FDA.reportPublic FDA data

Henry Schein Acetaminophen

Product NDC
0404-0714
11-digit product format
004040714
Labeler code
0404
Product ID
0404-0714_3e4c6f6c-2c41-2312-e063-6394a90a03f3
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
325 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
ACETAMINOPHEN325 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
313782Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f43f72de-ff79-4c7e-bd1e-3f0c4c3872faAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-0714-13Henry Schein Acetaminophen2 in 1 PACKETTABLET, FILM COATED210
0404-0714-13Henry Schein Acetaminophen250 in 1 BOXTABLET, FILM COATED25010
0404-0714-99Henry Schein Acetaminophen2 in 1 PACKETTABLET, FILM COATED210

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
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AHENRY 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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-0714HENRY SCHEIN ACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [HENRY SCHEIN, INC.]9Current NDC, Legacy NDC, 3 package rows20241109_f43f72de-ff79-4c7e-bd1e-3f0c4c3872fa.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 15 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin 81 mg Low DoseASPIRINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED23b29044-6389-42ea-839a-5351557a6ce32026-04-23WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED4a70867e-481d-4f01-9da3-d85663a1672e2026-04-23WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINUnited Natural Foods, Inc. dba UNFI07edcb31-d31d-4607-98c3-dcb1e062cc702026-04-22WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCardinal Health 107, LLCee50c5ee-1a61-4efc-aca9-42d897d6a3b82026-04-22WarningsExact identifier
application number: M013
AspirinASPIRINCVS PHARMACY904a2b21-d911-40c3-9e4b-59543ea5be4f2026-04-22WarningsExact identifier
application number: M013
Pamprin Multi-Symptom Maximum StrengthACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATEFocus Consumer Healthcare, LLC60b3286d-5698-df50-e053-2991aa0afbe22026-04-20WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENCVS PHARMACYaf6fe4a9-2d18-4fed-b952-0a7866f652512026-04-20WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINPreferred Pharmaceuticals Inc.ac7f11d2-cbfd-4610-a652-fc2f1ea41d7e2026-04-20WarningsExact identifier
application number: M013
Parry-500mg AcetaminophenACETAMINOPHENMDC PHARMACEUTICALS LIMITEDfb07ba10-3210-41bc-9310-c952118fdcf32026-04-17WarningsExact identifier
application number: M013
Aspirin NSAIDASPIRINValu Merchandisers Company0cc46a81-54c9-44b7-b384-79d25255eff22026-04-17WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINEValu Merchandisers Company99de2c41-59b0-42e7-847e-e51229c6164f2026-04-17WarningsExact identifier
application number: M013
Pain and Fever ChildrensACETAMINOPHENWalgreen Company1f3e2895-5ef7-4e6a-8d2e-b805d148f9802026-04-16WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLCb297aff8-a08b-4d37-b168-800a56564cbd2026-04-16WarningsExact identifier
application number: M013
Childrens TylenolACETAMINOPHENKenvue Brands LLC9782fe86-d72a-4231-b1ba-d3f3b4ee49e32026-04-16WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HCLDOLGENCORP, LLC8e65478b-7a7b-416c-b8e3-23dad79f8cc12026-04-16WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINValu Merchandisers Companyc9e384e5-fa9b-4c75-b5e3-16eb8db662ef2026-04-16WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPreferred Pharmaceuticals Inc.b6abfbbb-9826-4cd6-940f-3a314480a5a52026-04-15WarningsExact identifier
application number: M013
Good Sense Pain and FeverACETAMINOPHENL. Perrigo Companyf7137fe6-582e-43a4-8302-90ca54cd1de32026-04-14WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCardinal Health 107, LLCe13656eb-513e-411e-bdae-35ff1ba7cfc12026-04-13WarningsExact identifier
application number: M013
CareOne AcetaminophenACETAMINOPHENAmerican Sales Companyb4f54465-3232-4685-9570-90be008765772026-04-12WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313782acetaminophen 325 MG Oral TabletPSNf43f72de-ff79-4c7e-bd1e-3f0c4c3872fa10
313782acetaminophen 325 MG Oral TabletSCDf43f72de-ff79-4c7e-bd1e-3f0c4c3872fa10
313782APAP 325 MG Oral TabletSYf43f72de-ff79-4c7e-bd1e-3f0c4c3872fa10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-0714-1300404071413250 PACKET in 1 BOX (0404-0714-13) / 2 TABLET, FILM COATED in 1 PACKET250 packet2008-12-300000-00-00NoNoCurrent
0404-0714-99004040714992 TABLET, FILM COATED in 1 PACKET (0404-0714-99) 2008-12-300000-00-00NoNoCurrent