18e1
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: 1991-09-10
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

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 Nasal Decongestant
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049160	Internal RxNorm lookup
1049162	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
5229f4b2-a194-46f8-a0bc-4510fbe52075	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
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	Strength	SPL version
0904-6337-24	SudoGest Nasal Decongestant	2 in 1 CARTON	TABLET, FILM COATED	2		6
0904-6337-24	SudoGest Nasal Decongestant	12 in 1 BLISTER PACK	TABLET, FILM COATED	12		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6337-24	EA - Each	0904-6337	64127ff8-f200-4b9f-8e6e-4def259e8403	1	2019-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	SUDOGEST NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	SUDOGEST NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	SUDOGEST NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	SUDOGEST NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SUDOGEST NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SUDOGEST NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SUDOGEST NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SUDOGEST NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	SUDOGEST NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SUDOGEST NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SUDOGEST NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6337	SUDOGEST NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	5	Current NDC, Legacy NDC, 2 package rows	20240922_5229f4b2-a194-46f8-a0bc-4510fbe52075.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 11 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ORIGINAL Nasal PUMP MIST No Drip	OXYMETAZOLINE HYDROCHLORIDE	WinCo FOODS, LLC	ac27fd75-4fe4-433c-a434-2dac16c895c7	2026-08-07	Warnings	Exact identifier application number: M012
Winco Foods Childrens Allergy Relief Dye Free	DIPHENHYDRAMINE HYDROCHLORIDE	WINCO FOODS, LLC	a1367804-37c9-4906-858f-8feeb748d8d3	2026-08-07	Warnings	Exact identifier application number: M012
Severe Congestion Nasal Anti-Drip Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	WinCo FOODS, LLC	a09c2d02-334a-4840-b2d0-327121cec994	2026-08-07	Warnings	Exact identifier application number: M012
Daytime Nighttime Intense Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Walgreen Company	03aa43fd-4962-4c2c-9edd-e422a629a0e3	2026-08-06	Warnings	Exact identifier application number: M012
Allergy Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	f311b56f-b959-4070-9b23-82c642dd98b8	2026-08-06	Warnings	Exact identifier application number: M012
Cold Relief Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	L.N.K. International, Inc.	2ed25f69-89ef-4c50-946a-7e7b9df1ca8a	2026-08-06	Warnings	Exact identifier application number: M012
Eucamint	MENTHOL, CAMPHOR	Indiana Botanic Gardens	d79bc8de-9efb-4996-a55c-accda0f8edb2	2026-08-06	Warnings	Exact identifier application number: M012
NICOTINE GUM	NICOTINE POLACRILEX	Guangzhou Shuimu Jiahe Trading Co., Ltd.	4e88dab4-8e13-f074-e063-6394a90a3908	2026-08-06	Warnings	Exact identifier application number: M012
Oneoo Nicotine Gum (Mint)	NICOTINE POLACRILEX	Guangzhou Shuimu Jiahe Trading Co., Ltd.	54b1329b-b422-29a5-e063-6294a90a8780	2026-08-06	Warnings	Exact identifier application number: M012
Sine Aid PEAK MISERY	OXYMETAZOLINE HYDROCHLORIDE	Infirst Healthcare Inc.	586a2a14-7048-0c8b-e063-6394a90a65b7	2026-08-06	Warnings	Exact identifier application number: M012
DRX CHOICE Daytime and Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Raritan Pharmaceuticals Inc	b745f45d-2042-4daa-9932-241836d7734b	2026-08-06	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan HBr	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	NUVICARE LLC	6713fdff-0e4e-4a9d-b218-34f786339c57	2026-08-06	Warnings	Exact identifier application number: M012
Daytime Cold, Nighttime Cold multi-symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	3b462a5d-d48b-4b73-b5d4-d7944730bbdd	2026-08-06	Warnings	Exact identifier application number: M012
TOPCARE DAY TIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Topco Associates LLC	d1b89d17-b3b9-4133-88a3-8cd7c4efafa9	2026-08-05	Warnings	Exact identifier application number: M012
Sinufrin Quick Relief Decongestant	SINUFRIN	Neilmed pharmaceuticals Inc.	0c36a34e-462d-713c-e063-6294a90a1776	2026-08-05	Warnings	Exact identifier application number: M012
No Drip	OXYMETAZOLINE HYDROCHLORIDE	NeilMed Pharmaceuticals Inc	e9b799ad-9164-7f30-e053-2a95a90a00c5	2026-08-05	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Fast Dissolve	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	507284c3-cad9-d65c-e063-6394a90a58a8	2026-08-05	Warnings	Exact identifier application number: M012
cough and cold relief HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	United Natural Foods, Inc. dba UNFI	90482e7a-d7c7-4127-972d-5ee55e55ed1c	2026-08-04	Warnings	Exact identifier application number: M012
DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Walgreen Company	78edeb7a-4712-4f04-9d76-d5b2d20ce76d	2026-08-04	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Better Living Brands, LLC	33f34aa2-3b37-4e51-8428-4a12708aa064	2026-08-04	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	09feb5f0-c22d-4a1b-97a0-d5767e5f7730	10
1049162	SudoGest 30 MG Oral Tablet	PSN	09feb5f0-c22d-4a1b-97a0-d5767e5f7730	10
1049162	pseudoephedrine hydrochloride 30 MG Oral Tablet [Sudogest]	SBD	09feb5f0-c22d-4a1b-97a0-d5767e5f7730	10
1049160	pseudoephedrine hydrochloride 30 MG Oral Tablet	SCD	09feb5f0-c22d-4a1b-97a0-d5767e5f7730	10
1049162	Sudogest 30 MG Oral Tablet	SY	09feb5f0-c22d-4a1b-97a0-d5767e5f7730	10
1049160	pseudoephedrine HCl 30 MG Oral Tablet	PSN	5229f4b2-a194-46f8-a0bc-4510fbe52075	6
1049162	SudoGest 30 MG Oral Tablet	PSN	5229f4b2-a194-46f8-a0bc-4510fbe52075	6
1049162	pseudoephedrine hydrochloride 30 MG Oral Tablet [Sudogest]	SBD	5229f4b2-a194-46f8-a0bc-4510fbe52075	6
1049160	pseudoephedrine hydrochloride 30 MG Oral Tablet	SCD	5229f4b2-a194-46f8-a0bc-4510fbe52075	6
1049162	Sudogest 30 MG Oral Tablet	SY	5229f4b2-a194-46f8-a0bc-4510fbe52075	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6337-24	00904633724	2 BLISTER PACK in 1 CARTON (0904-6337-24) / 12 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	1991-09-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Major Pharmaceuticals SudoGest Drug Facts	Major Pharmaceuticals	2025-12-15	HUMAN OTC DRUG LABEL	6
SUDOGEST NASAL DECONGESTANT	A-S Medication Solutions	2024-11-07	HUMAN OTC DRUG LABEL	10