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 39 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Green Guard Extra Strength Pain ReliefASPIRIN. CAFFEINEUnifirst First Aid Corporatione729319a-6a2c-bfe6-e053-2a95a90a46202025-09-08WarningsExact identifier
application number: M013
Medique APAPACETAMINOPHENUnifirst First Aid Corporation04805d9c-d959-4870-a185-48b58a8808802025-09-08WarningsExact identifier
application number: M013
Green Guard Maximum Strength Non-AspirinACETAMINOPHENUnifirst First Aid Corporationf77c9554-d1c2-1682-e053-6294a90ac5722025-09-08WarningsExact identifier
application number: M013
Medique Back Pain ReliefMAGNESIUM SALICYLATE TETRAHYDRATEUnifirst First Aid Corporatione5563a0a-776a-83d4-e053-2a95a90a95002025-09-08WarningsExact identifier
application number: M013
MEDIQUE APAP Extra StrengthACETAMINOPHENUnifirst First Aid Corporation56822785-d5fb-4869-971e-5de637c2eda82025-09-08WarningsExact identifier
application number: M013
Medique Medi-Seltzer Pain ReliefASPIFINUnifirst First Aid Corporation3d593dee-b932-b611-e063-6294a90ad3b72025-09-08WarningsExact identifier
application number: M013
Medique Extra Strength APAPACETAMINOPHENUnifirst First Aid Corporationf77f8ef5-4aa8-fa80-e053-6394a90a70c22025-09-08WarningsExact identifier
application number: M013
Medique Pain OffACETAMINOPHEN, ASPIRIN, CAFFEINEUnifirst First Aid Corporationc2d7af6b-f477-2462-e053-2995a90aff0f2025-09-08WarningsExact identifier
application number: M013
Medique Extra Strength ApapACETAMINOPHENUnifirst First Aid Corporation14bcbaf9-76b6-f8ba-e063-6294a90a91f62025-09-08WarningsExact identifier
application number: M013
Crane Safety XS Non-AspirinACETAMINOPHEN 500 MGCrane Safety LLC9626b3b2-c8ba-5a58-e053-2995a90a35c82025-09-08WarningsExact identifier
application number: M013
Thompson AspirinASPIRINThompson9623d9c6-f241-bf4a-e053-2a95a90a4eb52025-09-08WarningsExact identifier
application number: M013
Thompson XS Pain AcheASPIRIN, CAFFEINEThompson Safetye87c2874-2a95-6839-e053-2a95a90ad14b2025-09-08WarningsExact identifier
application number: M013
Medique at Home APAPACETAMINOPHENUnifirst First Aid Corporationb5582e23-5079-1f2b-e053-2a95a90ad8002025-09-08WarningsExact identifier
application number: M013
Thompson Extra Strength Non-AspirinACETAMINOPHENThompsonf837c31f-24e5-a8df-e053-6394a90a0b362025-09-08WarningsExact identifier
application number: M013
Medique at Home APAP Extra StrengthACETAMINOPHEN 500 MGUnifirst First Aid Corporationb56b4110-fb8f-e5a0-e053-2995a90a0ad32025-09-08WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENP & L Development, LLC64c642b7-ef83-44b7-a014-6fa248dff3ba2025-09-08WarningsExact identifier
application number: M013
Extra Strength Acetaminophen PMACETAMINOPHEN, DIPHENHYDRAMINEBJWC (Berkley & Jensen / BJ's)2f473f1f-7cf3-2af5-e063-6394a90aaa172025-09-01WarningsExact identifier
application number: M013
foster and thrive rapid release pain reliefACETAMINOPHENStrategic Sourcing Services LLCd2130173-b107-4ae6-a1f7-6db467da38202025-08-30WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPrecision Dose, Inc.e1d4f562-433c-4344-9b77-1a7c731d1be52025-08-29WarningsExact identifier
application number: M013
Aspirin Enteric Coated Low DoseASPIRINWalgreen Companyb11a4c4e-374c-403e-a757-5e9700f9f03b2025-08-27WarningsExact 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