FDA.reportPublic FDA data

Henry Schein Acetaminophen

Product NDC
0404-0716
11-digit product format
004040716
Labeler code
0404
Product ID
0404-0716_3e4c6e10-f9dd-1bca-e063-6294a90a78e1
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Henry Schein, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-12-30
Substance
ACETAMINOPHEN
Active strength
500 mg/1
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
Henry Schein Acetaminophen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198440Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a56a5ca1-578c-40cd-90cc-cc4c2dfec847Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-0716-13Henry Schein Acetaminophen250 in 1 BOXTABLET, FILM COATED25011
0404-0716-99Henry Schein Acetaminophen2 in 1 PACKETTABLET, FILM COATED211

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHENRY SCHEIN ACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [HENRY SCHEIN, INC.]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHENRY SCHEIN ACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [HENRY SCHEIN, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHENRY SCHEIN ACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [HENRY SCHEIN, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EHENRY SCHEIN ACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [HENRY SCHEIN, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHENRY SCHEIN ACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [HENRY SCHEIN, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHENRY SCHEIN ACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [HENRY SCHEIN, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHENRY SCHEIN ACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [HENRY SCHEIN, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-0716HENRY SCHEIN ACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [HENRY SCHEIN, INC.]10Current NDC, Legacy NDC, 2 package rows20241109_a56a5ca1-578c-40cd-90cc-cc4c2dfec847.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
198440acetaminophen 500 MG Oral TabletPSNa56a5ca1-578c-40cd-90cc-cc4c2dfec84711
198440acetaminophen 500 MG Oral TabletSCDa56a5ca1-578c-40cd-90cc-cc4c2dfec84711
198440APAP 500 MG Oral TabletSYa56a5ca1-578c-40cd-90cc-cc4c2dfec84711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-0716-1300404071613250 PACKET in 1 BOX (0404-0716-13) / 2 TABLET, FILM COATED in 1 PACKET (0404-0716-99) 250 packet2008-12-300000-00-00NoNoCurrent
0404-0716-99004040716992 TABLET, FILM COATED in 1 PACKET (0404-0716-99) 2008-12-300000-00-00NoNoCurrent