FDA.reportPublic FDA data

Sinus Congestion

Product NDC
83324-054
11-digit product format
833240054
Labeler code
83324
Product ID
83324-054_c5436fc7-acd2-40c8-9607-55fcb5406ee7
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chain Drug Marketing Association, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-07
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
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

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
83324-054-24Sinus Congestion24 in 1 BLISTER PACKTABLET, FILM COATED242
83324-054-24Sinus Congestion1 in 1 CARTONTABLET, FILM COATED12
83324-054-48Sinus Congestion2 in 1 CARTONTABLET, FILM COATED22
83324-054-48Sinus Congestion24 in 1 BLISTER PACKTABLET, FILM COATED242

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049160pseudoephedrine HCl 30 MG Oral TabletPSN9744d04d-298d-4acd-9470-db9e7f2901e72
1049160pseudoephedrine hydrochloride 30 MG Oral TabletSCD9744d04d-298d-4acd-9470-db9e7f2901e72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-054-24833240054241 BLISTER PACK in 1 CARTON (83324-054-24) / 24 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2025-11-07NoNoCurrent
83324-054-48833240054482 BLISTER PACK in 1 CARTON (83324-054-48) / 24 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2025-11-07NoNoCurrent