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 65 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
QUALITY CHOICE	COUGH DROPS VITAMIN C	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	23086723-5718-6d02-e063-6394a90a03d2	2025-12-29	Warnings	Exact identifier application number: M012
QUALITY CHOICE Cough Drops Creamy Strawberry	COUGH DROPS CREAMY STRAWBERRY	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	23085717-b2ee-175c-e063-6394a90a7f54	2025-12-29	Warnings	Exact identifier application number: M012
QUALITY CHOICE	COUGH DROPS MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2307bbe9-7c8f-4eff-e063-6394a90af4c3	2025-12-29	Warnings	Exact identifier application number: M012
Premier Value	COUGH DROPS CHERRY	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2a2de803-900d-02f4-e063-6394a90a84cc	2025-12-29	Warnings	Exact identifier application number: M012
QUALITY CHOICE	COUGH DROPS HONEY LEMON SUGAR FREE	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2307f3a7-f6e7-8a5d-e063-6394a90ab7eb	2025-12-29	Warnings	Exact identifier application number: M012
Premier Value	COUGH DROPS MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2a2e8fbe-c1c3-79b1-e063-6394a90a4d73	2025-12-29	Warnings	Exact identifier application number: M012
Premier Value	COUGH DROPS HONEY LEMON	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2a2dfcc3-e599-3102-e063-6394a90ad54a	2025-12-29	Warnings	Exact identifier application number: M012
Premier Value	COUGH DROPS BLACK CHERRY SUGAR FREE	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2a2ead3c-b4d5-ee8f-e063-6294a90a3c39	2025-12-29	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS CREAMY STRAWBERRY	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	29f42644-045b-c4b3-e063-6294a90a48fd	2025-12-29	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS VANILLA HONEY	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	29f45499-bf14-03e4-e063-6394a90a535c	2025-12-29	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS BLACK CHERRY SUGAR FREE	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	29f3ddcc-9d4e-f1b1-e063-6294a90ac86f	2025-12-29	Warnings	Exact identifier application number: M012
Menthol Flavor Cough Drop	MENTHOL FLAVOR COUGH DROP	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	274a5551-4989-d8fe-e063-6394a90aeabf	2025-12-29	Warnings	Exact identifier application number: M012
MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC Cough Drops	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	29f2acaa-2cc8-a999-e063-6294a90a15ce	2025-12-29	Warnings	Exact identifier application number: M012
Leader Throat Soothing Drops Creamy Strawberry	THROAT SOOTHING CREAMY STRAWBERRY	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	26a92ecc-6a9c-b569-e063-6394a90a8bcb	2025-12-29	Warnings	Exact identifier application number: M012
ValuMeds Allergy Relief Antihistamine Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health P.B.C.	a5ceab90-6885-4f3a-b001-97679e03c01b	2025-12-29	Warnings	Exact identifier application number: M012
Goodmeds Non-Drowsy Cough Relief	DEXTROMETHORPHAN HYDROBROMIDE	Cabinet Health P.B.C.	32482083-3f51-41f4-8d20-bedf143e066d	2025-12-29	Warnings	Exact identifier application number: M012
Tusnel EX	GUAIFENESIN	Llorens Pharmaceutical International Division, Inc.	77c16288-68c4-476c-995f-86f505663270	2025-12-29	Warnings	Exact identifier application number: M012
Tusnel DM	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Llorens Pharmaceutical International Division, Inc.	fe457e6d-422d-496c-bcb9-33594f3c42ff	2025-12-29	Warnings	Exact identifier application number: M012
Tusnel Diabetic	DEXTROMETHORPHAN, GUAIFENESIN	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	66b3c094-809e-4d2c-bc15-46563de685cb	2025-12-29	Warnings	Exact identifier application number: M012
Fortify	MENTHOL	Natures Formulae Health Products Ltd.	781d53cf-b3dc-3e2b-e053-2a91aa0a7dcd	2025-12-29	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