FDA.reportPublic FDA data

Acetaminophen 500mg

Product NDC
69168-011
11-digit product format
691680011
Labeler code
69168
Product ID
69168-011_13dbf279-c8b9-4a5c-8bed-0db001fe0c18
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen 500mg
Dosage form
TABLET
Route
ORAL
Labeler
Allegiant Health
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-04-15
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 84 · 1,678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relief Acetaminophen 325 mgACETAMINOPHENNUVICARE LLC49a59b79-b8b4-4bf5-a403-0a14751efc552026-07-30WarningsExact identifier
application number: M013
KinderFarms Childrens Pain and FeverACETAMINOPHENKinderFarms, LLC4f86419a-b940-a9c6-e063-6394a90a6a2b2026-07-30WarningsExact identifier
application number: M013
KinderFarms Infants Pain and FeverACETAMINOPHENKinderFarms, LLC5468b149-8fac-8d6a-e063-6294a90a8c512026-07-29WarningsExact identifier
application number: M013
AspirinASPIRINDolgencorp, Inc. (DOLLAR GENERAL & REXALL)3ba0a9f2-062a-401e-82eb-54383a8223662026-07-29WarningsExact identifier
application number: M013
Aspirin Low Dose ChewableASPIRINBetter Living Brands, LLC7afce7b4-c86a-43f7-83cf-15ebffba2f352026-07-28WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAurohealth LLCf818996c-36d2-4d3d-af3e-39949157edb92026-07-28WarningsExact identifier
application number: M013
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLL.N.K. International, Inc.03b871e8-3e14-4ed8-a978-45129255b2722026-07-27WarningsExact identifier
application number: M013
Pain Relief Acetaminophen PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HCLRite Aid Corporation17d27771-a112-474f-9a58-29af0d7e1af32026-07-27WarningsExact identifier
application number: M013
Children Pain Relief GummyACETAMINOPHEN CHILDREN GUMMYGummy USA5513db67-f023-7f47-e063-6294a90a27572026-07-24WarningsExact identifier
application number: M013
Infants TYLENOLACETAMINOPHENKenvue Brands LLC2143cc16-86db-4060-96da-5c228ae9207b2026-07-24WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENSoftgel Healthcare Pvt Ltd352bb451-ffdc-411a-e063-6294a90a8cf52026-07-24WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENNuCare Pharmaceuticals,Inc.fdb7331a-d029-8b2a-e053-6294a90adfcd2026-07-24WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAurohealth LLC5ada044e-50e8-4874-ac04-df5f1f9e735d2026-07-24WarningsExact identifier
application number: M013
childrens fever reducer and pain relieverACETAMINOPHENRite Aid Corporationa63727c3-64d8-4ae9-8da3-974cae6beed22026-07-24WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAurohealth LLCe4a2566e-48ec-4602-87e3-143398d15f332026-07-24WarningsExact identifier
application number: M013
infants fever reducer and pain relieverACETAMINOPHENRite Aid Corporation920e7055-7ed1-4db4-9215-f8933078bb7b2026-07-24WarningsExact identifier
application number: M013
Dye Free Pain and Fever ChildrensACETAMINOPHENWalgreensc6665c11-9a01-4472-a444-acadb1de0b692026-07-23WarningsExact identifier
application number: M013
Tylenol Extra StrengthACETAMINOPHENKenvue Brands LLC103d109d-f520-409c-8da2-eb6b0fbec8912026-07-22WarningsExact identifier
application number: M013
Tylenol PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCce58105b-f010-47af-8f31-6dd4ce4e9cba2026-07-22WarningsExact identifier
application number: M013
Vicks PainQuil PAIN RELIEVERACETAMINOPHENThe Procter & Gamble Manufacturing Company0ad7b313-5d72-4cc0-97f0-1a30770350af2026-07-22WarningsExact identifier
application number: M013

Additional Listing Data#

Finished product
Yes
Brand name base
Acetaminophen 500mg
Brand name suffix
ES
Listing expiration
2027-12-31

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
91acc132-01b6-467b-9af5-70f4dc93e087Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-011-24Acetaminophen 500mgES1 in 1 CARTONTABLET15
69168-011-24Acetaminophen 500mgES24 in 1 BOTTLETABLET245
69168-011-40Acetaminophen 500mgES40 in 1 BOTTLETABLET405
69168-011-40Acetaminophen 500mgES1 in 1 CARTONTABLET15
69168-011-50Acetaminophen 500mgES50 in 1 BOTTLETABLET505
69168-011-50Acetaminophen 500mgES1 in 1 CARTONTABLET15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-011ACETAMINOPHEN 500MG ES (ACETAMINOPHEN 500MG) TABLET [ALLEGIANT HEALTH]5Current NDC, Legacy NDC, 6 package rows20231115_91acc132-01b6-467b-9af5-70f4dc93e087.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN91acc132-01b6-467b-9af5-70f4dc93e0875
198440acetaminophen 500 MG Oral TabletSCD91acc132-01b6-467b-9af5-70f4dc93e0875
198440APAP 500 MG Oral TabletSY91acc132-01b6-467b-9af5-70f4dc93e0875

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69168-011-24691680011241 BOTTLE in 1 CARTON (69168-011-24) / 24 TABLET in 1 BOTTLE1 bottle2021-12-150000-00-00NoNoCurrent
69168-011-40691680011401 BOTTLE in 1 CARTON (69168-011-40) / 40 TABLET in 1 BOTTLE1 bottle2016-04-150000-00-00NoNoCurrent
69168-011-50691680011501 BOTTLE in 1 CARTON (69168-011-50) / 50 TABLET in 1 BOTTLE1 bottle2016-04-150000-00-00NoNoCurrent