Aleve-D Sinus and Cold

Product NDC
0280-6090
11-digit product format
002806090
Labeler code
0280
Product ID
0280-6090_4526c387-9c6e-1a47-e063-6394a90a21da
Type
HUMAN OTC DRUG
Nonproprietary name
naproxen sodium, pseudeoephedrine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
ANDA076518
Marketing category
ANDA
Marketing start
2014-01-01
Substance
NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
220; 120 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], 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
Aleve-D Sinus and Cold
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM220 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C, 6V9V2RYJ8N
Rxcui1367426

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
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
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-6090-10Aleve-D Sinus and Cold10 in 1 BLISTER PACKTABLET108
0280-6090-10Aleve-D Sinus and Cold1 in 1 CARTONTABLET18
0280-6090-20Aleve-D Sinus and Cold10 in 1 BLISTER PACKTABLET108
0280-6090-20Aleve-D Sinus and Cold2 in 1 CARTONTABLET28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0280-6090-10EA - Each0280-609018dd7189-618f-4f5c-90fa-15c586f65fe012018-11-06
0280-6090-20EA - Each0280-6090dfd25e28-db27-4582-be80-d137007f164f12017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-6090ALEVE-D SINUS AND COLD (NAPROXEN SODIUM, PSEUDEOEPHEDRINE HYDROCHLORIDE) TABLET [BAYER HEALTHCARE LLC.]7Current NDC, Legacy NDC, 4 package rows20241208_599ea6c8-03ad-536e-e053-2991aa0a83a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1367426naproxen sodium 220 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN599ea6c8-03ad-536e-e053-2991aa0a83a38
136742612 HR naproxen sodium 220 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD599ea6c8-03ad-536e-e053-2991aa0a83a38
1367426naproxen sodium 220 MG / pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Oral TabletSY599ea6c8-03ad-536e-e053-2991aa0a83a38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0280-6090-10002806090101 BLISTER PACK in 1 CARTON (0280-6090-10) / 10 TABLET in 1 BLISTER PACK1 blister pack2014-01-010000-00-00NoNoCurrent
0280-6090-20002806090202 BLISTER PACK in 1 CARTON (0280-6090-20) / 10 TABLET in 1 BLISTER PACK2 blister pack2014-01-010000-00-00NoNoCurrent