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 firm2026-10-05

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 9 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin Low DoseASPIRINARMY AND AIR FORCE EXCHANGE SERVICEe273ead7-7cbc-4fd5-a136-9d3558a353602026-06-24WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENCVS PHARMACY5e35df92-6282-4ca6-902b-bb6bd326b4872026-06-23WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENOrelli Inc.4f9f1b4e-8bbb-49b9-8e6c-263edb2c084d2026-06-22WarningsExact identifier
application number: M013
Pain Relief Aspirin Chewable, Low DoseASPIRINRite Aid Corporation65cdce0f-be04-43ba-8c68-bdce7983cfa12026-06-22WarningsExact identifier
application number: M013
Aspirin RegimenASPIRINCardinal Health 110, LLC. DBA Leader88f425df-712d-4911-824b-94085c7190b62026-06-19WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINMeijer Distribution, Inc.3716a7d4-a555-4e54-aa0a-7b8f3e32addb2026-06-19WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDOLGENCORP, LLCacc94a3e-21b6-4375-9881-38cf9bab86922026-06-19WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINL.N.K. International, Inc.2f6ec676-3832-420e-be91-fce83f6586c82026-06-19WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEDOLGENCORP, LLCe1e24d52-0b4d-400b-8181-e3f6ab75c4f62026-06-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENOncor Pharmaceuticals4c396d0e-aa93-4f9e-b065-2e606f7f05cd2026-06-17WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINFamora Inc.4dc6f119-bbde-db5f-e063-6294a90a94862026-06-16WarningsExact identifier
application number: M013
Childrens Pain and Fever ReliefACETAMINOPHENChain Drug Marketing Association, Inc.420a1e05-caa6-481f-bdab-a670f0220f962026-06-16WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENDOLGENCORP, LLCce9f4e0d-43fb-499a-b8a2-a997a14841c42026-06-16WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENL.N.K. International, Inc.734cc3d2-6fc5-4dcc-93ed-0b57c1f013452026-06-15WarningsExact identifier
application number: M013
RIGHT REMEDIES EXTRA STRENGTH Pain Relief PM CapletACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.2d63671d-cf7c-bbdd-e063-6294a90affef2026-06-15WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC59773893-09a8-47a2-943a-e9ea9da4458a2026-06-15WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENShield Pharmaceuticals Corp.96eb7f9f-ff2d-4661-bbe6-1860aafe03f62026-06-15WarningsExact identifier
application number: M013
Duralgina Extra StrengthACETAMINOPHENMenper Distributors, Inc.544e3d7e-a759-384f-e063-6294a90a5baa2026-06-15WarningsExact identifier
application number: M013
pain relief childrensACETAMINOPHENRite Aid Corporationbe2286a1-946b-4bf5-b14c-8e86da6695942026-06-15WarningsExact identifier
application number: M013
Aspirin 81ASPIRINAmerisource Bergen4491faca-f30b-4eb0-bea9-f518f6b2f0952026-06-15WarningsExact 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