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 35 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Goodys Cool Orange HeadacheACETAMINOPHEN AND ASPIRIN AND CAFFEINEMedtech Products Inc.31212c97-9975-427e-bc3d-f7125f30299a2025-10-23WarningsExact identifier
application number: M013
BC ArthritisASPIRIN AND CAFFEINEMedtech Products Inc.3a85be2d-6548-4de5-8109-60e1ca2bfca32025-10-23WarningsExact identifier
application number: M013
Goodys Extra StrengthACETAMINOPHEN, ASPIRIN, AND CAFFEINEMedtech Products Inc.d4325b17-23bc-44ac-868d-bb0886853a732025-10-23WarningsExact identifier
application number: M013
BCASPIRIN AND CAFFEINEMedtech Products Inc.226173d4-b6d5-4fe6-b24e-1cc5d1b31c882025-10-23WarningsExact identifier
application number: M013
BC MAXASPIRIN, ACETAMINOPHEN, CAFFEINEMedtech Products Inc.1e2a07ab-23e6-49b4-a676-212dc6880f142025-10-23WarningsExact identifier
application number: M013
Ecotrin Regular StrengthASPIRINMedtech Products Inc.36cb530b-25b2-4f62-a25d-aa04360815a82025-10-23WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENTOPCO ASSOCIATES LLCbbc367cc-6c79-498e-8fca-1347e6ea1a8c2025-10-22WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRugby Laboratoriesb16ed4ef-689c-4df2-ab6c-207aa8b9925d2025-10-22WarningsExact identifier
application number: M013
Tension Headache ReliefACETAMINOPHEN, CAFFEINETIME CAP LABS INC05364eb4-07a1-a4d9-e063-6294a90a47e52025-10-21WarningsExact identifier
application number: M013
Acetaminophen, Aspirin, CaffeineACETAMINOPHEN, ASPIRIN, CAFFEINECVS Pharmacy, Inc.6deb854f-863e-24ad-e053-2991aa0afb172025-10-21WarningsExact identifier
application number: M013
BackAidACETAMINOPHEN, CAFFEINEKobayashi Healthcare International, Inc.25db6bb5-96b6-4be1-e063-6294a90a23002025-10-21WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENMethod Pharmaceuticals, LLC1539dc44-15a0-153b-e063-6294a90a9d452025-10-21WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENMethod Pharmaceuticals, LLC3d1bb61c-15db-4eba-aba9-cfbcbc7b30e02025-10-21WarningsExact identifier
application number: M013
Walgreens Antacid Pain Relief Extra StrengthASPIRIN, CITRIC ACID, SODIUM BICARBONATEWalgreensb60df498-07db-500b-e053-2a95a90aff6a2025-10-17WarningsExact identifier
application number: M013
Equate Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEWalmart6271b34b-55a0-40a8-e053-2a91aa0acb222025-10-17Warnings, Adverse reactionsExact identifier
application number: M013
Xesso NeoBENZOCAINEPREMIUM NATURAL COSMETICS INC163f32cd-4e51-950a-e063-6394a90a48162025-10-17WarningsExact identifier
application number: M013
Menstrual Complete Maximum StrengthACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATECHAIN DRUG MARKETING ASSOCIATION INC913d8bdb-7644-464c-b9a6-55387ff120592025-10-17WarningsExact identifier
application number: M013
Alka-Seltzer Hangover ReliefANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATEBayer HealthCare LLC.dc235b06-999e-221d-e053-2a95a90a0ce12025-10-16WarningsExact identifier
application number: M013
Aspirin 81mgASPIRIN ENTERIC COATED TABLETS 81MGVITANE PHARMACEUTICALS, INC41386de5-5857-efab-e063-6294a90afd9c2025-10-15WarningsExact identifier
application number: M013
Aspirin 81mgASPIRIN ENTERIC COATED TABLETS 81MGVITANE PHARMACEUTICALS, INC4138d4c0-baa5-1f20-e063-6394a90a788f2025-10-15WarningsExact 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