FDA.reportPublic FDA data

NDC 68094-042-01 - 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
68094-042
Requested NDC
68094-042-01
Package NDCs from labels
68094-042-01, 68094-042-58
Manufacturer
Precision Dose, Inc.
Effective date
2024-12-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Acetaminophen Oral SuspensionPrecision Dose, Inc.2024-12-04HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68094-042-01Acetaminophen2.5 mL in 1 SYRINGE, PLASTICSUSPENSION2.51
68094-042-58Acetaminophen10 in 1 BAGSUSPENSION101
68094-042-58Acetaminophen5 in 1 CASESUSPENSION51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-042ACETAMINOPHEN SUSPENSION [PRECISION DOSE, INC.]1Current NDC, 3 package rows20250113_5a68ab98-720c-479a-a60a-4e594add6c09.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-042-01ML - Milliliter68094-0427ec21617-9121-4b43-b3d5-d0fee46ed4ea12025-03-04
68094-042-58ML - Milliliter68094-042bc1fd5c0-9342-47e5-9e24-a2f46f04d77b12025-03-04

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 110 of 206 · 4,115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Sense Pain ReliefACETAMINOPHENProficient Rx LPb4cb4a62-9ef7-4185-8770-e9a806c2fb3f2025-08-01WarningsExact identifier
application number: M013
unii: 362O9ITL9D
meijer Nighttime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.377248b6-d64d-8dff-e063-6394a90a43f62025-07-31WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen, IbuprofenACETAMINOPHEN, IBUPROFENGLENMARK THERAPEUTICS INC., USA57a8dc2b-a3bc-49fa-b605-2330155bdbff2025-07-31WarningsExact identifier
unii: 362O9ITL9D
meijer Daytime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEMeijer, Inc.3771f778-7ac9-7108-e063-6394a90a11052025-07-31WarningsExact identifier
unii: 362O9ITL9D
Systane UltraPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.0537c23a-15f7-be64-1231-a6c93468e9a82025-07-30WarningsExact identifier
unii: 6DC9Q167V3
SystanePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.1d679d0f-cec2-a644-79cd-079607254bb92025-07-30WarningsExact identifier
unii: 6DC9Q167V3
Systane Ultra Preservative FreePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.751fb85f-6683-4b0a-a650-324d4a74c5de2025-07-30WarningsExact identifier
unii: 6DC9Q167V3
Pain ReliefACETAMINOPHENAAA Pharmaceutical, Inc.36ad21a3-6229-e91b-e063-6394a90a79332025-07-29WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackfa88d7b2-6c8e-4893-bd81-ecd4f2aca4932025-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Systane COMPLETE PFPROPYLENE GLYCOLAlcon Laboratories, Inc.99b63d62-1cf0-4f28-8760-773917c2538a2025-07-29WarningsExact identifier
unii: 6DC9Q167V3
Childrens AcetaminophenACETAMINOPHENBryant Ranch Prepack190bb2dc-92b4-4b59-a47f-a0251df8261c2025-07-29WarningsExact identifier
application number: M013
rxcui: 307668
unii: 362O9ITL9D
Extra Strength NiteTime Pain ReliefACETAMINOPHEN 500 MG,DIPHENHYDRAMINE HYDROCHLORIDE 25 MG TABLETWALGREENSc25c75c7-157f-1c0d-e053-2995a90a2e3c2025-07-25WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEWalmart Inc.21ab3d58-bb0e-3e51-e063-6294a90ad4152025-07-25WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Childrens TYLENOLACETAMINOPHENKenvue Brands LLC3a935584-6045-0a58-e063-6394a90a40c42025-07-23WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Doctor Butler Hemorrhoid and Fissure Advanced FormulaGLYCERIN 37.5%, LANOLIN 12.5%, LIDOCAINE 4%, ZINC OXIDE 5%Beyond Health, PAd2a769e2-afd0-aed2-e053-2995a90ad4292025-07-23WarningsExact identifier
unii: PDC6A3C0OX
DR. SANA PAIN AND FEVER FOR ChildrenACETAMINOPHENGADAL Laboratories, Inc8a22a5ba-8623-4cca-8723-52b4954034612025-07-23WarningsExact identifier
application number: M013
unii: 362O9ITL9D
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENDirect_Rx90a11364-fc42-e94e-e053-2a95a90a97822025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Defensol DACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCIMenper Distributors, Inc.f466c660-69eb-4581-81ff-1499fa421d8b2025-07-22WarningsExact identifier
unii: 362O9ITL9D
Defensol D Blister PackACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCIMenper Distributors, Inc.0dfcc977-6101-4536-e063-6294a90a7a482025-07-22WarningsExact identifier
unii: 362O9ITL9D
DuralginaACETAMINOPHENMenper Distributors Inc.bb31f66c-80a9-4bdb-983b-cef5d21de5ff2025-07-22WarningsExact identifier
application number: M013
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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