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 48 of 83 · 1,657 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACETAMINOPHENACETAMINOPHENAARNA USA INC.34157f6a-3031-4388-e063-6394a90a670f2025-05-01WarningsExact identifier
application number: M013
ASPIRINASPIRINHF Acquisition Co LLC, DBA HealthFirst2553d0cb-3f5c-7ea0-e063-6294a90a3cd42025-05-01Warnings, Adverse reactionsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENBi-Mart35483db0-d6b8-4b37-8113-1dbe51e42ae52025-05-01WarningsExact identifier
application number: M013
Aspirin 81mg Enteric CoatedASPIRINAdvanced Rx LLC606067bb-b07f-444e-9465-d1e187735f3a2025-05-01WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENAARNA USA INC.33f0e822-28af-9bb2-e063-6294a90a51752025-04-29WarningsExact identifier
application number: M013
Vicks PainQuil and Vicks PainQuil PM PAIN RELIEVERACETAMINOPHEN, DIPHENHYDRAMINE HCLThe Procter & Gamble Manufacturing Company334f3194-9737-8f85-e063-6394a90ad4162025-04-24WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENGeri-Care Pharmaceutical Corp27fcca07-f845-77fe-e063-6394a90aa2f82025-04-24WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENA-S Medication Solutions46a6bbb9-ccd1-47a8-9e58-485f71f570632025-04-24WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENA-S Medication Solutions061c91d5-5aa8-4556-a344-197b7e8a10b82025-04-24WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENA-S Medication Solutionsc4f0f591-8501-4c6d-bf8e-ca3068ff65b52025-04-24WarningsExact identifier
application number: M013
Extra Strength No-PainACETAMINOPHENSafrel Pharmaceuticals, LLC.873f01dd-0701-5fd3-e053-2a95a90a64632025-04-23WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENChain Drug Consortium60d4b392-6ed0-4115-8154-24eaf72504a52025-04-16WarningsExact identifier
application number: M013
Premsyn pms Premenstrual Pain ReliefACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATEFocus Consumer Healthcare, LLC5b6f6260-69ae-cfeb-e053-2a91aa0a6b492025-04-14WarningsExact identifier
application number: M013
BackAid MaxACETAMINOPHEN, PAMABROMKobayashi Healthcare International, Inc.fb9a5647-b7c9-4820-b148-91060e34cb832025-04-14WarningsExact identifier
application number: M013
DOLONEURO-TROPASACETAMINOPHEN, CAFFEINEOPMX LLC31bb39f4-3b7e-c983-e063-6294a90abccd2025-04-14WarningsExact identifier
application number: M013
RIGHT REMEDIES LOW DOSE Aspirin 81mgASPIRINStrive Pharmaceuticals Inc.322c0e50-cf75-51ab-e063-6294a90a92352025-04-14WarningsExact identifier
application number: M013
Aspirin 81mgASPIRINGendose Pharmaceuticals, LLC1d6552e8-4f89-411f-a352-8f7835851fc02025-04-11WarningsExact identifier
application number: M013
Bayer Aspirin Regimen Chewable Low Dose Aspirin OrangeASPIRINBayer HealthCare LLC.0c6ae05f-760f-34d1-e054-00144ff88e882025-04-11WarningsExact identifier
application number: M013
Vicks PainQuil PAIN RELIEVERACETAMINOPHENThe Procter & Gamble Manufacturing Company32841eaa-87ce-5f23-e063-6294a90a91182025-04-11WarningsExact identifier
application number: M013
Arthriten Inflammatory Pain FormulaACETAMINOPHEN, ASPIRIN, CAFFEINEKobayashi Healthcare International, Incc280ca89-4fb5-4050-90ee-d706a550a1ef2025-04-11WarningsExact 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