FDA.reportPublic FDA data

All Day Sinus and Cold D

Product NDC
0363-0650
11-digit product format
003630650
Labeler code
0363
Product ID
0363-0650_fe8734c6-b6c7-44c6-bdc7-a6e093f24957
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen sodium, Pseudoephedrine HCl
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Walgreen Company
Application
ANDA076518
Marketing category
ANDA
Marketing start
2013-05-23
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
All Day 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
0363-0650-01All Day Sinus and Cold D1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE110
0363-0650-01All Day Sinus and Cold D20 in 1 CARTONTABLET, FILM COATED, EXTENDED RE2010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0650-01EA - Each0363-0650f801ce78-99cf-4ded-a03e-3c04a33a3e8912022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CALL DAY SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [WALGREEN COMPANY]2
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NALL DAY SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [WALGREEN COMPANY]2
NAPROXENACTIVE MOIETY57Y76R9ATQALL DAY SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [WALGREEN COMPANY]2
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FALL DAY SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [WALGREEN COMPANY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALL DAY SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [WALGREEN COMPANY]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALL DAY SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [WALGREEN COMPANY]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALL DAY SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [WALGREEN COMPANY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALL DAY SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [WALGREEN COMPANY]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALL DAY SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [WALGREEN COMPANY]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HALL DAY SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [WALGREEN COMPANY]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EALL DAY SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [WALGREEN COMPANY]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALL DAY SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [WALGREEN COMPANY]2
TALCINACTIVE INGREDIENT7SEV7J4R1UALL DAY SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [WALGREEN COMPANY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALL DAY SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [WALGREEN COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0650ALL DAY SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED, EXTENDED RELEASE [WALGREEN COMPANY]10Current NDC, Legacy NDC, 2 package rows20250429_b0417ce5-3a5e-42cb-8672-9f2b133c91ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1367426naproxen sodium 220 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSNb0417ce5-3a5e-42cb-8672-9f2b133c91ca10
136742612 HR naproxen sodium 220 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCDb0417ce5-3a5e-42cb-8672-9f2b133c91ca10
1367426naproxen sodium 220 MG / pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Oral TabletSYb0417ce5-3a5e-42cb-8672-9f2b133c91ca10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0650-010036306500120 BLISTER PACK in 1 CARTON (0363-0650-01) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK20 blister pack2013-05-230000-00-00NoNoCurrent