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 102 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AXIV NightTime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	VIVUNT PHARMA LLC	131f6314-c9a1-7af3-e063-6294a90abe6f	2025-09-17	Warnings	Exact identifier application number: M012
AXIV DayTime - NightTime 48 Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	VIVUNT PHARMA LLC	1320e243-344f-98ed-e063-6294a90a0092	2025-09-17	Warnings	Exact identifier application number: M012
AXIV Sinus Severe Mucus	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCLORIDE	VIVUNT PHARMA LLC	13245298-8b78-e177-e063-6294a90a6bec	2025-09-17	Warnings	Exact identifier application number: M012
GoodSense Tussin CF Multi-Symptom Cold, Raspberry	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Geiss, Destin & Dunn Inc.	3f05cf84-d485-7688-e063-6394a90ae740	2025-09-17	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Family Dollar (FAMILY WELLNESS)	5d7466b4-fdb7-432b-880d-e7aa4a4acbda	2025-09-17	Warnings	Exact identifier application number: M012
allergy relief Childrens	DIPHENHYDRAMINE HCL	United Natural Foods, Inc. dba UNFI	e34d8bf5-e12e-453c-93ea-9c7988c4f13d	2025-09-16	Warnings	Exact identifier application number: M012
DayTime Cold Flu Non Drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Harris Teeter, LLC	67beb9f6-4e0a-4f7b-b50a-4bcd3a01354f	2025-09-16	Warnings	Exact identifier application number: M012
DOMETUSS	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Domel Laboratories	3ebfc62f-27f6-48b2-9bae-bdefbd1d05fe	2025-09-16	Warnings	Exact identifier application number: M012
CareOne Severe Congestion Nasal	OXYMETAZOLINE HYDROCHLORIDE	American Sales Company	d1dba68b-c4e1-4afc-9aee-6a51341b89f5	2025-09-16	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	FSA Store Inc. (Caring Mills)	e69ef8dc-09d2-46de-aebf-ba735f4cc7ea	2025-09-16	Warnings	Exact identifier application number: M012
Menthol Cough Drops Honey Lemon Flavor	MENTHOL HONEY LEMON FLAVOR	CVS Pharmacy	3ea9a1f2-75b3-c67a-e063-6294a90a8caf	2025-09-13	Warnings	Exact identifier application number: M012
Menthol Cough Drops Honey Lemon Flavor	MENTHOL HONEY LEMON FLAVOR	CVS Pharmacy	3eab4cf9-6fdc-a6fb-e063-6394a90a8633	2025-09-13	Warnings	Exact identifier application number: M012
COLD AND FLU DAYTIME-NIGHTTIME	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	TARGET CORP	9de9fab3-890a-158d-e053-2a95a90af423	2025-09-13	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Precision Dose, Inc.	4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea4	2025-09-12	Warnings	Exact identifier application number: M012
Nasal Spray, Circle K	OXYMETAZOLINE HYDROCHLORIDE 0.05% SOLUTION	Lil' Drug Store Products, Inc.	3ea06e88-a2c6-621b-e063-6294a90a1075	2025-09-12	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Harris Teeter, LLC	a0090dc6-0fe5-4ab2-a2cf-6ed19892f363	2025-09-12	Warnings	Exact identifier application number: M012
Multi Symptom Cold and Multi Symptom Nighttime Cold Childrens	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI	CVS Pharmacy	ebf2dbb4-96fa-4bf6-9afd-8aa8b5369f2e	2025-09-12	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	FSA Store Inc. (Caring Mills)	8d7bb31b-a47d-4252-a0a7-79d286179fb9	2025-09-12	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Family Dollar (FAMILY WELLNESS)	150e5c3a-7c86-4b66-af30-a376df697401	2025-09-12	Warnings	Exact identifier application number: M012
SEVERE COUGH COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	67f8d405-a2ad-4ade-93b4-9b09a0d81d8e	2025-09-11	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