FDA.reportPublic FDA data

Acetaminophen

Product NDC
72036-104
11-digit product format
720360104
Labeler code
72036
Product ID
72036-104_5852bc1b-5799-ea43-e063-6394a90a73fa
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
HARRIS TEETER
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-12-01
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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 packagepackage72036-10472036-104-06DDiscontinued by firm2026-10-15

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
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
960f5676-d8c5-470b-a663-4b8d152339b4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72036-104-01Acetaminophen1 in 1 CARTONTABLET, COATED15
72036-104-01Acetaminophen24 in 1 BOTTLE, PLASTICTABLET, COATED245
72036-104-02Acetaminophen50 in 1 BOTTLE, PLASTICTABLET, COATED505
72036-104-02Acetaminophen1 in 1 CARTONTABLET, COATED15
72036-104-04Acetaminophen1 in 1 CARTONTABLET, COATED15
72036-104-04Acetaminophen100 in 1 BOTTLE, PLASTICTABLET, COATED1005
72036-104-06Acetaminophen500 in 1 BOTTLE, PLASTICTABLET, COATED5005
72036-104-08Acetaminophen150 in 1 BOTTLE, PLASTICTABLET, COATED1505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72036-104ACETAMINOPHEN TABLET, COATED [HARRIS TEETER]4Current NDC, Legacy NDC, 8 package rows20241024_960f5676-d8c5-470b-a663-4b8d152339b4.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 65 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
basic care acetaminophen pmACETAMINOPHEN, DIPHENHYDRAMINE HCLAmazon.com Services LLC64a0084a-e29e-4c1a-8704-13a3e1238f762024-07-17WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINWalmart Inc.152c013a-c81c-f8f9-e063-6294a90a9f232024-07-15WarningsExact identifier
application number: M013
Diphenhydramine HCLDIPHENHYDRAMINE HCLNuCare Pharmaceuticals, Inc.5411544e-3c2d-4e42-e054-00144ff8d46c2024-07-10WarningsExact identifier
application number: M013
good sense pain relief pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLL. Perrigo Companyb97c51ad-4953-4491-9ceb-395550eb52962024-07-10WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEWalgreens065e6f1b-f68c-491a-a157-84961a07e3d92024-07-10WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEWalgreens3b7b6725-2996-44d3-89a3-032384e7e2ce2024-07-10WarningsExact identifier
application number: M013
equate pain and fever infantsACETAMINOPHENWal-Mart Stores Inc8a152c8d-8ae0-4201-8bb9-7b22c35774152024-07-10WarningsExact identifier
application number: M013
Acetaminophen PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEWinCo Foods, LLC3c57498c-86b0-4ba3-881e-c742a2e8ece52024-07-09WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENWinCo Foods, LLCc358d1dd-9fcb-4d18-9521-8f898b98a7322024-07-09WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENWinCo Foods, LLC15430025-f25e-4fe7-b1fe-4eda4684081a2024-07-09WarningsExact identifier
application number: M013
Acetaminophen Easy Tabs Extra StrengthACETAMINOPHENWinCo Foods, LLC0631f003-4852-4034-a1c5-1552804b16602024-07-09WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINBryant Ranch Prepack61ecf3c9-42fa-4ae4-bd3b-694090477b9a2024-07-09WarningsExact identifier
application number: M013
Panadol Cold and Flu NonDrowsyACETAMINOPHEN AND PHENYLEPRINE HCLHaleon US Holdings LLCfa0ce51f-441d-4409-8617-b3402b00f1872024-07-08WarningsExact identifier
application number: M013
Pain and FeverACETAMINOPHENMeijer Distribution Inc81d4e8f5-2f15-462b-be71-ef05f0b791ab2024-07-05WarningsExact identifier
application number: M013
Extra Strength Pain ReliefACETAMINOPHENBryant Ranch Prepack31a97a6a-e5c8-429a-b497-330f0d84777d2024-07-05WarningsExact identifier
application number: M013
pain and feverACETAMINOPHENMeijer Distribution Inc375b2142-3c89-469c-98fd-bd4b63aeaa112024-07-05WarningsExact identifier
application number: M013
Best Choice Effervescent Pain Reliever 36ASPIRINVALU MERCHANDISERS COMPANY12f1278e-88b6-0460-e063-6394a90abf0e2024-07-03WarningsExact identifier
application number: M013
Topcare pain and feverACETAMINOPHENTopco Associates LLC950b16d5-65db-402d-8ec6-eec9e1e174dd2024-07-03WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENWALMART INC.16d5b56f-7e56-0c91-e063-6394a90a4b8e2024-07-03WarningsExact identifier
application number: M013
Acetaminophen and Diphenhydramine hydrochlorideACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEWALMART INC.16d5786c-2346-f970-e063-6394a90a0a8c2024-07-03WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN960f5676-d8c5-470b-a663-4b8d152339b45
198440acetaminophen 500 MG Oral TabletSCD960f5676-d8c5-470b-a663-4b8d152339b45
198440APAP 500 MG Oral TabletSY960f5676-d8c5-470b-a663-4b8d152339b45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72036-104-01720360104011 BOTTLE, PLASTIC in 1 CARTON (72036-104-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC2011-12-010000-00-00NoNoCurrent
72036-104-02720360104021 BOTTLE, PLASTIC in 1 CARTON (72036-104-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2011-12-010000-00-00NoNoCurrent
72036-104-04720360104041 BOTTLE, PLASTIC in 1 CARTON (72036-104-04) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2011-12-010000-00-00NoNoCurrent
72036-104-0672036010406500 TABLET, COATED in 1 BOTTLE, PLASTIC (72036-104-06) 2012-01-010000-00-00NoNoCurrent
72036-104-0872036010408150 TABLET, COATED in 1 BOTTLE, PLASTIC (72036-104-08) 2013-06-010000-00-00NoNoCurrent