Pain Relief PM

Product NDC
37808-795
11-digit product format
378080795
Labeler code
37808
Product ID
37808-795_458b73eb-31e7-5cf1-e063-6294a90a5c79
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Diphenhydramine Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
HEB
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-02-01
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
2026-12-31
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
2026-12-31

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
f7958347-4e9c-4698-8749-7ca7023ee2baAvailable 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
37808-795-03Pain Relief PMExtra Strength100 in 1 BOTTLE, PLASTICTABLET, COATED1006
37808-795-03Pain Relief PMExtra Strength1 in 1 CARTONTABLET, COATED16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-795PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [HEB]5Current NDC, Legacy NDC, 2 package rows20241023_f7958347-4e9c-4698-8749-7ca7023ee2ba.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 17 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AspirinASPIRINCardinal Health 110, LLC. DBA Leader318cc982-23a9-4804-b6fb-248f772d7a382026-04-02WarningsExact identifier
application number: M013
Chewable Acetaminophen ChildrensACETAMINOPHENCardinal Health 110, LLC. DBA Leader8a18565c-b84e-43f8-8e96-e1dbcc39f08b2026-04-02WarningsExact identifier
application number: M013
Childrens Pain RelieverACETAMINOPHENH E Bc713556c-cb9e-4ed2-bc2f-49b3d6256c0f2026-04-02WarningsExact identifier
application number: M013
AspirinASPIRINDiscount Drug Mart4a1e9c79-5036-4c69-82f9-e48abc972b472026-04-02WarningsExact identifier
application number: M013
WispirinASPIRINWisdrug AG4e70ec5e-d033-a525-e063-6394a90a5a932026-04-01WarningsExact identifier
application number: M013
Aspirin RegimenASPIRINCardinal Health 110, LLC. DBA Leaderef2d75ee-9ed7-4b53-adbc-2ec40364da632026-03-31WarningsExact identifier
application number: M013
Tension Headache ReliefACETAMINOPHEN, CAFFEINEHi-Tech Nutraceuticals, LLCb119ba37-0ee3-851a-e053-2995a90a85b12026-03-31WarningsExact identifier
application number: M013
AspirinASPIRINRMT HEALTH LLC4dc7229d-c895-1f80-e063-6394a90abfc32026-03-30WarningsExact identifier
application number: M013
AspirinASPIRINPD-Rx Pharmaceuticals, Inc.d1f05e56-c830-4f85-b685-2a5965d10a1c2026-03-26WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENBryant Ranch Prepackad01aea6-4af3-469b-b99d-e1e66aa40e8d2026-03-25WarningsExact identifier
application number: M013
aspirinASPIRINMeijer Distribution Incc550b92e-de54-4599-9534-bd3022b0a86d2026-03-25WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINAmerisourceBergen (Good Neighbor Pharmacy) 46122db187226-0770-4934-90a4-c6ca50bdecef2026-03-25WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)804d4b63-1bbe-47c0-ad49-39ddbeade6a32026-03-25WarningsExact identifier
application number: M013
childrens pain and feverACETAMINOPHENHyVee Inc9d9c2bf6-8660-4987-8794-936d3102da8d2026-03-24WarningsExact identifier
application number: M013
Childrens Pain RelieverACETAMINOPHENBJWC (Berkley & Jensen / BJ's)851228ea-eaf3-452b-a9ce-8cd244a0eaf32026-03-24WarningsExact identifier
application number: M013
FirstCare Childrens Pain Fever AcetaminophenACETAMINOPHEN 80 MGUSpharma Ltd9fc05ba6-5667-457e-82c1-a8b4e16cadda2026-03-23WarningsExact identifier
application number: M013
AspirinASPIRINAarkish Pharmaceuticals NJ Inc.e5e9e1ce-666a-461f-8287-a4642902067c2026-03-23WarningsExact identifier
application number: M013
Chewable Aspirin Low DoseCHEWABLE ASPIRINGrocery Outlet609c0389-8bed-4483-84fa-73ee73fdb4e42026-03-20WarningsExact identifier
application number: M013
Adult Low Dose Pain RelieverASPIRINTWIN MED LLCa395acf4-f487-4c98-8c44-ca2aaaf72deb2026-03-20WarningsExact identifier
application number: M013
RapidolACETAMINOPHENPharmadel LLC3a210860-1fc1-e496-e063-6394a90a87052026-03-20WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSNf7958347-4e9c-4698-8749-7ca7023ee2ba6
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCDf7958347-4e9c-4698-8749-7ca7023ee2ba6
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSYf7958347-4e9c-4698-8749-7ca7023ee2ba6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
37808-795-03378080795031 BOTTLE, PLASTIC in 1 CARTON (37808-795-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2013-02-010000-00-00NoNoCurrent