FDA.reportPublic FDA data

dg health naproxen sodium pm

Product NDC
55910-858
11-digit product format
559100858
Labeler code
55910
Product ID
55910-858_97174bfd-34aa-43d1-ae4d-0b4993d32954
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine hydrochloride, naproxen sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dolgencorp Inc
Application
ANDA208499
Marketing category
ANDA
Marketing start
2020-07-10
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
dg health naproxen sodium pm
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
55910-858-27dg health naproxen sodium pm80 in 1 BOTTLETABLET, FILM COATED804
55910-858-27dg health naproxen sodium pm1 in 1 CARTONTABLET, FILM COATED14
55910-858-58dg health naproxen sodium pm40 in 1 BOTTLETABLET, FILM COATED404
55910-858-58dg health naproxen sodium pm1 in 1 CARTONTABLET, FILM COATED14
55910-858-60dg health naproxen sodium pm20 in 1 BOTTLETABLET, FILM COATED204
55910-858-60dg health naproxen sodium pm1 in 1 CARTONTABLET, FILM COATED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-858DG HEALTH NAPROXEN SODIUM PM (DIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUM) TABLET, FILM COATED [DOLGENCORP INC]3Current NDC, Legacy NDC, 6 package rows20240308_6c2c087c-e36d-4971-b977-d3cab6d6edee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1550957diphenhydrAMINE HCl 25 MG / naproxen sodium 220 MG Oral TabletPSN6c2c087c-e36d-4971-b977-d3cab6d6edee4
1550957diphenhydramine hydrochloride 25 MG / naproxen sodium 220 MG Oral TabletSCD6c2c087c-e36d-4971-b977-d3cab6d6edee4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-858-27559100858271 BOTTLE in 1 CARTON (55910-858-27) / 80 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-07-100000-00-00NoNoCurrent
55910-858-58559100858581 BOTTLE in 1 CARTON (55910-858-58) > 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-07-130000-00-00NoNoCurrent
55910-858-60559100858601 BOTTLE in 1 CARTON (55910-858-60) > 20 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-07-130000-00-00NoNoCurrent