FDA.reportPublic FDA data

Acetaminophen and Diphenhydramine hydrochloride

Product NDC
30142-193
11-digit product format
301420193
Labeler code
30142
Product ID
30142-193_539e230b-aef0-4660-915d-b03b90d647d0
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Diphenhydramine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
KROGER COMPANY
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-06
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
Acetaminophen and Diphenhydramine hydrochloride
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
b9b86755-63ad-e25a-e053-2995a90ad747Available 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
30142-193-14Acetaminophen and Diphenhydramine hydrochloride1 in 1 CARTONTABLET15
30142-193-14Acetaminophen and Diphenhydramine hydrochloride50 in 1 BOTTLETABLET505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-193ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET [KROGER COMPANY]5Current NDC, Legacy NDC, 2 package rows20240926_b9b86755-63ad-e25a-e053-2995a90ad747.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 45 of 79 · 1,561 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
RIGHT REMEDIES LOW DOSE Aspirin 81mgASPIRINStrive Pharmaceuticals Inc.322c0e50-cf75-51ab-e063-6294a90a92352025-04-14WarningsExact 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
Arthriten Inflammatory Pain FormulaACETAMINOPHEN, ASPIRIN, CAFFEINEKobayashi Healthcare International, Incc280ca89-4fb5-4050-90ee-d706a550a1ef2025-04-11WarningsExact identifier
application number: M013
Bayer Back and Body Extra StrengthASPIRIN,CAFFEINEBayer HealthCare LLC.0c77c484-6caf-12ca-e054-00144ff88e882025-04-10WarningsExact identifier
application number: M013
Adult Low Dose Enteric Coated AspirinASPIRINNuCare Pharmaceuticals, Inc.324937c3-c558-bc79-e063-6294a90acc8e2025-04-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHEN 500MGCVS Pharmacy, Inc.1fde6487-6682-99a3-e063-6294a90a36702025-04-04WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENBryant Ranch Prepackbdc466c9-d9ae-4293-b7ea-46fb517661c62025-04-01WarningsExact identifier
application number: M013
Adult Low Dose Enteric Coated AspirinASPIRINGeri-Care Pharmaceutical Corpe327a52a-0e31-44b7-9823-7f60d070ae522025-04-01WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENProficient Rx LP9af5ccc8-aac0-4339-a9f6-58fdc9b91c572025-04-01WarningsExact identifier
application number: M013
ASPIRIN 325 MG ECASPIRINBryant Ranch Prepack9d0449d2-c0c6-4e74-931b-35dc625840282025-03-31WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINBryant Ranch Prepackcce1e8bd-63c8-403a-bc32-e6788493f6042025-03-31WarningsExact identifier
application number: M013
Adwe Feverx Acetaminophen Caplets, 500 mg Extra StrengthACETAMINOPHENAurex Laboratories Limited Liability Company948c5826-6f35-484d-bb3f-cecf6a4b5c132025-03-31WarningsExact identifier
application number: M013
Infants Pain and FeverACETAMINOPHENWALGREENS281a530b-c759-50eb-e063-6394a90abb4f2025-03-28WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLWR Group, Inc.8281771c-485c-42a9-9a1c-9a7a4298c5b82025-03-28WarningsExact identifier
application number: M013
Acetaminophen Regular strengthACETAMINOPHENPD-Rx Pharmaceuticals, Inc.4181efc2-d183-410c-b647-233444c57e322025-03-20WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSNb9b86755-63ad-e25a-e053-2995a90ad7475
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCDb9b86755-63ad-e25a-e053-2995a90ad7475
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSYb9b86755-63ad-e25a-e053-2995a90ad7475

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-193-14301420193141 BOTTLE in 1 CARTON (30142-193-14) / 50 TABLET in 1 BOTTLE1 bottle2021-03-060000-00-00NoNoCurrent