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 64 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Neighbor Pharmacy AspirinASPIRINAmerisource Bergend9db6659-6afc-431b-ae05-c941775e63662024-09-01WarningsExact identifier
application number: M013
Topcare AspirinASPIRINTopco Associates LLC8133c3fc-97ce-46b4-8580-7da9f09f622b2024-08-30WarningsExact identifier
application number: M013
Tylenol PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Inc639f4e01-9723-a619-e053-2991aa0a549a2024-08-27WarningsExact identifier
application number: M013
Extra Strength Acetaminohpen Adult Rapid Burst CherryACETAMINOPHENMajor Pharmaceuticals9e7543d9-6249-45b5-b67d-c1b439423b9c2024-08-27WarningsExact identifier
application number: M013
aspirinASPIRINMajor Pharmaceuticals58684138-04d1-44a4-bc52-c5b85d93d7a62024-08-23WarningsExact identifier
application number: M013
Up and Up childrens acetaminophenACETAMINOPHENTarget Corporation9c3ba4dd-f51b-46ce-91b8-8b617c7b78da2024-08-23WarningsExact identifier
application number: M013
CVS Effervescent Pain RelieverASPIRINCVS PHARMACY0761147f-1337-606e-e063-6394a90abd5d2024-08-22WarningsExact identifier
application number: M013
pain relieverACETAMINOPHENWalgreen Company8255900a-2d58-4261-8df7-f283198835702024-08-21WarningsExact identifier
application number: M013
Pain and FeverACETAMINOPHENH E B86a072a9-c3b8-47f7-8598-d66e3d30e7622024-08-21WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENKroger Companyd965eba0-b268-41b2-8e02-5f6d769a44d72024-08-18WarningsExact identifier
application number: M013
equate pain and fever childrensACETAMINOPHENWal-Mart Stores Incea68d735-c677-4280-a3a3-ae3eb5ff74622024-08-17WarningsExact identifier
application number: M013
childrens pain and feverACETAMINOPHENCVS Pharmacyfac408f0-ebb6-4c72-88ee-2ba85867859c2024-08-16WarningsExact identifier
application number: M013
Regular Strength Pain ReliefACETAMINOPHENBryant Ranch Prepack3f0c32b1-2c54-4ca3-9759-9e5dd9d7ad242024-08-14WarningsExact identifier
application number: M013
Quality Choice Effervescent Antacid and Pain Relief - Extra StrengthASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEChain Drug Marketing Association1f926637-a61c-8eb7-e063-6394a90a65022024-08-13WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharma6ec12573-03d6-40c1-9945-d345b401e0622024-08-12WarningsExact identifier
application number: M013
CareOne Infants AcetaminophenACETAMINOPHENAmerican Sales Companyeacee273-abd7-4ea4-bcaa-7f74abcc9feb2024-08-07WarningsExact identifier
application number: M013
infants pain and feverACETAMINOPHENKroger Company7dbe284a-c0d5-4ac4-8445-611610f3c0fb2024-08-02WarningsExact identifier
application number: M013
Dollar General Effervescent Pain RelieverASPIRINDolgencorp, Inc1deab362-a325-3a00-e063-6294a90a9acd2024-08-01WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENFSA STORE INC.1cd6a3e6-1376-0b7b-e063-6394a90af3d12024-07-30WarningsExact identifier
application number: M013
pain relief pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLPublix Super Markets Inc42d271b7-b45f-4497-8de2-4e05b4bebfa92024-07-17WarningsExact 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