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 7 of 172 · 3,427 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Oxycodone Hydrochloride and AcetaminophenOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy40a68a27-4422-5ba0-e063-6294a90ac5502026-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Theraflu Relief Max Strength NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBRCVS PHARMACY4b567234-1da9-4e10-a427-877eea2be1c12026-08-14WarningsExact identifier
unii: 362O9ITL9D
CVS Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS PHARMACY87d4cfc0-c7b4-42c0-bfa9-96e124e32ed32026-08-14WarningsExact identifier
unii: 362O9ITL9D
CVS Severe Multi-Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS PHARMACYbb24c298-1d00-4378-8de3-b4056220fa752026-08-14WarningsExact identifier
unii: 362O9ITL9D
Theraflu Relief Max Strength DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY932a3d40-9b52-4e91-bc61-6fd506f2d9e62026-08-14WarningsExact identifier
unii: 362O9ITL9D
CVS Severe Cough, Flu Plus Sore Throat HoneyACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY95203001-7ca6-4513-83a3-9ef17855bc0f2026-08-14WarningsExact identifier
unii: 362O9ITL9D
CVS Childrens Pain plus Fever ReliefACETAMINOPHENCVS PHARMACY22a48a33-995b-481e-9e4e-1ad7ec346f442026-08-14WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS PHARMACY81d26e9c-b713-4fb3-b0a5-68526bad230e2026-08-14WarningsExact identifier
unii: 362O9ITL9D
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmazon.com Services LLC212acd54-6ff0-446a-a3bb-3b40e12797112026-08-13WarningsExact identifier
unii: 362O9ITL9D
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreen Companye9d0b6f9-e9f3-431c-9f34-4d63108282a12026-08-13WarningsExact identifier
unii: 362O9ITL9D
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINECVS Pharmacy31ccc867-ca83-70a9-f3d5-5644030047b82026-08-13WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmazon.com Services LLC1e3c81b0-05de-4c4a-8579-f301f14626b32026-08-13WarningsExact identifier
unii: 362O9ITL9D
Pain ReliefACETAMINOPHENTopco Associates, LLC8b9e90da-98e2-4d8d-bf6e-54b0a8f8d1012026-08-12WarningsExact identifier
unii: 362O9ITL9D
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLCf95220c5-e55c-4271-a267-d004ad2447bf2026-08-12WarningsExact identifier
unii: 362O9ITL9D
Gencare- Pain Relief AcetaminophenACETAMINOPHENPioneer Life Sciences, LLC2111c91b-2fd7-4ab3-946a-d4e0cf46399a2026-08-12WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)af35c833-316a-4d21-bd3a-9b71558cadbf2026-08-12WarningsExact identifier
unii: 362O9ITL9D
Pain Reliever Extra StrengthACETAMINOPHENSalado Sales, Inc.1dbd8480-5cb4-4577-9091-b2a2add4f1af2026-08-12WarningsExact identifier
unii: 362O9ITL9D
pain relief childrensACETAMINOPHENRite Aid Corporation29ecdd2d-aeaf-40a8-a347-011088009ea62026-08-11WarningsExact identifier
unii: 362O9ITL9D
Fast Acting Pedia CraeACETAMINOPHENRandob Labs., Ltd.e069060f-fbb2-4c7a-b872-00b3ab86d01b2026-08-11WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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