FDA.reportPublic FDA data

Naproxen Sodium Diphenhydramine Hydrochloride

Product NDC
21130-814
11-digit product format
211300814
Labeler code
21130
Product ID
21130-814_463f13c5-0aeb-3fa5-e063-6394a90afe8c
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium Diphenhydramine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
SAFEWAY
Application
ANDA213663
Marketing category
ANDA
Marketing start
2023-06-30
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 Diphenhydramine Hydrochloride
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
21130-814-05Naproxen Sodium Diphenhydramine Hydrochloride50 in 1 BOTTLETABLET505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-814NAPROXEN SODIUM DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SAFEWAY]4Current NDC, 1 package rows20241212_ed0f3275-f156-13a3-e053-2a95a90a2ce8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1550957diphenhydrAMINE HCl 25 MG / naproxen sodium 220 MG Oral TabletPSNed0f3275-f156-13a3-e053-2a95a90a2ce85
1550957diphenhydramine hydrochloride 25 MG / naproxen sodium 220 MG Oral TabletSCDed0f3275-f156-13a3-e053-2a95a90a2ce85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21130-814-052113008140550 TABLET in 1 BOTTLE (21130-814-05) 50 tablet2023-06-30NoNoHistorical