SUDOGEST NASAL DECONGESTANT

Product NDC
50090-4345
11-digit product format
500904345
Labeler code
50090
Product ID
50090-4345_72064c3e-8348-4230-b2e3-47a03e3467df
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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
2026-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-434550090-4345-0DDiscontinued by firm2026-10-16
excluded packagepackage50090-434550090-4345-2DDiscontinued by firm2026-10-16
excluded packagepackage50090-434550090-4345-3DDiscontinued by firm2026-10-16
excluded packagepackage50090-434550090-4345-4DDiscontinued by firm2026-10-16
excluded packagepackage50090-434550090-4345-5DDiscontinued by firm2026-10-16

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 · 50 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0550090-4345-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0550090-4345-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0550090-4345-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0550090-4345-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0550090-4345-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2650090-4345-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2650090-4345-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2650090-4345-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2650090-4345-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2650090-4345-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3150090-4345-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3150090-4345-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3150090-4345-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3150090-4345-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3150090-4345-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2850090-4345-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2850090-4345-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2850090-4345-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2850090-4345-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2850090-4345-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2150090-4345-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2150090-4345-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2150090-4345-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2150090-4345-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2150090-4345-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1050090-4345-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1050090-4345-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1050090-4345-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1050090-4345-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1050090-4345-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3150090-4345-4302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3150090-4345-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3150090-4345-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3150090-4345-5302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3150090-4345-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2050090-4345-4ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2050090-4345-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2050090-4345-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2050090-4345-5ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2050090-4345-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1050090-4345-40efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1050090-4345-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1050090-4345-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1050090-4345-50efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1050090-4345-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0850090-4345-4ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0850090-4345-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0850090-4345-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0850090-4345-5ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0850090-4345-0ad56d346431e…cc804d4bbf1e…

