FDA.reportPublic FDA data

Sinus and Cold D

Product NDC
51316-339
11-digit product format
513160339
Labeler code
51316
Product ID
51316-339_eaa50625-231f-4b50-8831-e0f57bdbfaff
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen sodium, Pseudoephedrine hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application
ANDA076518
Marketing category
ANDA
Marketing start
2024-05-08
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
Sinus and Cold D
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
51316-339-01Sinus and Cold D20 in 1 CARTONTABLET, FILM COATED, EXTENDED RE203
51316-339-01Sinus and Cold D1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-339SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]3Current NDC, 2 package rows20240711_9e142ac7-c8b1-449b-a224-c7db0fc0e4cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1367426naproxen sodium 220 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN9e142ac7-c8b1-449b-a224-c7db0fc0e4cf3
136742612 HR naproxen sodium 220 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD9e142ac7-c8b1-449b-a224-c7db0fc0e4cf3
1367426naproxen sodium 220 MG / pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Oral TabletSY9e142ac7-c8b1-449b-a224-c7db0fc0e4cf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-339-015131603390120 BLISTER PACK in 1 CARTON (51316-339-01) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK20 blister pack2024-05-08NoNoCurrent