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 73 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PANADOL ExtraACETAMINOPHEN AND CAFFEINEHaleon US Holdings LLCe5c2d88a-d903-4ca0-b895-f27e791dfc4e2024-02-06WarningsExact identifier
application number: M013
PANADOL Extra StrengthACETAMINOPHENHaleon US Holdings LLCb2fe7f47-1a2e-40ee-8f8f-38f2028dce1b2024-02-06WarningsExact identifier
application number: M013
PANADOL Extra StrengthACETAMINOPHENHaleon US Holdings LLC9d384e88-5c11-4600-ac6c-a383715701382024-02-06WarningsExact identifier
application number: M013
PANADOLACETAMINOPHENHaleon US Holdings LLC95801755-db54-4ad7-bec1-52671914f6ca2024-02-06WarningsExact identifier
application number: M013
PANADOL PMACETAMINOPHEN AND DIPHENHYDRAMINE HCLHaleon US Holdings LLC01e7dddb-755c-4745-b701-edcdb62090642024-02-06Warnings, Adverse reactionsExact identifier
application number: M013
PANADOL PMACETAMINOPHEN AND DIPHENHYDRAMINE HCLHaleon US Holdings LLCfe7cd1f2-9b00-4ded-99c2-8a152c71093c2024-02-06Warnings, Adverse reactionsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAptaPharma Inc.9064943f-836f-4853-b6f2-2c4879941eeb2024-02-02WarningsExact identifier
application number: M013
Quality Choice Effervescent Pain ReliefASPIRINCHAIN DRUG MARKETING ASSOCIATION, INC.079af5d7-1be8-2a93-e063-6294a90a496d2024-02-01WarningsExact identifier
application number: M013
MEDI-FIRST Non-AspirinACETAMINOPHENProficient Rx LP4c84948d-3a95-4c53-8529-7e7b9d8bb6df2024-02-01WarningsExact identifier
application number: M013
PharbetolACETAMINOPHENProficient Rx LP9c7d65e4-df2f-47c1-a185-66aaf19aad2b2024-02-01WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENProficient Rx LP57e4820c-b4eb-442e-9c49-93eedfbc5e5e2024-02-01WarningsExact identifier
application number: M013
good sense aspirinASPIRINProficient Rx LP73013074-9c6e-43c7-acde-4d9d8ed0133d2024-02-01WarningsExact identifier
application number: M013
MEDIQUE APAP Extra StrengthACETAMINOPHENProficient Rx LPc466a07f-2339-4cf5-8377-e0f109649c522024-02-01WarningsExact identifier
application number: M013
Percogesic Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINEMedtech Products Inc.2c5f1140-fb83-42c9-b0b1-5e2bd69340bb2024-02-01WarningsExact identifier
application number: M013
aspirinASPIRINProficient Rx LP3c7783a7-2b28-4968-b766-0a49dc70ce6d2024-02-01WarningsExact identifier
application number: M013
Regular Strength Pain ReliefACETAMINOPHENNuCare Pharmaceuticals,Inc.102bdcde-cb90-f248-e063-6394a90aac792024-01-30WarningsExact identifier
application number: M013
Excedrin Extra Strength HeadacheACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINEHaleon US Holdings LLC61802b27-c9ec-4386-9d44-45e8b1e558b72024-01-28WarningsExact identifier
application number: M013
AGRIFENACETAMINOPHEN, ASPIRIN, CAFFEINEOPMX LLC0fde22da-cdfc-36cc-e063-6294a90a38852024-01-26WarningsExact identifier
application number: M013
DOLODOLACETAMINOPHEN, ASPIRIN, CAFFEINEOPMX LLCe80536f1-92cc-5bb3-e053-2995a90a95402024-01-26WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINBryant Ranch Prepackd913d11f-c7a1-49d2-a2d3-9a29fc0328062024-01-18WarningsExact 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