FDA.reportPublic FDA data

Aleve PM

Product NDC
0280-1200
11-digit product format
002801200
Labeler code
0280
Product ID
0280-1200_45265ccc-d985-a6ad-e063-6394a90a75b7
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
NDA205352
Marketing category
NDA
Marketing start
2014-09-09
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
Aleve 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, 1550963

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
0280-1200-01Aleve PM120 in 1 BOTTLETABLET, FILM COATED12016
0280-1200-01Aleve PM1 in 1 CARTONTABLET, FILM COATED116
0280-1200-02Aleve PM2 in 1 POUCHTABLET, FILM COATED216
0280-1200-03Aleve PM160 in 1 BOTTLETABLET, FILM COATED16016
0280-1200-04Aleve PM1 in 1 CARTONTABLET, FILM COATED116
0280-1200-04Aleve PM40 in 1 BOTTLETABLET, FILM COATED4016
0280-1200-05Aleve PM80 in 1 BOTTLETABLET, FILM COATED8016
0280-1200-08Aleve PM250 in 1 BOTTLETABLET, FILM COATED25016
0280-1200-08Aleve PM1 in 1 CARTONTABLET, FILM COATED116
0280-1200-20Aleve PM1 in 1 CARTONTABLET, FILM COATED116
0280-1200-20Aleve PM20 in 1 BOTTLETABLET, FILM COATED2016
0280-1200-40Aleve PM1 in 1 CARTONTABLET, FILM COATED116
0280-1200-40Aleve PM40 in 1 BOTTLETABLET, FILM COATED4016
0280-1200-80Aleve PM80 in 1 BOTTLETABLET, FILM COATED8016
0280-1200-80Aleve PM1 in 1 CARTONTABLET, FILM COATED116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0280-1200-08EA - Each0280-12007162e0ff-5f6c-4faf-9e4b-d504cff9c3bb12025-05-14
0280-1200-20EA - Each0280-1200212e63c7-774e-4441-ab13-a909fe2f7d9a12025-05-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM) TABLET, FILM COATED [BAYER HEALTHCARE CONSUMER CARE]1
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM) TABLET, FILM COATED [BAYER HEALTHCARE CONSUMER CARE]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM) TABLET, FILM COATED [BAYER HEALTHCARE CONSUMER CARE]1
NAPROXENACTIVE MOIETY57Y76R9ATQALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM) TABLET, FILM COATED [BAYER HEALTHCARE CONSUMER CARE]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM) TABLET, FILM COATED [BAYER HEALTHCARE CONSUMER CARE]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM) TABLET, FILM COATED [BAYER HEALTHCARE CONSUMER CARE]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM) TABLET, FILM COATED [BAYER HEALTHCARE CONSUMER CARE]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM) TABLET, FILM COATED [BAYER HEALTHCARE CONSUMER CARE]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM) TABLET, FILM COATED [BAYER HEALTHCARE CONSUMER CARE]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM) TABLET, FILM COATED [BAYER HEALTHCARE CONSUMER CARE]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM) TABLET, FILM COATED [BAYER HEALTHCARE CONSUMER CARE]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM) TABLET, FILM COATED [BAYER HEALTHCARE CONSUMER CARE]1
TALCINACTIVE INGREDIENT7SEV7J4R1UALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM) TABLET, FILM COATED [BAYER HEALTHCARE CONSUMER CARE]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM) TABLET, FILM COATED [BAYER HEALTHCARE CONSUMER CARE]1
WATERINACTIVE INGREDIENT059QF0KO0RALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM) TABLET, FILM COATED [BAYER HEALTHCARE CONSUMER CARE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-1200ALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM) TABLET, FILM COATED [BAYER HEALTHCARE LLC.]15Current NDC, Legacy NDC, 15 package rows20241210_82891458-ab0d-459a-8602-dcebd22c3010.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1550963Aleve PM 25 MG / 220 MG Oral TabletPSN82891458-ab0d-459a-8602-dcebd22c301016
1550957diphenhydrAMINE HCl 25 MG / naproxen sodium 220 MG Oral TabletPSN82891458-ab0d-459a-8602-dcebd22c301016
1550963diphenhydramine hydrochloride 25 MG / naproxen sodium 220 MG Oral Tablet [Aleve PM]SBD82891458-ab0d-459a-8602-dcebd22c301016
1550957diphenhydramine hydrochloride 25 MG / naproxen sodium 220 MG Oral TabletSCD82891458-ab0d-459a-8602-dcebd22c301016
1550963Aleve PM (diphenhydramine hydrochloride 25 MG / naproxen sodium 220 MG) Oral TabletSY82891458-ab0d-459a-8602-dcebd22c301016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0280-1200-01002801200011 BOTTLE in 1 CARTON (0280-1200-01) / 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2014-09-090000-00-00NoNoCurrent
0280-1200-02002801200022 TABLET, FILM COATED in 1 POUCH (0280-1200-02) 2014-09-090000-00-00NoNoCurrent
0280-1200-0300280120003160 TABLET, FILM COATED in 1 BOTTLE (0280-1200-03) 2014-09-090000-00-00NoNoCurrent
0280-1200-04002801200041 BOTTLE in 1 CARTON (0280-1200-04) / 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2014-09-090000-00-00NoNoCurrent
0280-1200-050028012000580 TABLET, FILM COATED in 1 BOTTLE (0280-1200-05) 2014-09-090000-00-00NoNoCurrent
0280-1200-08002801200081 BOTTLE in 1 CARTON (0280-1200-08) / 250 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-07-010000-00-00NoNoCurrent
0280-1200-20002801200201 BOTTLE in 1 CARTON (0280-1200-20) / 20 TABLET, FILM COATED in 1 BOTTLE1 bottle2014-09-090000-00-00NoNoCurrent
0280-1200-40002801200401 BOTTLE in 1 CARTON (0280-1200-40) / 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2014-09-090000-00-00NoNoCurrent
0280-1200-80002801200801 BOTTLE in 1 CARTON (0280-1200-80) / 80 TABLET, FILM COATED in 1 BOTTLE1 bottle2014-09-090000-00-00NoNoCurrent