FDA.reportPublic FDA data

Pain Reliever PM

Product NDC
55319-562
11-digit product format
553190562
Labeler code
55319
Product ID
55319-562_1dc1bd15-bee3-4602-9687-5b2e1d55c00a
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-01
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 Reliever PM
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
7a98d4d9-54e2-45c1-a76a-7f1907566e95Available 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
55319-562-10Pain Reliever PM100 in 1 BOTTLE, PLASTICTABLET, COATED1007
55319-562-10Pain Reliever PM1 in 1 BOXTABLET, COATED17
55319-562-24Pain Reliever PM24 in 1 BOTTLE, PLASTICTABLET, COATED247
55319-562-24Pain Reliever PM1 in 1 BOXTABLET, COATED17
55319-562-50Pain Reliever PM1 in 1 BOXTABLET, COATED17
55319-562-50Pain Reliever PM50 in 1 BOTTLE, PLASTICTABLET, COATED507

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-562PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [FAMILY DOLLAR (FAMILY WELLNESS)]6Current NDC, 6 package rows20250410_7a98d4d9-54e2-45c1-a76a-7f1907566e95.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 44 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin Low DoseASPIRINATLANTIC BIOLOGICALS CORP.024c5054-959f-4ea5-a71f-c0e16cc4b90c2025-06-24WarningsExact identifier
application number: M013
CHILDRENS ACETAMINOPHENCHILDRENS ACETAMINOPHEN ORALAARNA USA INC.38070d15-2678-4e59-e063-6294a90ab6902025-06-20WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENMorning Star OTC8502ea21-937d-4b33-a3e0-ffab5dc38cd82025-06-19WarningsExact identifier
application number: M013
Tylenol PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEMorning Star OTC6cd07a01-7034-4994-bbd3-bedcdf7d5b832025-06-19WarningsExact identifier
application number: M013
DRX CHOICE Tension HeadacheACETAMINOPHEN, CAFFEINERaritan Pharmaceuticals Inc.8a5cb38b-669d-4177-b33b-d73c7ef48d182025-06-13WarningsExact identifier
application number: M013
good sense childrens pain and feverACETAMINOPHENNuCare Pharmaceuticals,Inc.3777f4fb-d279-199d-e063-6394a90acf362025-06-13WarningsExact identifier
application number: M013
Aspirina CafeinaASPIRIN,CAFFEINEBayer HealthCare LLC.2e709acc-325a-baca-e063-6394a90a24be2025-06-12WarningsExact identifier
application number: M013
AspirinASPIRINCHAIN DRUG MARKETING ASSOCIATION, INC.696f55b1-536c-40c4-91f7-b572c39220db2025-06-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS Pharmacy, Inc.6dea9e11-ff99-63c7-e053-2a91aa0a5b542025-06-10WarningsExact identifier
application number: M013
Children Acetaminophen Oral SolutionACETAMINOPHENMAJOR PHARMACEUTICALScfca5147-f390-40bd-8f13-c5b3b8d1c5b02025-06-09WarningsExact identifier
application number: M013
AspirinASPIRINTrifecta Pharmaceuticals USA LLC372be427-acbd-c10c-e063-6294a90a572d2025-06-09WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS Pharmacyd6c8118c-bf78-4194-9b14-8de33c3ecdb72025-06-06WarningsExact identifier
application number: M013
Dolo-NeuroBionACETAMINOPHENBENARD INDUSTRIES INCb8310770-84d1-4a6f-8e23-9974947f92f12025-06-04WarningsExact identifier
application number: M013
Menstrual Complete Maximum StrengthACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATERite Aid Corporation69bda7d7-8660-4e8d-b8ac-892a3b1f21242025-06-03WarningsExact identifier
application number: M013
Kids Pain and FeverACETAMINOPHENKinderFarms, LLCfb74e8f9-d72f-4681-90bd-df48364405b52025-06-01WarningsExact identifier
application number: M013
Pain and Fever ChildrensACETAMINOPHENP & L Development, LLCb815fcae-8bba-4737-ac10-29a32fb692752025-05-30WarningsExact identifier
application number: M013
Infants Pain and FeverACETAMINOPHENKinderFarms, LLC81cc4900-226b-4c49-ba9c-5747d2a501b12025-05-29WarningsExact identifier
application number: M013
good sense pain relief pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLBryant Ranch Prepacke08a7ab1-4b68-422a-97bd-2c53266339432025-05-29WarningsExact identifier
application number: M013
Acetaminophen GelcapsACETAMINOPHENKroger30d3f2d0-da35-7f6f-e063-6294a90a9c222025-05-23WarningsExact identifier
application number: M013
Kids Pain and FeverACETAMINOPHENGenexa Inc.fcffa7e6-145c-6bc0-e053-6294a90a47512025-05-23WarningsExact identifier
application number: M013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
55319-562-10553190562101 BOTTLE, PLASTIC in 1 BOX (55319-562-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2023-07-01NoNoCurrent
55319-562-24553190562241 BOTTLE, PLASTIC in 1 BOX (55319-562-24) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC2023-07-01NoNoCurrent
55319-562-50553190562501 BOTTLE, PLASTIC in 1 BOX (55319-562-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2023-07-01NoNoCurrent