FDA.reportPublic FDA data

NDC 81033-002-10 - 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
81033-002-10
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 3 of 172 · 3,427 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen Extra StrengthACETAMINOPHENCVS PHARMACY64a1ebe7-af28-4b09-96e8-28fa4dcc52bd2026-08-31WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and Flu Multi Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corpe85b4c2a-d4e0-452c-9a08-fcc0ff6eaa212026-08-31WarningsExact identifier
unii: 362O9ITL9D
MAX relief junior GrapeCHILDRENS ACETAMINOPHENAkron Pharma Inc.cc769c26-556a-4831-bd75-61a7383aa7072026-08-31WarningsExact identifier
unii: 362O9ITL9D
MAX relief juniorCHILDRENS ACETAMINOPHENAkron Pharma Inc.ebb3b4ba-2d0b-48d9-b6ee-6d4696aea0472026-08-31WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corp67849e09-2056-4013-98b1-d003ed3250a22026-08-31WarningsExact identifier
unii: 362O9ITL9D
MAX relief juniorACETAMINOPHENAkron Pharma Inc.0e43b885-3843-4f11-9a53-02a38c2283132026-08-31WarningsExact identifier
unii: 362O9ITL9D
MAX relief juniorCHILDREN ACETAMINOPHENAkron Pharma Inc.d7874e4d-0b38-4bb1-9a62-aa4f66d9baf92026-08-31WarningsExact identifier
unii: 362O9ITL9D
MAX relief junior GrapeCHILDREN ACETAMINOPHENAkron Pharma Inc.3c7a7f40-4963-4fd1-942e-93fa08a458302026-08-31WarningsExact identifier
unii: 362O9ITL9D
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.5a615118-33c9-1520-e063-6394a90a21a62026-08-31WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFI24173e77-92ec-4a87-a471-d6867837c1802026-08-31WarningsExact identifier
unii: 362O9ITL9D
acetaminophen extra strengthACETAMINOPHENSam's West Incdd99efd0-4ca4-4dc6-a940-bebd17ac8f8d2026-08-28WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENREMEDYREPACK INC.464e404a-1957-44a2-a53a-f2a9d3c15bde2026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Multi-Symptom AllergyACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLWalgreen Company5170c450-989d-44fa-ab38-86c78feae3b62026-08-28WarningsExact identifier
unii: 362O9ITL9D
Pain Reliever PM Extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreens54cbbc5f-908b-47b2-b37f-3646354d35682026-08-27WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEREMEDYREPACK INC.40d4a71e-341e-48b3-b925-ba35b7910dff2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
major acetaminophenACETAMINOPHENMajor Pharmaceuticalsca9e1dae-eefb-4653-952f-2fde090596932026-08-27WarningsExact identifier
unii: 362O9ITL9D
daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEAmazon.com Services LLC6de619d3-0ab0-43e7-8dac-7bbd5368ac652026-08-27WarningsExact identifier
unii: 362O9ITL9D
Nighttime Cold and Flu Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCIWalgreens37896933-3ed3-457f-8a32-ee0d784a19e82026-08-27WarningsExact identifier
unii: 362O9ITL9D
equaline dual action pain relieverACETAMINOPHEN, IBUPROFENUnited Natural Foods, Inc. dba UNFIae0dc3f1-ee6f-4347-af5d-70f45dd68bdb2026-08-27WarningsExact identifier
unii: 362O9ITL9D
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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