FDA.reportPublic FDA data

Naproxen Sodium and Diphenhydramine HCL

Product NDC
11673-819
11-digit product format
116730819
Labeler code
11673
Product ID
11673-819_46536f85-5a10-9ebe-e063-6394a90a97bd
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium and Diphenhydramine HCL
Dosage form
TABLET
Route
ORAL
Labeler
TARGET CORPORATION
Application
ANDA213663
Marketing category
ANDA
Marketing start
2024-03-01
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
Active strength
25; 220 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen Sodium and Diphenhydramine HCL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1
NAPROXEN SODIUM220 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40, 9TN87S3A3C
Rxcui1550957

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-819-08Naproxen Sodium and Diphenhydramine HCL80 in 1 BOTTLETABLET806

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-819NAPROXEN SODIUM AND DIPHENHYDRAMINE HCL TABLET [TARGET CORPORATION]4Current NDC, 1 package rows20241120_fe82699d-fdc2-038e-e053-6294a90a606c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1550957diphenhydrAMINE HCl 25 MG / naproxen sodium 220 MG Oral TabletPSNfe82699d-fdc2-038e-e053-6294a90a606c6
1550957diphenhydramine hydrochloride 25 MG / naproxen sodium 220 MG Oral TabletSCDfe82699d-fdc2-038e-e053-6294a90a606c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11673-819-081167308190880 TABLET in 1 BOTTLE (11673-819-08) 80 tablet2024-03-01NoNoHistorical