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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6V9V2RYJ8NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049160Internal RxNorm lookup
1049162Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
09feb5f0-c22d-4a1b-97a0-d5767e5f7730Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4345-0SUDOGEST NASAL DECONGESTANT48 in 1 BOTTLETABLET, FILM COATED4810
50090-4345-1SUDOGEST NASAL DECONGESTANT1 in 1 BLISTER PACKTABLET, FILM COATED110
50090-4345-1SUDOGEST NASAL DECONGESTANT24 in 1 CARTONTABLET, FILM COATED2410
50090-4345-2SUDOGEST NASAL DECONGESTANT12 in 1 BOTTLETABLET, FILM COATED1210
50090-4345-3SUDOGEST NASAL DECONGESTANT30 in 1 BOTTLETABLET, FILM COATED3010
50090-4345-4SUDOGEST NASAL DECONGESTANT4 in 1 BOTTLETABLET, FILM COATED410
50090-4345-5SUDOGEST NASAL DECONGESTANT15 in 1 BOTTLETABLET, FILM COATED1510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4345-1EA - Each50090-4345a510bcc2-0b21-485b-b9e5-434600a4917112022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4345SUDOGEST NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 7 package rows20241109_09feb5f0-c22d-4a1b-97a0-d5767e5f7730.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 8 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sinus PE Head Congestion and MucusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLBetter Living Brands, LLC28a4ec37-11dd-4134-81aa-851f081bf0882026-08-17WarningsExact identifier
application number: M012
CVS Health No DripNASAL MISTCVS PHARMACY,INC.60ee7bd2-0d7c-4228-a559-0d5dbd3d44fa2026-08-17WarningsExact identifier
application number: M012
Daytime Cold and Cough and NightTime Cold and Congestion ChildrensBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWalgreens2bdc62b6-f3e1-4a79-9b29-00cc1d4280b32026-08-17WarningsExact identifier
application number: M012
CVS Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLCVS HEALTHf01ab8ef-d29a-4e33-8a14-4c57ccdcc0d62026-08-17WarningsExact identifier
application number: M012
Daytime NighttimeACETAMINOPHEN, GUAIFENESIN, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLKROGER COMPANY30d50bbe-0a14-c985-e063-6294a90a47b32026-08-16WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEARMY AND AIR FORCE EXCHANGE SERVICE77f87e19-a9d5-479d-9434-bbde13210bfb2026-08-15WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECardinal Health 110, LLC. DBA Leaderb1c2055b-4b5a-4fa2-b600-8930c9c8524c2026-08-15WarningsExact identifier
application number: M012
Nighttime HBP Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS PHARMACY146c9a62-0418-4b5d-9074-5be8a05f3f932026-08-15WarningsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader610accad-2f8b-4605-9357-a58e6e18d4172026-08-15WarningsExact identifier
application number: M012
Nasal Decongestant Maximum Strength, Non-DrowsyPSEUDOEPHEDRINE HCLAmerisource Bergen1fdb1ba5-4072-4baf-9e30-f01d57bf6d822026-08-15WarningsExact identifier
application number: M012
Cold and Flu NightACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreen Company32c67914-d7cf-40ee-8682-0ba8ed6912872026-08-15WarningsExact identifier
application number: M012
CVS Childrens COLD PLUS COUGH PLUS SORE THROATACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDECVS PHARMACY27820bce-6638-4f17-ac66-62b02b76bec32026-08-14WarningsExact identifier
application number: M012
CVS PHARMACY Childrens Cold and AllergyBROMPHENIRAMINE MALEATECVS PHARMACY, INC.004e104b-d6ff-48d5-8685-cd1bff45399a2026-08-14WarningsExact identifier
application number: M012
CHILDRENS DIMETAPP COLD AND COUGHBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS PHARMACY7babf4f6-ca0a-44a7-b1ea-d60e20d36f152026-08-14WarningsExact identifier
application number: M012
NasalOXYMETAZOLINE HYDROCHLORIDEAmazon.com Services LLCe7c8ffed-83b8-4088-b72c-d937e93f8b542026-08-14WarningsExact identifier
application number: M012
CVS Mucus Relief DM and Overnight Cold and FluDEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN AND TRIPROLIDINE HCLCVS75520b77-d40b-4f43-b92a-7a3eba5b493f2026-08-14WarningsExact identifier
application number: M012
CVS Severe Multi-Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS PHARMACYbb24c298-1d00-4378-8de3-b4056220fa752026-08-14WarningsExact identifier
application number: M012
SEVERE COLD PLUS FLU DAYTIME NIGHTTIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS Pharmacy,Inc.6cb1d08b-e544-4084-b9ed-1e0d99a709c82026-08-14Warnings, Adverse reactionsExact identifier
application number: M012
Theraflu Relief Max Strength DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY932a3d40-9b52-4e91-bc61-6fd506f2d9e62026-08-14WarningsExact identifier
application number: M012
Multi Symptom Severe Cold and Nighttime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS Pharmacy,Inc.91063edd-1e7e-41e9-8412-b14ef37490182026-08-14WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049160pseudoephedrine HCl 30 MG Oral TabletPSN09feb5f0-c22d-4a1b-97a0-d5767e5f773010
1049162SudoGest 30 MG Oral TabletPSN09feb5f0-c22d-4a1b-97a0-d5767e5f773010
1049162pseudoephedrine hydrochloride 30 MG Oral Tablet [Sudogest]SBD09feb5f0-c22d-4a1b-97a0-d5767e5f773010
1049160pseudoephedrine hydrochloride 30 MG Oral TabletSCD09feb5f0-c22d-4a1b-97a0-d5767e5f773010
1049162Sudogest 30 MG Oral TabletSY09feb5f0-c22d-4a1b-97a0-d5767e5f773010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4345-05009043450048 TABLET, FILM COATED in 1 BOTTLE (50090-4345-0) 2019-10-090000-00-00NoNoCurrent
50090-4345-15009043450124 BLISTER PACK in 1 CARTON (50090-4345-1) / 1 TABLET, FILM COATED in 1 BLISTER PACK24 blister pack2019-06-100000-00-00NoNoCurrent
50090-4345-25009043450212 TABLET, FILM COATED in 1 BOTTLE (50090-4345-2) 2019-10-090000-00-00NoNoCurrent
50090-4345-35009043450330 TABLET, FILM COATED in 1 BOTTLE (50090-4345-3) 2019-10-090000-00-00NoNoCurrent
50090-4345-4500904345044 TABLET, FILM COATED in 1 BOTTLE (50090-4345-4) 2019-10-090000-00-00NoNoCurrent
50090-4345-55009043450515 TABLET, FILM COATED in 1 BOTTLE (50090-4345-5) 2019-10-090000-00-00NoNoCurrent