FDA.reportPublic FDA data

Pain Reliever PM

Product NDC
36800-466
11-digit product format
368000466
Labeler code
36800
Product ID
36800-466_8f866a48-29e1-489c-9798-e5b9c1615243
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
TOP CARE (Topco Associates LLC)
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-11-05
Marketing end
2027-12-28
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
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
Brand name suffix
Extra Strength

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
923b443d-73cc-4c52-92e4-a075786b1ae3Available 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
36800-466-10Pain Reliever PMExtra Strength100 in 1 BOTTLE, PLASTICTABLET, COATED1008
36800-466-10Pain Reliever PMExtra Strength1 in 1 BOXTABLET, COATED18
36800-466-50Pain Reliever PMExtra Strength1 in 1 BOXTABLET, COATED18
36800-466-50Pain Reliever PMExtra Strength50 in 1 BOTTLE, PLASTICTABLET, COATED508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-466PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]8Current NDC, Legacy NDC, 4 package rows20250228_923b443d-73cc-4c52-92e4-a075786b1ae3.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 41 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good sense pain reliefACETAMINOPHENNuCare Pharmaceuticals,Inc.3c1f505d-0319-a179-e063-6294a90a0b172025-08-11WarningsExact identifier
application number: M013
AspirinASPIRINPROSTAT FIRST AID3bdb9d89-9000-69f9-e063-6294a90a0c972025-08-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENProstat First Aid3bdbea6a-3f11-9142-e063-6294a90a20ea2025-08-08WarningsExact identifier
application number: M013
Aspi-CorASPIRINL.N.K. International, Inc.9f919a48-ffd8-49fa-b6fd-ec71cc12e64b2025-08-08WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINA-S Medication Solutions8575ef9d-2eae-412a-a252-82b03f4d52752025-08-08WarningsExact identifier
application number: M013
AspirinASPIRINA-S Medication Solutions7a91b1df-8d6d-4205-9822-bc4d800555f72025-08-08WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENBryant Ranch Prepack3d6bf733-800c-420a-a9ab-ae4a261347992025-08-08WarningsExact identifier
application number: M013
AspirinASPIRINA-S Medication Solutions44b8c203-37c5-425e-9110-f7eb614f9c2d2025-08-08WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINCHAIN DRUG MARKETING ASSOCIATION INCc46688ec-e976-4f76-9265-645f59970ff52025-08-06WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEP & L Development, LLCc54ad829-f2e8-4367-b439-af20b0ef8ad22025-08-06WarningsExact identifier
application number: M013
TYLENOL Regular StrengthACETAMINOPHENKenvue Brands LLC398d8996-b522-a3cd-e063-6394a90ac2c82025-08-06WarningsExact identifier
application number: M013
AspirinASPIRINMarlex Pharmaceuticals Inc.cc7013ea-cf30-6f59-e053-2a95a90a11482025-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENProstat First Aid3ba313db-bafe-1947-e063-6294a90a528c2025-08-05WarningsExact identifier
application number: M013
MEDIQUE APAP acetaminophenMEDIQUE APAP ACETAMINOPHENHF Acquisition Co LLC, DBA HealthFirst3ba5c802-fe5a-e42a-e063-6394a90ae67e2025-08-05WarningsExact identifier
application number: M013
meijer EXTRA STRENGTH Pain Relief PM CAPLETACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEMeijer, Inc.376fed3b-7625-6379-e063-6394a90a188d2025-08-05WarningsExact identifier
application number: M013
CAREONE INFANTS ACETAMINOPHENACETAMINOPHENRetail Business Services, LLCb8024ec2-97c6-4aa1-b1dd-894164f488112025-08-04WarningsExact identifier
application number: M013
Exaprin PlusASPIRIN, ACETAMINOPHEN, CAFFEINEHART Health8a9ca680-e6cf-4ee4-8a5f-bd6d7470b8482025-08-04WarningsExact identifier
application number: M013
AspirinASPIRINProficient Rx LP2ef0757a-fe5f-47de-906a-a4d47a0d05342025-08-01WarningsExact identifier
application number: M013
Good Sense Pain ReliefACETAMINOPHENProficient Rx LPb4cb4a62-9ef7-4185-8770-e9a806c2fb3f2025-08-01WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENAAA Pharmaceutical, Inc.36ad21a3-6229-e91b-e063-6394a90a79332025-07-29WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN923b443d-73cc-4c52-92e4-a075786b1ae38
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD923b443d-73cc-4c52-92e4-a075786b1ae38
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY923b443d-73cc-4c52-92e4-a075786b1ae38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-466-10368000466101 BOTTLE, PLASTIC in 1 BOX (36800-466-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2021-11-052027-12-28NoNoCurrent
36800-466-50368000466501 BOTTLE, PLASTIC in 1 BOX (36800-466-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2021-11-052027-12-28NoNoCurrent