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 36 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TEXACLEAR PAIN RELIEVERCAFFEINE, CHOLINE SALICYLATEGM Pharmaceuticals, INC065bd10c-3bcf-486f-a49c-40544127007f2025-10-15WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENASCLEMED USA INC.db8e6702-88ac-4db2-9dd8-7d0ed997c2b52025-10-14WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENWalgreen Companyfa33f6ef-522b-4630-9716-92371d9cd24a2025-10-14WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENRite Aid Corporationa8bb4f45-7a1a-4bf7-92ca-3afd508032f32025-10-09WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENHealth Pharma USA LLCb15a7dcb-f143-4aea-8850-d0aacbf709b62025-10-09WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPD-Rx Pharmaceuticals, Inc.3f96aeb1-a533-4d36-9a1f-62fc094b67542025-10-08WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEWalgreensf2eb9575-d527-44c7-aa5e-efabfd9a02782025-10-07WarningsExact identifier
application number: M013
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLCHAIN DRUG MARKETING ASSOCIATION INCbbc704e5-79f6-4c72-846b-cc30c5c43cb42025-10-07WarningsExact identifier
application number: M013
Aspirin Enteric CoatedASPIRINCHAIN DRUG MARKETING ASSOCIATION INCf1ce15a3-9824-4eb5-910a-39078165f3852025-10-07WarningsExact identifier
application number: M013
BupropiDexDEXTROMETHORPHAN HYDROBROMIDEDXM Pharmacuetical, Inc.90cc9bcd-7891-4324-a1f4-f6df7a0457e02025-10-06WarningsExact identifier
application number: M013
DextabsDEXTROMETHORPHAN HYDROBROMIDEDXM Pharmacuetical, Inc.71b567df-844a-4563-b85a-f4592233f37d2025-10-06WarningsExact identifier
application number: M013
Acetaminophen, Aspirin and CaffeineACETAMINOPHEN, ASPIRIN AND CAFFEINERising Pharma Holdings, Inc.50f72713-50f5-4bab-9e96-b9fa73c9df1f2025-10-06WarningsExact identifier
application number: M013
OneSsip Acetaminophen Oral Suspension Bubble Gum 5 mLACETAMINOPHEN 160 MG / 5 MLMEDWISE LIFESCIENCES INC.40507559-aee4-a603-e063-6394a90afc4f2025-10-04WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENNuCare Pharmaceuticals,Inc.004c39cd-b4f4-1cae-e063-6394a90a06972025-10-03WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENFamily Dollar (FAMILY WELLNESS)43573e35-6776-446e-aa28-75c8edc5b98d2025-10-03WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENFamily Dollar (FAMILY WELLNESS)f8e5fab4-1212-4c60-a160-9b782f76a1982025-10-03WarningsExact identifier
application number: M013
CVS AcetaminophenACETAMINOPHENCVS Pharmacy3d71a0aa-5e03-0bdc-e063-6294a90a66342025-10-02WarningsExact identifier
application number: M013
Chewable AspirinASPIRINChain Drug Marketing Association, Inc.cc865351-34e8-4e8e-b8bf-23336c45bc612025-10-02WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENBryant Ranch Prepack8e40f8f1-03c5-444b-8b5e-4532c3146e472025-10-02WarningsExact identifier
application number: M013
ASPIRIN 325 MG ECASPIRINProficient Rx LP9f9355f7-024a-4adc-bb4c-2d9c0dd0cb772025-10-01WarningsExact 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