FDA.reportPublic FDA data

naproxen sodium pm

Product NDC
37808-264
11-digit product format
378080264
Labeler code
37808
Product ID
37808-264_7f8e2c7c-648d-488d-bd75-b9f353ce0424
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine hydrochloride, naproxen sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H E B
Application
ANDA208499
Marketing category
ANDA
Marketing start
2020-10-13
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
naproxen sodium pm
Listing expiration
2027-12-31

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
37808-264-27naproxen sodium pm80 in 1 BOTTLETABLET, FILM COATED805
37808-264-27naproxen sodium pm1 in 1 CARTONTABLET, FILM COATED15
37808-264-60naproxen sodium pm20 in 1 BOTTLETABLET, FILM COATED205
37808-264-60naproxen sodium pm1 in 1 CARTONTABLET, FILM COATED15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-264NAPROXEN SODIUM PM (DIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUM) TABLET, FILM COATED [H E B]4Current NDC, Legacy NDC, 4 package rows20240201_4281faf5-7182-404f-9f53-3d9ea0354a18.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1550957diphenhydrAMINE HCl 25 MG / naproxen sodium 220 MG Oral TabletPSN4281faf5-7182-404f-9f53-3d9ea0354a185
1550957diphenhydramine hydrochloride 25 MG / naproxen sodium 220 MG Oral TabletSCD4281faf5-7182-404f-9f53-3d9ea0354a185

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-264-27378080264271 BOTTLE in 1 CARTON (37808-264-27) / 80 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-10-130000-00-00NoNoCurrent
37808-264-60378080264601 BOTTLE in 1 CARTON (37808-264-60) / 20 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-10-130000-00-00NoNoCurrent