FDA.reportPublic FDA data

SudoGest

Product NDC
0904-5053
11-digit product format
009045053
Labeler code
0904
Product ID
0904-5053_a5e06aa8-2ce0-4c33-9911-cc2f4532d173
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SudoGest
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6V9V2RYJ8N
Rxcui1049160, 1049162

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-5053-24SudoGest24 in 1 BLISTER PACKTABLET, FILM COATED2425
0904-5053-24SudoGest1 in 1 CARTONTABLET, FILM COATED125
0904-5053-59SudoGest100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10025
0904-5053-59SudoGest1 in 1 CARTONTABLET, FILM COATED125

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5053-24EA - Each0904-50535f294304-939e-4c0b-af84-6c0bb2f9bb1112012-07-24
0904-5053-59EA - Each0904-5053e6ec7cb2-becd-49b9-bed7-a75f6e1d888712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NSUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]11
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FSUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]11
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]11
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]11
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]11
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IESUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]11
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]11
TRIACETININACTIVE INGREDIENTXHX3C3X673SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]11
Pseudoephedrine HydrochlorideACTIVE INGREDIENT6V9V2RYJ8NSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NSUDOGEST (PSEUDOEPHEDRINE HCL) TABLET [A-S MEDICATION SOLUTIONS LLC]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FSUDOGEST (PSEUDOEPHEDRINE HCL) TABLET [A-S MEDICATION SOLUTIONS LLC]1
PseudoephedrineACTIVE MOIETY7CUC9DDI9FSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET [A-S MEDICATION SOLUTIONS LLC]1
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET [A-S MEDICATION SOLUTIONS LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSUDOGEST (PSEUDOEPHEDRINE HCL) TABLET [A-S MEDICATION SOLUTIONS LLC]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET [A-S MEDICATION SOLUTIONS LLC]1
PolydextroseINACTIVE INGREDIENTVH2XOU12IESUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IESUDOGEST (PSEUDOEPHEDRINE HCL) TABLET [A-S MEDICATION SOLUTIONS LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASUDOGEST (PSEUDOEPHEDRINE HCL) TABLET [A-S MEDICATION SOLUTIONS LLC]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSUDOGEST (PSEUDOEPHEDRINE HCL) TABLET [A-S MEDICATION SOLUTIONS LLC]1
TriacetinINACTIVE INGREDIENTXHX3C3X673SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
TRIACETININACTIVE INGREDIENTXHX3C3X673SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET [A-S MEDICATION SOLUTIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-5053SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]23Current NDC, Legacy NDC, 4 package rows20241113_d46577aa-7fd7-2130-6ed6-4b3f7562491f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049160pseudoephedrine HCl 30 MG Oral TabletPSNd46577aa-7fd7-2130-6ed6-4b3f7562491f25
1049162SudoGest 30 MG Oral TabletPSNd46577aa-7fd7-2130-6ed6-4b3f7562491f25
1049162pseudoephedrine hydrochloride 30 MG Oral Tablet [Sudogest]SBDd46577aa-7fd7-2130-6ed6-4b3f7562491f25
1049160pseudoephedrine hydrochloride 30 MG Oral TabletSCDd46577aa-7fd7-2130-6ed6-4b3f7562491f25
1049162Sudogest 30 MG Oral TabletSYd46577aa-7fd7-2130-6ed6-4b3f7562491f25
1049160pseudoephedrine HCl 30 MG Oral TabletPSN1811199f-bf88-475f-8f94-b372db4bead313
1049162SudoGest 30 MG Oral TabletPSN1811199f-bf88-475f-8f94-b372db4bead313
1049162pseudoephedrine hydrochloride 30 MG Oral Tablet [Sudogest]SBD1811199f-bf88-475f-8f94-b372db4bead313
1049160pseudoephedrine hydrochloride 30 MG Oral TabletSCD1811199f-bf88-475f-8f94-b372db4bead313
1049162Sudogest 30 MG Oral TabletSY1811199f-bf88-475f-8f94-b372db4bead313
1049160pseudoephedrine HCl 30 MG Oral TabletPSN2bedd920-8546-4019-964d-96c622fffc2e10
1049162SudoGest 30 MG Oral TabletPSN2bedd920-8546-4019-964d-96c622fffc2e10
1049162pseudoephedrine hydrochloride 30 MG Oral Tablet [Sudogest]SBD2bedd920-8546-4019-964d-96c622fffc2e10
1049160pseudoephedrine hydrochloride 30 MG Oral TabletSCD2bedd920-8546-4019-964d-96c622fffc2e10
1049162Sudogest 30 MG Oral TabletSY2bedd920-8546-4019-964d-96c622fffc2e10
1049160pseudoephedrine HCl 30 MG Oral TabletPSN656726ed-50cd-4f7e-8e51-e242afd1d9c91
1049162SudoGest 30 MG Oral TabletPSN656726ed-50cd-4f7e-8e51-e242afd1d9c91
1049162pseudoephedrine hydrochloride 30 MG Oral Tablet [Sudogest]SBD656726ed-50cd-4f7e-8e51-e242afd1d9c91
1049160pseudoephedrine hydrochloride 30 MG Oral TabletSCD656726ed-50cd-4f7e-8e51-e242afd1d9c91
1049162Sudogest 30 MG Oral TabletSY656726ed-50cd-4f7e-8e51-e242afd1d9c91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-5053-24009045053241 BLISTER PACK in 1 CARTON (0904-5053-24) > 24 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack1981-08-252021-11-11NoNoCurrent
0904-5053-59009045053591 BOTTLE, PLASTIC in 1 CARTON (0904-5053-59) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1981-08-250000-00-00NoNoCurrent