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 18 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin Enteric CoatedASPIRIN 81 MGGrocery Outlet79c64e27-87aa-4081-8cbf-343768b00b902026-03-19WarningsExact identifier
application number: M013
ASPIRIN LOW DOSEASPIRINMAJOR PHARMACEUTICALS7c24aff7-2b96-27ac-e053-2991aa0a57142026-03-19WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENBryant Ranch Prepackea417ddb-54b3-49e2-bec1-8fe450d9990c2026-03-19WarningsExact identifier
application number: M013
CHILDRENS PAIN AND FEVERACETAMINOPHENHyVee Inc3b08738e-cde2-4843-b609-8f12582c6d082026-03-18WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINESalado Sales, Inc.0666f082-84f3-4041-a322-311188a156702026-03-18WarningsExact identifier
application number: M013
AMAZON BASICS ACETAMINOPHENACETAMINOPHENAmazon.com Services LLC3c2914a4-913e-7e50-e063-6294a90aff3a2026-03-18WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENBryant Ranch Prepackc6cec390-004e-45f6-9388-c662a979f37d2026-03-17WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINChain Drug Marketing Association, Inc.b32ada58-a098-47d2-9ed2-4d59186577092026-03-16WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLH E B21a4cc76-a7cb-4d11-bd1b-7d5c6a332f2a2026-03-16WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLTopco Associates, LLCeaa98783-5800-4ae9-832f-f4a1fd1790fd2026-03-16WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINWalgreen Company413b3b95-2867-4534-8290-54f477cccf1e2026-03-16WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENGrocery Outlet, Inc.4454d02a-ba49-6c8c-e063-6294a90a47092026-03-12WarningsExact identifier
application number: M013
Aspirin Enteric CoatedASPIRINCVS Pharmacyc55304be-bfc0-46a8-a37e-2e6ba90983942026-03-12WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENAmerisource Bergenc280ac64-920c-4d03-9190-03e0196ed5ef2026-03-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd79828d8-9279-4ae9-8872-aeca641be5d92026-03-10WarningsExact identifier
application number: M013
Adult Low Dose Enteric Coated AspirinASPIRINPreferred Pharmaceuticals Inc.1b5b8bb1-c45d-48f0-b275-9ce1f769fed42026-03-09WarningsExact identifier
application number: M013
foster and thrive childrens pain and feverACETAMINOPHENStrategic Sourcing Services LLCe495a27e-eb64-4c42-8942-43bab99181722026-03-07WarningsExact identifier
application number: M013
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLCVS PHARMACY67a190c3-7de0-4f57-be94-d6b8285e12202026-03-06WarningsExact identifier
application number: M013
Back and Body Pain ReliefASPIRIN, CAFFEINEWinCo Foods, LLCcf5c15e9-c45d-4bd6-a887-fd74de5f81b92026-03-06WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENTopco Associates, LLC87af092c-99e6-475d-81af-b9fd8fc337d72026-03-06WarningsExact 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