Acetaminophen

Product NDC
0536-1172
11-digit product format
005361172
Labeler code
0536
Product ID
0536-1172_0eaf3569-5e07-f353-e063-6294a90a4150
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Rugby Laboratories
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-10-01
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0536-11720536-1172-10DDiscontinued by firm2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0536-11720536-1172-10DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Additional Listing Data#

Finished product
Yes
Brand name base
Acetaminophen
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
76f10ee2-1d6a-097c-e053-2991aa0af526Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1172-01Acetaminophen100 in 1 BOTTLETABLET1003
0536-1172-10Acetaminophen1000 in 1 BOTTLETABLET10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1172-01EA - Each0536-1172f30304ac-97a9-421a-a77c-c731f4437d2512018-11-06
0536-1172-10EA - Each0536-11726e2522e7-6495-4491-b77c-0a609723c21b12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1172ACETAMINOPHEN TABLET [RUGBY LABORATORIES]3Current NDC, Legacy NDC, 2 package rows20240112_76f10ee2-1d6a-097c-e053-2991aa0af526.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 TabletPSN76f10ee2-1d6a-097c-e053-2991aa0af5263
198440acetaminophen 500 MG Oral TabletSCD76f10ee2-1d6a-097c-e053-2991aa0af5263
198440APAP 500 MG Oral TabletSY76f10ee2-1d6a-097c-e053-2991aa0af5263

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1172-0100536117201100 TABLET in 1 BOTTLE (0536-1172-01) 100 tablet2018-10-010000-00-00NoNoCurrent
0536-1172-10005361172101000 TABLET in 1 BOTTLE (0536-1172-10) 1000 tablet2018-10-010000-00-00NoNoCurrent