FDA.reportPublic FDA data

NDC 81033-002-05 - Acetaminophen

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
81033-002
Requested NDC
81033-002-05
Package NDCs from labels
81033-002-10, 81033-002-40, 81033-002-05, 81033-002-50, 81033-002-20, 81033-002-30, 81033-002-55, 81033-002-54, 81033-002-53
Manufacturer
Kesin Pharma Corporation
Effective date
2024-12-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Acetaminophen - Kesin Pharma CorporationKesin Pharma Corporation2024-12-03HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
81033-002-312024-12-025mL, 10.15mL, 20.3mL, ACETAMINOPHEN oral solution 160mg per 5mL, 10.15mL
81033-002-412024-12-025mL, 10.15mL, 20.3mL, ACETAMINOPHEN oral solution 160mg per 5mL, 10.15mL
81033-002-512024-12-025mL, 10.15mL, 20.3mL, ACETAMINOPHEN oral solution 160mg per 5mL, 10.15mL
81033-002-312024-07-305mL, 10.15mL, 20.3mL, ACETAMINOPHEN oral solution 160mg per 5mL, 10.15mL
81033-002-412024-07-305mL, 10.15mL, 20.3mL, ACETAMINOPHEN oral solution 160mg per 5mL, 10.15mL
81033-002-512024-07-305mL, 10.15mL, 20.3mL, ACETAMINOPHEN oral solution 160mg per 5mL, 10.15mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81033-002-05Acetaminophen5 mL in 1 CUP, UNIT-DOSESOLUTION56
81033-002-10Acetaminophen10.15 mL in 1 CUP, UNIT-DOSESOLUTION10.156
81033-002-20Acetaminophen20.3 mL in 1 CUP, UNIT-DOSESOLUTION20.36
81033-002-30Acetaminophen30 in 1 CARTONSOLUTION306
81033-002-40Acetaminophen40 in 1 CARTONSOLUTION406
81033-002-50Acetaminophen50 in 1 CARTONSOLUTION506
81033-002-53Acetaminophen100 in 1 CARTONSOLUTION1006
81033-002-54Acetaminophen100 in 1 CASESOLUTION1006
81033-002-55Acetaminophen100 in 1 CASESOLUTION1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81033-002ACETAMINOPHEN SOLUTION [KESIN PHARMA CORPORATION]6Legacy NDC, 9 package rows20241207_c5b3c78c-9148-bf69-e053-2995a90aba65.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-002-05ML - Milliliter81033-002df084a20-976d-4893-9f0f-849d2e7b51a112021-09-07
81033-002-10ML - Milliliter81033-002c1391bb6-7477-4b6b-9088-e3d4c5843aa412021-09-07
81033-002-20ML - Milliliter81033-002fa827bdc-75a9-4525-b5f0-2bd4661f862012021-09-07
81033-002-30ML - Milliliter81033-002d7d18747-ccf6-4c7c-adb1-c02ec2d074e412021-09-07
81033-002-40ML - Milliliter81033-00228471a82-9d8a-46db-909a-9c6c417310f012021-09-07
81033-002-50ML - Milliliter81033-0027c72bb51-3d41-49ee-949d-30db6a6c538d12021-09-07
81033-002-53ML - Milliliter81033-0021584efa3-0e43-4654-9a46-715327b6572412024-12-10
81033-002-54ML - Milliliter81033-00210c3e057-6d8b-478f-bb67-a76ee650b49d12024-12-10
81033-002-55ML - Milliliter81033-002cb745b34-eb89-44a4-90dd-b68ab58c0ecb12024-12-10

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 172 · 3,427 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEPAI Holdings, LLC dba PAI Pharma95ac6875-6b14-4cde-8efb-80704e39b8d82026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Acetaminophen, Dextromethorphan HBrACETAMINOPHEN, DEXTROMETHORPHAN HBRNUVICARE LLC6713fdff-0e4e-4a9d-b218-34f786339c572026-08-06WarningsExact identifier
unii: 362O9ITL9D
Tension Headache Aspirin-FreeACETAMINOPHEN, CAFFEINERite Aid Corporation093a7c26-f2b1-4416-b193-81133d247d2e2026-08-06WarningsExact identifier
unii: 362O9ITL9D
Menstrual Relief Maximum StrengthACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATEARMY AND AIR FORCE EXCHANGE SERVICE8282cb5a-6c38-4500-93bb-461e4d65df1c2026-08-05WarningsExact identifier
unii: 362O9ITL9D
TOPCARE DAY TIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDETopco Associates LLCd1b89d17-b3b9-4133-88a3-8cd7c4efafa92026-08-05WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHENACETAMINOPHENKroger Companybc17b2e5-4828-6a2e-e053-2995a90a8c632026-08-05WarningsExact identifier
unii: 362O9ITL9D
Infants TYLENOLACETAMINOPHENKenvue Brands LLC997b9551-c222-4a9c-8ba1-09a5f97495fa2026-08-05WarningsExact identifier
unii: 362O9ITL9D
ALKA SELTZER COLD Cold Flu and Congestion Fast DissolveCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.507284c3-cad9-d65c-e063-6394a90a58a82026-08-05WarningsExact identifier
unii: 362O9ITL9D
Mantra Pain Gel raspberryACETAMINOPHENMOREMED INC.7c8bdf49-a6d2-4e42-b006-375f103fd0ac2026-08-05WarningsExact identifier
unii: 362O9ITL9D
Mantra Menstrual Pain Gel strawberryACETAMINOPHEN, PAMABROMMOREMED INC.22291ca3-04c0-4386-8001-aa9bb45d7f3b2026-08-05WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENHARRIS TEETERd2d2846d-4e0b-4d42-b300-60dd3b2cca1b2026-08-05WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENHARRIS TEETER960f5676-d8c5-470b-a663-4b8d152339b42026-08-05WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENHARRIS TEETERa60f6439-2033-4bd2-b78c-6c083414a12b2026-08-05WarningsExact identifier
unii: 362O9ITL9D
pain relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHARRIS TEETER0afb6181-d0b1-4845-8230-faabf1b997dc2026-08-05WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHarris Teeter8a3e3439-90ae-4fc9-8ff2-44b8363fa3382026-08-05WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENHarris Teeter50e7b939-e0eb-44ea-82ea-034e844e2c292026-08-05WarningsExact identifier
unii: 362O9ITL9D
8HR Arthritis PainACETAMINOPHENHARRIS TEETERbfee9b3e-0c50-7c10-e053-2995a90af2fe2026-08-05WarningsExact identifier
unii: 362O9ITL9D
Migraine ReliefACETAMINOPHEN, ASPIRIN AND CAFFEINEHARRIS TEETERff32572c-393b-0b49-e053-6394a90a83da2026-08-05WarningsExact identifier
unii: 362O9ITL9D
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
unii: 6DC9Q167V3
CareOne Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerican Sales Companyc9342ad2-84dc-4f4c-9b05-c6e5c1c7989e2026-08-04WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.