FDA.reportPublic FDA data

SUDAFED Sinus Congestion

Product NDC
50580-363
11-digit product format
505800363
Labeler code
50580
Product ID
50580-363_21707bfd-d78e-0f04-e063-6294a90a8945
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Kenvue Brands LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-07-31
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
SUDAFED Sinus Congestion
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6V9V2RYJ8N
Rxcui1049160, 1049529

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
50580-363-01SUDAFED Sinus Congestion4 in 1 CARTONTABLET, FILM COATED47
50580-363-01SUDAFED Sinus Congestion12 in 1 BLISTER PACKTABLET, FILM COATED127
50580-363-02SUDAFED Sinus Congestion12 in 1 BLISTER PACKTABLET, FILM COATED127
50580-363-02SUDAFED Sinus Congestion2 in 1 CARTONTABLET, FILM COATED27
50580-363-03SUDAFED Sinus Congestion2 in 1 CARTONTABLET, FILM COATED27
50580-363-03SUDAFED Sinus Congestion3 in 1 PACKAGETABLET, FILM COATED37

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-363-02EA - Each50580-36301e83130-ad41-475c-b75e-e12f17e0c78b12024-04-05
50580-363-03EA - Each50580-3639dff6b70-befc-48c0-bd65-f01ec7b83b4d12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-363SUDAFED SINUS CONGESTION (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [KENVUE BRANDS LLC]7Current NDC, Legacy NDC, 6 package rows20241109_c05d7e27-6821-468f-b27d-9c0b02a07b0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049160pseudoephedrine HCl 30 MG Oral TabletPSNc05d7e27-6821-468f-b27d-9c0b02a07b0f7
1049529SUDAFED 30 MG Oral TabletPSNc05d7e27-6821-468f-b27d-9c0b02a07b0f7
1049529pseudoephedrine hydrochloride 30 MG Oral Tablet [Sudafed]SBDc05d7e27-6821-468f-b27d-9c0b02a07b0f7
1049160pseudoephedrine hydrochloride 30 MG Oral TabletSCDc05d7e27-6821-468f-b27d-9c0b02a07b0f7
1049529Sudafed 30 MG Oral TabletSYc05d7e27-6821-468f-b27d-9c0b02a07b0f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-363-01505800363014 BLISTER PACK in 1 CARTON (50580-363-01) / 12 TABLET, FILM COATED in 1 BLISTER PACK4 blister pack2021-07-310000-00-00NoNoCurrent
50580-363-02505800363022 BLISTER PACK in 1 CARTON (50580-363-02) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2021-07-310000-00-00NoNoCurrent
50580-363-03505800363033 CARTON in 1 PACKAGE (50580-363-03) / 2 BLISTER PACK in 1 CARTON / 12 TABLET, FILM COATED in 1 BLISTER PACK3 carton2022-02-070000-00-00NoNoCurrent