SudoGest

Product NDC
0904-6338
Requested package NDC
0904-6338-60
11-digit product format
009046338
Labeler code
0904
Product ID
0904-6338_20f7a8e1-05a9-40a8-9198-9562452ddda0
Type
HUMAN OTC DRUG
Nonproprietary name
PSEUDOEPHEDRINE HCL
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-02-17
Marketing end
2021-12-21
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
30 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0904-63380904-6338-60DDiscontinued by firm2026-08-17

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NSUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, COATED [MAJOR PHARMACEUTICALS]2
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FSUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, COATED [MAJOR PHARMACEUTICALS]2
ACACIAINACTIVE INGREDIENT5C5403N26OSUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, COATED [MAJOR PHARMACEUTICALS]2
CALCIUM SULFATE ANHYDROUSINACTIVE INGREDIENTE934B3V59HSUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, COATED [MAJOR PHARMACEUTICALS]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, COATED [MAJOR PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, COATED [MAJOR PHARMACEUTICALS]2
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KSUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, COATED [MAJOR PHARMACEUTICALS]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, COATED [MAJOR PHARMACEUTICALS]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, COATED [MAJOR PHARMACEUTICALS]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, COATED [MAJOR PHARMACEUTICALS]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, COATED [MAJOR PHARMACEUTICALS]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, COATED [MAJOR PHARMACEUTICALS]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, COATED [MAJOR PHARMACEUTICALS]2
KAOLININACTIVE INGREDIENT24H4NWX5COSUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, COATED [MAJOR PHARMACEUTICALS]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQSUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, COATED [MAJOR PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, COATED [MAJOR PHARMACEUTICALS]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, COATED [MAJOR PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, COATED [MAJOR PHARMACEUTICALS]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, COATED [MAJOR PHARMACEUTICALS]2
SUCROSEINACTIVE INGREDIENTC151H8M554SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, COATED [MAJOR PHARMACEUTICALS]2
TALCINACTIVE INGREDIENT7SEV7J4R1USUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, COATED [MAJOR PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, COATED [MAJOR PHARMACEUTICALS]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049160pseudoephedrine HCl 30 MG Oral TabletPSN13cb7a7c-127b-4972-ab1c-565bc2286a5c7
1049162SudoGest 30 MG Oral TabletPSN13cb7a7c-127b-4972-ab1c-565bc2286a5c7
1049162pseudoephedrine hydrochloride 30 MG Oral Tablet [Sudogest]SBD13cb7a7c-127b-4972-ab1c-565bc2286a5c7
1049160pseudoephedrine hydrochloride 30 MG Oral TabletSCD13cb7a7c-127b-4972-ab1c-565bc2286a5c7
1049162Sudogest 30 MG Oral TabletSY13cb7a7c-127b-4972-ab1c-565bc2286a5c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0904-6338-6000904633860100 TABLET, COATED in 1 BOTTLE (0904-6338-60) 2014-02-172021-12-21NoNoCurrent