FDA.reportPublic FDA data

Acetaminophen

Product NDC
72162-2164
11-digit product format
721622164
Labeler code
72162
Product ID
72162-2164_ce0027c4-cd60-4e48-96ce-9a12a2113f40
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-09-12
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
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
b5053cf5-209d-4106-afc2-cf9af85f4a69Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2164-1Acetaminophen1 in 1 CARTONTABLET1101
72162-2164-1Acetaminophen100 in 1 BOTTLETABLET100101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2164ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]101Current NDC, 2 package rows20240601_b5053cf5-209d-4106-afc2-cf9af85f4a69.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 41 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good sense pain reliefACETAMINOPHENNuCare Pharmaceuticals,Inc.3c1f505d-0319-a179-e063-6294a90a0b172025-08-11WarningsExact identifier
application number: M013
AspirinASPIRINPROSTAT FIRST AID3bdb9d89-9000-69f9-e063-6294a90a0c972025-08-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENProstat First Aid3bdbea6a-3f11-9142-e063-6294a90a20ea2025-08-08WarningsExact identifier
application number: M013
Aspi-CorASPIRINL.N.K. International, Inc.9f919a48-ffd8-49fa-b6fd-ec71cc12e64b2025-08-08WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINA-S Medication Solutions8575ef9d-2eae-412a-a252-82b03f4d52752025-08-08WarningsExact identifier
application number: M013
AspirinASPIRINA-S Medication Solutions7a91b1df-8d6d-4205-9822-bc4d800555f72025-08-08WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENBryant Ranch Prepack3d6bf733-800c-420a-a9ab-ae4a261347992025-08-08WarningsExact identifier
application number: M013
AspirinASPIRINA-S Medication Solutions44b8c203-37c5-425e-9110-f7eb614f9c2d2025-08-08WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINCHAIN DRUG MARKETING ASSOCIATION INCc46688ec-e976-4f76-9265-645f59970ff52025-08-06WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEP & L Development, LLCc54ad829-f2e8-4367-b439-af20b0ef8ad22025-08-06WarningsExact identifier
application number: M013
TYLENOL Regular StrengthACETAMINOPHENKenvue Brands LLC398d8996-b522-a3cd-e063-6394a90ac2c82025-08-06WarningsExact identifier
application number: M013
AspirinASPIRINMarlex Pharmaceuticals Inc.cc7013ea-cf30-6f59-e053-2a95a90a11482025-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENProstat First Aid3ba313db-bafe-1947-e063-6294a90a528c2025-08-05WarningsExact identifier
application number: M013
MEDIQUE APAP acetaminophenMEDIQUE APAP ACETAMINOPHENHF Acquisition Co LLC, DBA HealthFirst3ba5c802-fe5a-e42a-e063-6394a90ae67e2025-08-05WarningsExact identifier
application number: M013
meijer EXTRA STRENGTH Pain Relief PM CAPLETACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEMeijer, Inc.376fed3b-7625-6379-e063-6394a90a188d2025-08-05WarningsExact identifier
application number: M013
CAREONE INFANTS ACETAMINOPHENACETAMINOPHENRetail Business Services, LLCb8024ec2-97c6-4aa1-b1dd-894164f488112025-08-04WarningsExact identifier
application number: M013
Exaprin PlusASPIRIN, ACETAMINOPHEN, CAFFEINEHART Health8a9ca680-e6cf-4ee4-8a5f-bd6d7470b8482025-08-04WarningsExact identifier
application number: M013
AspirinASPIRINProficient Rx LP2ef0757a-fe5f-47de-906a-a4d47a0d05342025-08-01WarningsExact identifier
application number: M013
Good Sense Pain ReliefACETAMINOPHENProficient Rx LPb4cb4a62-9ef7-4185-8770-e9a806c2fb3f2025-08-01WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENAAA Pharmaceutical, Inc.36ad21a3-6229-e91b-e063-6394a90a79332025-07-29WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNb5053cf5-209d-4106-afc2-cf9af85f4a69101
198440acetaminophen 500 MG Oral TabletSCDb5053cf5-209d-4106-afc2-cf9af85f4a69101
198440APAP 500 MG Oral TabletSYb5053cf5-209d-4106-afc2-cf9af85f4a69101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2164-1721622164011 BOTTLE in 1 CARTON (72162-2164-1) / 100 TABLET in 1 BOTTLE1 bottle2018-09-12NoNoCurrent