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
2026-12-31
Current FDA listing
Yes

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 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
0904-6337-24SudoGest Nasal Decongestant2 in 1 CARTONTABLET, FILM COATED26
0904-6337-24SudoGest Nasal Decongestant12 in 1 BLISTER PACKTABLET, FILM COATED126

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6337-24EA - Each0904-633764127ff8-f200-4b9f-8e6e-4def259e840312019-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NSUDOGEST NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FSUDOGEST NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPSUDOGEST NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSUDOGEST NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUDOGEST NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSUDOGEST NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUDOGEST NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASUDOGEST NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSUDOGEST NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SUDOGEST NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSUDOGEST NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6337SUDOGEST NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5Current NDC, Legacy NDC, 2 package rows20240922_5229f4b2-a194-46f8-a0bc-4510fbe52075.zip

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
1049160pseudoephedrine HCl 30 MG Oral TabletPSN5229f4b2-a194-46f8-a0bc-4510fbe520756
1049162SudoGest 30 MG Oral TabletPSN5229f4b2-a194-46f8-a0bc-4510fbe520756
1049162pseudoephedrine hydrochloride 30 MG Oral Tablet [Sudogest]SBD5229f4b2-a194-46f8-a0bc-4510fbe520756
1049160pseudoephedrine hydrochloride 30 MG Oral TabletSCD5229f4b2-a194-46f8-a0bc-4510fbe520756
1049162Sudogest 30 MG Oral TabletSY5229f4b2-a194-46f8-a0bc-4510fbe520756

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6337-24009046337242 BLISTER PACK in 1 CARTON (0904-6337-24) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack1991-09-100000-00-00NoNoCurrent