FDA.reportPublic FDA data

Pain Relief PM

Product NDC
72090-006
11-digit product format
720900006
Labeler code
72090
Product ID
72090-006_99b7581b-b3ad-4191-8245-665177a21686
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DIPHENHYDRAMINE
Dosage form
TABLET
Route
ORAL
Labeler
Pioneer Life Sciences, LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-08
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN
Active strength
25; 500 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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct72090-006IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage72090-00672090-006-25IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup
362O9ITL9DInternal 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
ad29a37f-39a2-5c84-e053-2995a90a2f39Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72090-006-252024-05-08C16284748780-1f386c649-a227-0266-e053-dadaa90a7c1aPain Relief PM
72090-006-252023-01-30C16284748780-1f386c649-a227-0266-e053-dadaa90a7c1aPain Relief PM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72090-006-25Pain Relief PM375 in 1 BOTTLETABLET3754

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72090-006PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE) TABLET [PIONEER LIFE SCIENCES, LLC]3Current NDC, Legacy NDC, 1 package rows20240509_ad29a37f-39a2-5c84-e053-2995a90a2f39.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 29 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Regular Strength Pain ReliefACETAMINOPHENVALU MERCHANDISERS COMPANYf7e87eac-59fb-4a72-b5c6-02953112be6a2025-12-11WarningsExact identifier
application number: M013
AspirinASPIRINVALU MERCHANDISERS COMPANY049ec1aa-66b3-9273-e063-6294a90a221b2025-12-11WarningsExact identifier
application number: M013
Aspirin 325ASPIRINWalgreen Companyf7a5d612-443c-4701-ad3b-8eb53c87bece2025-12-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharma355a094c-bed9-4959-8cf0-619f0e2461052025-12-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharmafac4e0c6-684f-45a1-99f2-de4de4017cc82025-12-11WarningsExact identifier
application number: M013
Pain Reliever PM extra strengthACETAMINOPHEN DIPHENHYDRAMINE HCLP & L Development, LLC90eba2e8-52c3-43f5-ba93-4a520368c7f42025-12-11WarningsExact identifier
application number: M013
Midol Complete, Travel BASIXACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATELil' Drug Store Products, Incd6d47af8-5f8c-4c8c-a8c6-aa214ec23bca2025-12-10WarningsExact identifier
application number: M013
Tylenol PM Extra Strength, CVP HEALTHACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDELil' Drug Store Products, Inc.643371f2-e330-441e-8932-b3aec4b179d22025-12-10WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINUnited Natural Foods, Inc. dba UNFI18b79449-5c4c-41ce-9609-80f5efa0375c2025-12-09WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENAAA Pharmaceutical, Inc.36ad34f4-4e66-f371-e063-6394a90ae76a2025-12-09WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENLIDL US LLCec543339-20ab-2cba-e053-2995a90ac7402025-12-09WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION, INC.c57c10fc-f182-4153-8974-ef359a5f5ac12025-12-09WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHEBf7958347-4e9c-4698-8749-7ca7023ee2ba2025-12-09WarningsExact identifier
application number: M013
Pain Relief Rapid Release Gelcaps Extra StrengthACETAMINOPHENSafewayc830d1ac-c4c5-4eb1-98bb-22707cb6db912025-12-09WarningsExact identifier
application number: M013
Menstrual Pain Relief CompleteACETAMINOPHEN, PYRILAMINE MALEATE, CAFFEINEShield Pharmaceuticals Corp5efd6c61-74ed-4253-896a-e4a40bd8f25b2025-12-09WarningsExact identifier
application number: M013
Excedrin Extra Strength, TRAVEL BASIXACETAMINOPHEN, ASPIRIN, AND CAFFEINELil Drug Store Products, Inc7f0f8b3c-c226-4a3a-af46-a708f345e4f52025-12-09WarningsExact identifier
application number: M013
childrens acetaminophenACETAMINOPHENUnited Natural Foods, Inc. dba UNFIf65203a2-64f0-4138-97e4-6eab991941782025-12-09WarningsExact identifier
application number: M013
Pain Reliever PM, Extra Strength, 24-7 Life by 7-ElevenACETAMINOPHEN, DIPHENHYDRAMINE HCL TABLET, FILM COATEDLil' Drug Store Products, Inc.45735cd8-ac07-3f12-e063-6294a90a0cb22025-12-08WarningsExact identifier
application number: M013
BERKLEY AND JENSEN RAPID RELEASE ACETAMINOPHENACETAMINOPHENBJWCe27b6637-ef32-44b5-a531-b6617d02fbbf2025-12-08WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREENS3f9f1740-9e8b-6a2d-e063-6294a90a67cb2025-12-06WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSNad29a37f-39a2-5c84-e053-2995a90a2f394
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCDad29a37f-39a2-5c84-e053-2995a90a2f394
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSYad29a37f-39a2-5c84-e053-2995a90a2f394

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72090-006-2572090000625375 TABLET in 1 BOTTLE (72090-006-25) 375 tablet2024-05-080000-00-00NoNoCurrent