FDA.reportPublic FDA data

equate pain relief pm

Product NDC
79903-421
11-digit product format
799030421
Labeler code
79903
Product ID
79903-421_7626ebea-c511-412f-99cc-86799de10054
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, diphenhydramine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
WALMART INC.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-29
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
1000; 50 mg/30mL; mg/30mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
equate pain relief pm
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN1000 mg/30mL
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/30mL

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
1092373Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
85129749-c1a7-4c4a-933f-c3c4768e2cddAvailable 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
79903-421-12equate pain relief pm355 mL in 1 BOTTLESOLUTION3552

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 32 of 83 · 1,657 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BAYER Aspirin Extra Strength CapletsBAYER ASPIRIN EXTRA STRENGTHBayer HealthCare LLC.0ae64cdb-4ea0-23af-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M013
Bayer Chewable - Aspirin Regimen Low Dose Aspirin Cherry FlavoredASPIRINBayer HealthCare LLC.070d5713-e018-2913-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M013
Bayer Low DoseASPIRINBayer HealthCare LLC.075b103e-0bb4-4b7a-ac0e-5645bcbd0a072025-12-04WarningsExact identifier
application number: M013
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATEBayer HealthCare LLC.5be36a7f-7d1f-468d-9c29-92c8cd3ef1bc2025-12-04WarningsExact identifier
application number: M013
Bayer Aspirin Regimen enteric coatedASPIRINBayer HealthCare LLC.0c6ae05f-7634-34d1-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M013
aspirin pain reliefASPIRINRite Aid Corporationae9d9977-7576-4894-8a32-454828abec9a2025-12-04WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEL.N.K. International, Inc.e51fc0d6-9b32-478c-bab7-328013e692b02025-12-04WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEMeijer Distribution Inc04f2c3ed-4bcf-4b6a-b8fb-0aa6ecb3dca22025-12-04WarningsExact identifier
application number: M013
ASPIRINASPIRINRMT HEALTH LLC2bacffd1-4870-73af-e063-6294a90a19c82025-12-02WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINERite Aid Corporationd9caee45-be43-45ec-927f-e7fec5c14f072025-12-02WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENMajor Pharmaceuticalse1a55e0d-bb86-4515-8436-51a74b4036852025-12-02WarningsExact identifier
application number: M013
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreen Companyb4d8860b-d72f-4789-945e-1c6420a8efab2025-12-02WarningsExact identifier
application number: M013
Infants Pain and FeverACETAMINOPHENWALGREEN COMPANYf7b304d8-e37c-4ac6-b4a2-1797b92cb8322025-12-01WarningsExact identifier
application number: M013
Dye FreeInfants Pain and FeverACETAMINOPHENWALGREEN COMPANY1a304570-88b6-4c16-a8b4-c064bfa5d95a2025-12-01WarningsExact identifier
application number: M013
Walgreen Severe Multi-Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWALGREENSb48d93fe-bb60-493f-8d1a-b2dc864203c42025-12-01WarningsExact identifier
application number: M013
Multi Symptom Severe Cold and Nighttime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWALGREEN CO.6c4ab613-a587-4ec4-9986-f1d000bc2d232025-12-01WarningsExact identifier
application number: M013
WAG HBP Daytime and Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEWALGREENS CO.ac2f9ce8-e402-4451-a412-e99248a6ecbe2025-12-01WarningsExact identifier
application number: M013
Walgreen Day Time NightTime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE,GUAIFENESINWALGREENS CO.5505217a-9679-4668-bdab-5d4553a47c562025-12-01WarningsExact identifier
application number: M013
Vicks PainQuil and Vicks PainQuil PM PAIN RELIEVERACETAMINOPHEN, DIPHENHYDRAMINE HCLThe Procter & Gamble Manufacturing Company163a1617-b7f1-4c80-e063-6394a90a74c32025-12-01WarningsExact identifier
application number: M013
CAREALL AspirinASPIRINNew World Imports, Inc58a371d4-1f00-4fda-8e08-80610c58505a2025-12-01WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092373acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG in 15 mL Oral SolutionPSN85129749-c1a7-4c4a-933f-c3c4768e2cdd2
1092373acetaminophen 33.3 MG/ML / diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD85129749-c1a7-4c4a-933f-c3c4768e2cdd2
1092373acetaminophen 1000 MG / diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY85129749-c1a7-4c4a-933f-c3c4768e2cdd2
1092373acetaminophen 500 MG / diphenhydramine HCl 25 MG per 15 ML Oral SolutionSY85129749-c1a7-4c4a-933f-c3c4768e2cdd2
1092373APAP 33.3 MG/ML / Diphenhydramine Hydrochloride 1.67 MG/ML Oral SolutionSY85129749-c1a7-4c4a-933f-c3c4768e2cdd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79903-421-1279903042112355 mL in 1 BOTTLE (79903-421-12) 355 ml2026-04-29NoNoCurrent