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 46 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RIGHT REMEDIES LOW DOSE Aspirin 81mgASPIRINStrive Pharmaceuticals Inc.322c0e50-cf75-51ab-e063-6294a90a92352025-04-14WarningsExact identifier
application number: M013
Bayer Aspirin Regimen Chewable Low Dose Aspirin OrangeASPIRINBayer HealthCare LLC.0c6ae05f-760f-34d1-e054-00144ff88e882025-04-11WarningsExact identifier
application number: M013
Arthriten Inflammatory Pain FormulaACETAMINOPHEN, ASPIRIN, CAFFEINEKobayashi Healthcare International, Incc280ca89-4fb5-4050-90ee-d706a550a1ef2025-04-11WarningsExact identifier
application number: M013
Bayer Back and Body Extra StrengthASPIRIN,CAFFEINEBayer HealthCare LLC.0c77c484-6caf-12ca-e054-00144ff88e882025-04-10WarningsExact identifier
application number: M013
Adult Low Dose Enteric Coated AspirinASPIRINNuCare Pharmaceuticals, Inc.324937c3-c558-bc79-e063-6294a90acc8e2025-04-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHEN 500MGCVS Pharmacy, Inc.1fde6487-6682-99a3-e063-6294a90a36702025-04-04WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENBryant Ranch Prepackbdc466c9-d9ae-4293-b7ea-46fb517661c62025-04-01WarningsExact identifier
application number: M013
Adult Low Dose Enteric Coated AspirinASPIRINGeri-Care Pharmaceutical Corpe327a52a-0e31-44b7-9823-7f60d070ae522025-04-01WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENProficient Rx LP9af5ccc8-aac0-4339-a9f6-58fdc9b91c572025-04-01WarningsExact identifier
application number: M013
ASPIRIN 325 MG ECASPIRINBryant Ranch Prepack9d0449d2-c0c6-4e74-931b-35dc625840282025-03-31WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINBryant Ranch Prepackcce1e8bd-63c8-403a-bc32-e6788493f6042025-03-31WarningsExact identifier
application number: M013
Adwe Feverx Acetaminophen Caplets, 500 mg Extra StrengthACETAMINOPHENAurex Laboratories Limited Liability Company948c5826-6f35-484d-bb3f-cecf6a4b5c132025-03-31WarningsExact identifier
application number: M013
Infants Pain and FeverACETAMINOPHENWALGREENS281a530b-c759-50eb-e063-6394a90abb4f2025-03-28WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLWR Group, Inc.8281771c-485c-42a9-9a1c-9a7a4298c5b82025-03-28WarningsExact identifier
application number: M013
Acetaminophen Regular strengthACETAMINOPHENPD-Rx Pharmaceuticals, Inc.4181efc2-d183-410c-b647-233444c57e322025-03-20WarningsExact identifier
application number: M013
CounterAct PainACETAMINOPHENMelaleuca, Inc.7faf76b4-7f25-377d-e053-2a91aa0a19d42025-03-20Boxed warning, WarningsExact identifier
application number: M013
MejoralACETAMINOPHEN, CAFFEINEOPMX LLC0bccf571-fcb9-2dd5-e063-6294a90a5f162025-03-19WarningsExact identifier
application number: M013
ARTRIFIN 24 CAPLETSACETAMINOPHEN, ASPIRIN, CAFFEINEOPMX LLCe7f15c2b-a730-b54f-e053-2a95a90a3b3e2025-03-19WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLTARGET Corporation1fc3806e-a5c4-4a6e-951b-dfbf9f5771f12025-03-17WarningsExact identifier
application number: M013
Signature Select Effervescent Pain ReliefASPIRINSafeway Inc.304fca65-2867-c963-e063-6394a90a183f2025-03-14WarningsExact 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