FDA.reportPublic FDA data

Pain Reliever PM

Product NDC
0363-0556
11-digit product format
003630556
Labeler code
0363
Product ID
0363-0556_ba35f08c-d6de-43c5-8c52-201c6a39247d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Walgreen Company
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-12-17
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
500; 25 mg/1; mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pain Reliever PM
Brand name suffix
Extra Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, TC2D6JAD40
Rxcui1092189

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0556-01Pain Reliever PMExtra Strength1 in 1 CARTONTABLET, COATED120
0363-0556-01Pain Reliever PMExtra Strength30 in 1 BOTTLE, PLASTICTABLET, COATED3020
0363-0556-09Pain Reliever PMExtra Strength1 in 1 CARTONTABLET, COATED120
0363-0556-09Pain Reliever PMExtra Strength20 in 1 BOTTLE, PLASTICTABLET, COATED2020
0363-0556-31Pain Reliever PMExtra Strength1 in 1 CARTONTABLET, COATED120
0363-0556-31Pain Reliever PMExtra Strength80 in 1 BOTTLE, PLASTICTABLET, COATED8020
0363-0556-54Pain Reliever PMExtra Strength375 in 1 BOTTLE, PLASTICTABLET, COATED37520
0363-0556-57Pain Reliever PMExtra Strength125 in 1 BOTTLE, PLASTICTABLET, COATED12520

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0556-01EA - Each0363-0556b8137f68-38f0-4743-bb43-4468480d5e9d12025-01-14
0363-0556-09EA - Each0363-05561488c3ec-daa4-4620-b9cf-e8a6bea6b59d12013-08-02
0363-0556-54EA - Each0363-0556188ee79f-d073-4965-9b01-2220cf224bdc12015-11-12
0363-0556-57EA - Each0363-05566ca2d00c-a047-4e75-b8a4-090b1510d1e712015-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0556PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [WALGREEN COMPANY]19Current NDC, Legacy NDC, 8 package rows20250101_b4d8860b-d72f-4789-945e-1c6420a8efab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSNb4d8860b-d72f-4789-945e-1c6420a8efab20
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCDb4d8860b-d72f-4789-945e-1c6420a8efab20
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSYb4d8860b-d72f-4789-945e-1c6420a8efab20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0556-01003630556011 BOTTLE, PLASTIC in 1 CARTON (0363-0556-01) / 30 TABLET, COATED in 1 BOTTLE, PLASTIC2007-12-17NoNoCurrent
0363-0556-09003630556091 BOTTLE, PLASTIC in 1 CARTON (0363-0556-09) / 20 TABLET, COATED in 1 BOTTLE, PLASTIC2007-12-170000-00-00NoNoCurrent
0363-0556-31003630556311 BOTTLE, PLASTIC in 1 CARTON (0363-0556-31) > 80 TABLET in 1 BOTTLE, PLASTIC2007-12-172022-02-27NoNoCurrent
0363-0556-5400363055654375 TABLET in 1 BOTTLE, PLASTIC (0363-0556-54) 375 tablet2007-12-170000-00-00NoNoCurrent
0363-0556-5700363055657125 TABLET in 1 BOTTLE, PLASTIC (0363-0556-57) 125 tablet2007-12-170000-00-00NoNoCurrent