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

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

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 1 of 85 · 1,681 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
childrens fever reducer and pain relieverACETAMINOPHENRite Aid Corporation7f445de3-30cf-4bd8-892d-05979cd399e72026-09-09WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINStrategic Sourcing Services LLC7ce4807e-7bd5-41f1-a9c7-1f3af6acdc092026-09-09WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENWal-Mart Stores Inc78874258-16cc-40b5-9e15-5943eddfce942026-09-08WarningsExact identifier
application number: M013
Pain and Fever ChildrensACETAMINOPHENDOLGENCORP, LLCc637b39c-a049-43af-a582-fc242e940d852026-09-08WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENWalgreen Companyf7667529-09c0-4603-8080-f236144fac362026-09-08WarningsExact identifier
application number: M013
UP AND UP CHILDRENS ACETAMINOPHENACETAMINOPHENTarget Corporatione2989ead-7fdc-4295-bf94-4231957756702026-09-08WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENRite Aid Corporationd846065a-5c39-4f4b-894c-4280acaaf4fa2026-09-08WarningsExact identifier
application number: M013
DESENFRIOL-ITO PLUSACETAMINOPHENOPMX LLC5ac41edd-e845-734d-e063-6294a90a990a2026-09-05WarningsExact identifier
application number: M013
DRX CHOICE Regular StrengthACETAMINOPHENRaritan Pharmaceuticals Inc.8bacb24a-24d0-4175-b3e0-05efb5f5d3732026-09-05WarningsExact identifier
application number: M013
MejoralitoACETAMINOPHENOPMX5a963a92-e29d-05ba-e063-6394a90a3a472026-09-03WarningsExact identifier
application number: M013
PentrexcilinaACETAMINOPHENOPMX LLC5a98e123-8e28-6732-e063-6394a90a010c2026-09-03WarningsExact identifier
application number: M013
infants pain and feverACETAMINOPHENCVS Pharmacy53b06c48-598e-41ad-ac7a-5508c195535c2026-09-03WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINCardinal Health 110, LLC. DBA Leader2777beea-06d7-4ff5-ae4a-ad7a117dfb622026-09-02WarningsExact identifier
application number: M013
AMAZON BASIC CARE ACETAMINOPHENACETAMINOPHENAmazon.com Services LLC113d92bf-f6c9-cc3d-e063-6294a90af0332026-09-02WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHENShield Pharmaceuticals Corp.78052120-40d8-4a3f-b72f-cc78ca76213b2026-09-02WarningsExact identifier
application number: M013
Adult Low Dose Chewable AspirinASPIRINFarmacias De Similares TX LLC513ea306-74c6-96e3-e063-6394a90a82622026-09-01WarningsExact identifier
application number: M013
Kroger Children Pain plus Fever chewablesACETAMINOPHENKROGER COMPANY83b5733c-70a1-4383-9729-2eb896d0149a2026-09-01WarningsExact identifier
application number: M013
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLTOP CARE (Topco Associates LLC)923b443d-73cc-4c52-92e4-a075786b1ae32026-09-01WarningsExact identifier
application number: M013
ACETAMINOPHEN PMACETAMINOPHEN, DIPHENHYDRAMINE HCLAmazon.com Services LLC99a137d6-07eb-43bc-b4b4-1a23041d595e2026-08-31WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENCVS PHARMACY64a1ebe7-af28-4b09-96e8-28fa4dcc52bd2026-08-31WarningsExact identifier
application number: M013

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