FDA.reportPublic FDA data

Acetaminophen, Diphenhydramine Hydrochloride

Product NDC
70000-0411
11-digit product format
700000411
Labeler code
70000
Product ID
70000-0411_4bbe57b4-c0c6-c37f-e063-6294a90a7dd7
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
LEADER/ Cardinal Health 110, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-11-29
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
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
Acetaminophen, Diphenhydramine Hydrochloride
Listing expiration
2027-12-31

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
7be4d67e-1af9-f059-e053-2991aa0a382eAvailable 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
70000-0411-1Acetaminophen, Diphenhydramine Hydrochloride1 in 1 CARTONTABLET, FILM COATED17
70000-0411-1Acetaminophen, Diphenhydramine Hydrochloride24 in 1 BOTTLETABLET, FILM COATED247
70000-0411-2Acetaminophen, Diphenhydramine Hydrochloride50 in 1 BOTTLETABLET, FILM COATED507
70000-0411-3Acetaminophen, Diphenhydramine Hydrochloride1 in 1 CARTONTABLET, FILM COATED17
70000-0411-3Acetaminophen, Diphenhydramine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0411-1EA - Each70000-041115fd30a1-2ad7-436f-be92-9b92e7c98b6712019-08-06
70000-0411-2EA - Each70000-041138d72d75-ca00-495d-ba2f-f47c8f99fd2112019-08-06
70000-0411-3EA - Each70000-041188c57048-0046-45d5-8256-8d2dfb5493ff12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0411ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [LEADER/ CARDINAL HEALTH 110, INC.]6Current NDC, Legacy NDC, 5 package rows20250212_7be4d67e-1af9-f059-e053-2991aa0a382e.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 8 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AspirinASPIRINUnited Natural Foods, Inc. dba UNFI19c7f832-d7ec-4dcc-8aa4-f4cbf64c9ff62026-07-02WarningsExact identifier
application number: M013
pain relief EXTRA STRENGTHACETAMINOPHENMeijer Distribution, Inc.ae84eb7e-a70b-4311-b2dc-ad153047a5162026-07-01WarningsExact identifier
application number: M013
Aspirin 325 mgASPIRINHi-Tech Nutraceuticals, LLCb3426a9a-ea99-da30-e053-2995a90a1e4b2026-07-01WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINESalado Sales, Inc.ca21d576-be3c-495d-9dbd-ed514bf65da72026-07-01WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENMeijer Distribution Inc4e08a7cb-3894-84c3-e063-6394a90a0b422026-06-30WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINEWal-Mart Stores Inc9b1201af-c802-4e19-b192-bbbf34367db42026-06-30WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENP & L Development, LLCfc841cba-8f4f-407b-97de-0422977515bd2026-06-30WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEUnited Natural Foods, Inc. dba UNFIb6ff2b34-51ee-41bc-8b7d-7520ade0bf362026-06-30WarningsExact identifier
application number: M013
MedlineASPIRINMedline Industries, LP4b0c569a-ed7a-e104-e063-6394a90a6d542026-06-29WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLWALMART INC.e50b3f60-b827-426c-8e78-8447c89130fe2026-06-29WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN, DIPHENHYDRAMINE HCLChain Drug Marketing Association, Inc.e58417f4-3575-4433-ac2e-b7bf9fe8ba102026-06-29WarningsExact identifier
application number: M013
Dr Kids Pain and FeverACETAMINOPHENCalmCo LLC5534a784-a7b1-5599-e063-6294a90a79612026-06-27WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENSelect Consumer Group LLC529d3a51-a248-7c02-e063-6294a90a10ae2026-06-27WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENSportpharm LLC830ffcaa-7ff8-4732-bc84-6a8c5e78722d2026-06-25WarningsExact identifier
application number: M013
AspirinASPIRINStrategic Sourcing Services LLCea2ef485-429e-4c63-ba7b-0a6b32892ad22026-06-25WarningsExact identifier
application number: M013
AspirinASPIRINChain Drug Marketing Association, Inc.055d8420-c189-4a9e-acdc-21627935c8eb2026-06-25WarningsExact identifier
application number: M013
AspirinASPIRINTopco Associates, LLC5f32cf74-dbea-496c-ba23-2040ea354f402026-06-25WarningsExact identifier
application number: M013
AspirinASPIRINSalado Sales, Inc.cf3139a5-e36e-48e3-bb6c-e102b0cec5552026-06-25WarningsExact identifier
application number: M013
Pain Relief AspirinASPIRINRite Aid Corporationbd69d3d2-5d38-47c6-98a6-124f7a43b8b02026-06-25WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINWalgreen Company0b27c0fd-7ea8-4588-9169-5ad4e8df77ef2026-06-25WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN7be4d67e-1af9-f059-e053-2991aa0a382e7
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD7be4d67e-1af9-f059-e053-2991aa0a382e7
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY7be4d67e-1af9-f059-e053-2991aa0a382e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0411-1700000411011 BOTTLE in 1 CARTON (70000-0411-1) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-12-100000-00-00NoNoCurrent
70000-0411-27000004110250 TABLET, FILM COATED in 1 BOTTLE (70000-0411-2) 2018-11-290000-00-00NoNoCurrent
70000-0411-3700000411031 BOTTLE in 1 CARTON (70000-0411-3) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-12-100000-00-00NoNoCurrent