FDA.reportPublic FDA data

Pain Relief PM

Product NDC
68998-195
11-digit product format
689980195
Labeler code
68998
Product ID
68998-195_252639e3-38cf-04f0-e063-6294a90a94ad
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Diphenhydramine Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
MARC GLASSMAN, INC.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-10-05
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
e221bbce-83de-0f03-e053-2995a90abca5Available 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
68998-195-02Pain Relief PMExtra Strength50 in 1 BOTTLE, PLASTICTABLET, COATED503
68998-195-02Pain Relief PMExtra Strength1 in 1 CARTONTABLET, COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68998-195PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [MARC GLASSMAN, INC.]3Current NDC, Legacy NDC, 2 package rows20241025_e221bbce-83de-0f03-e053-2995a90abca5.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 48 of 79 · 1,561 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good sense pain reliefACETAMINOPHENBryant Ranch Prepackc226205d-7c3c-49af-b3e2-fc7b09ad78572025-02-05WarningsExact identifier
application number: M013
Dye Free Childrens AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharmaa69fca9d-c0a0-4321-bf03-5c8e99cc07cc2025-02-04WarningsExact identifier
application number: M013
TENSION HEADACHE RELIEFACETAMINOPHEN-CAFFEINETARGET CORPORATION8ed1679d-d3a1-11b1-e053-2995a90a61ad2025-01-31WarningsExact identifier
application number: M013
ValuMeds Extra Strength Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINECabinet Health P.B.C.0f864e73-e4b8-4e23-8990-8439ac17bd582025-01-31WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHEN TABLETS 500 MGWALGREENSc25bfe92-0196-0489-e053-2995a90abea12025-01-30WarningsExact identifier
application number: M013
Low dose AspirinASPIRIN 81 MG DELAYED RELEASE TABLETSWALGREENSc25c3524-3e24-3410-e053-2995a90a73ed2025-01-30WarningsExact identifier
application number: M013
HEADACHE RELIEFACETAMINOPHEN, ASPIRIN, CAFFEINEWALGREENSb5a45daa-05b1-4d6d-e053-2995a90a84442025-01-30WarningsExact identifier
application number: M013
Aspirin 81ASPIRINWALGREENSd71a571e-e2ce-7e0a-e053-2a95a90a53e02025-01-30WarningsExact identifier
application number: M013
Regular strength aspirinASPIRINTARGET CORPORATIONe8c87ccb-8c0c-7830-e053-2995a90a88b72025-01-30WarningsExact identifier
application number: M013
Multi-Symptom Menstrual ReliefACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATETARGET2368ac1b-d644-9908-e063-6394a90a4b892025-01-29WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENWalgreen Company28e275fb-d615-4725-998c-946fe1bfdc0c2025-01-29WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENMajor Pharmaceuticals38b839b6-de7d-4f33-a19a-efc92cdad92c2025-01-24WarningsExact identifier
application number: M013
good sense pain reliefACETAMINOPHENPreferred Pharmaceuticals Inc.523b68da-cd2a-4960-95e7-de5d51ce33c12025-01-23WarningsExact identifier
application number: M013
Safety Coated Aspirin 81 mg Low DoseASPIRIN 81MGUlai Health LLC3d225a11-a53b-4dc2-9c25-13cab007900f2025-01-20WarningsExact identifier
application number: M013
PharbetolACETAMINOPHEN 325 MGUlai Health LLC55bb7e6c-e98c-48bd-b7bb-9848ff0273ca2025-01-20WarningsExact identifier
application number: M013
ACETAMINOPHEN PMACETAMINOPHEN 500MG / DIPHENHYDRAMINE HCL 25MGUlai Health LLCd4a568c9-a721-48d1-aebc-fc65444947ce2025-01-20WarningsExact identifier
application number: M013
PharbetolACETAMINOPHEN 500MGUlai Health LLCc9d3cee1-531c-439f-ae19-07acd366aad62025-01-20WarningsExact identifier
application number: M013
Percogesic Original StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HCLMedtech Products Inc.529974c2-0121-4892-8e47-c2c4475810912025-01-17WarningsExact identifier
application number: M013
Little Remedies Childrens Fever Pain RelieverACETAMINOPHENMedtech Products Inc.e1e44c85-d10c-4997-8f85-064cda7906eb2025-01-17WarningsExact identifier
application number: M013
StanbackASPIRIN AND CAFFEINEMedtech Products Inc.caaa1313-09e4-45aa-8836-346f6a3701962025-01-17WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSNe221bbce-83de-0f03-e053-2995a90abca53
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCDe221bbce-83de-0f03-e053-2995a90abca53
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSYe221bbce-83de-0f03-e053-2995a90abca53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68998-195-02689980195021 BOTTLE, PLASTIC in 1 CARTON (68998-195-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2022-10-050000-00-00NoNoCurrent