Pain Relief PM

Product NDC
55910-655
11-digit product format
559100655
Labeler code
55910
Product ID
55910-655_576227a6-39d3-4f42-b52f-261ad038c632
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Diphenhydramine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
DOLGENCORP, LLC
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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Pain Relief PM
Brand name suffix
Extra Strength
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1092189Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8e65478b-7a7b-416c-b8e3-23dad79f8cc1Available on FDA.report

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
55910-655-10Pain Relief PMExtra Strength1 in 1 CARTONTABLET, COATED116
55910-655-10Pain Relief PMExtra Strength40 in 1 BOTTLE, PLASTICTABLET, COATED4016
55910-655-31Pain Relief PMExtra Strength80 in 1 BOTTLE, PLASTICTABLET, COATED8016
55910-655-31Pain Relief PMExtra Strength1 in 1 CARTONTABLET, COATED116

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]3
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]3
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]3
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-655PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, COATED [DOLGENCORP, LLC]15Current NDC, Legacy NDC, 4 package rows20250416_8e65478b-7a7b-416c-b8e3-23dad79f8cc1.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 19 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin Regular StrengthASPIRINRite Aid Corporation879e2258-f61b-47ad-a4b1-7d1e788235702026-03-05WarningsExact identifier
application number: M013
AspirinASPIRINARMY AND AIR FORCE EXCHANGE SERVICE87c580d3-6009-4be9-aea7-13539fbe6e312026-03-05WarningsExact identifier
application number: M013
Aspirin Low Dose Chewable OrangeASPIRINMAJOR PHARMACEUTICALSfb3a8e38-e991-49c9-93dc-1d29c0a97ba32026-03-05WarningsExact identifier
application number: M013
Infants Pain and FeverACETAMINOPHENKroger41e149df-4140-95cc-e063-6294a90a866b2026-03-03WarningsExact identifier
application number: M013
Medique Pain OffACETAMINOPHEN, ASPIRIN, CAFFEINESportpharm LLC2b35acdc-ff88-46e6-a108-5240aac1d53f2026-03-03WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENBest Choice (Valu Merchandisers Company)a8a0d9a5-1a36-4ed2-ae9c-7e1a3d674c072026-03-03WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENHyVee Inc6820a515-4004-407b-969b-c4069dc0c3b52026-02-26WarningsExact identifier
application number: M013
Acetaminophen, Diphenhydramine HydrochlorideACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDELEADER/ Cardinal Health 110, Inc.7be4d67e-1af9-f059-e053-2991aa0a382e2026-02-26WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENNCS HealthCare of KY, LLC dba Vangard Labsf32fc2e9-c0e3-4a25-8399-9cdba6ae8a162026-02-26WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENNCS HealthCare of KY, LLC dba Vangard Labs1f4ac0e6-e986-4c22-8248-0691d64e1a302026-02-26WarningsExact identifier
application number: M013
Childrens Chewable AcetaminophenACETAMINOPHENDiscount Drug Martf413a617-1166-4940-b6ec-fae32238a7802026-02-26WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENNCS HealthCare of KY, LLC dba Vangard Labs19735691-33f3-4e19-85ad-e5f270251ec52026-02-26WarningsExact identifier
application number: M013
Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl LiquidACETAMINOPHEN, DIPHENHYDRAMINE HCLKroger44520aa1-b63f-4239-e063-6394a90a5e142026-02-25WarningsExact identifier
application number: M013
Leader Extra Strength Effervescent Antacid and Pain RelieverASPIRIN, CITRIC ACID, SODIUM BICARBONATECardinal Healthc5d7bf5f-3e59-52f2-e053-2a95a90a4a002026-02-25WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED12fd643d-7c60-453f-a81f-407ed20e87252026-02-25WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd96a1531-772b-4a5c-89e4-66fff1fa3d782026-02-25WarningsExact identifier
application number: M013
Gentle Care KitZINC OXIDEKenvue Brands LLC4b8f7a5a-2fc4-ea00-e063-6294a90ab95b2026-02-24WarningsExact identifier
application number: M013
Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATEHaleon US Holdings LLC444fa225-c204-45d1-b3b3-aa5650ee5d072026-02-23WarningsExact identifier
application number: M013
Excedrin Extra Strength and Excedrin Tension HeadacheACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINEHaleon US Holdings LLC2c8df1c7-7864-48df-939c-d9ae22e0f52c2026-02-23WarningsExact identifier
application number: M013
Equate Childrens Pain and FeverACETAMINOPHENWal-Mart Stores Inc40eedfe9-54e1-40a2-b4a2-55ff708b89cd2026-02-23WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN8e65478b-7a7b-416c-b8e3-23dad79f8cc116
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD8e65478b-7a7b-416c-b8e3-23dad79f8cc116
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY8e65478b-7a7b-416c-b8e3-23dad79f8cc116

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55910-655-10559100655101 BOTTLE, PLASTIC in 1 CARTON (55910-655-10) / 40 TABLET, COATED in 1 BOTTLE, PLASTIC2007-12-170000-00-00NoNoCurrent
55910-655-31559100655311 BOTTLE, PLASTIC in 1 CARTON (55910-655-31) / 80 TABLET, COATED in 1 BOTTLE, PLASTIC2007-12-170000-00-00NoNoCurrent