FDA.reportPublic FDA data

NDC 68094-231-01 - 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
68094-231
Requested NDC
68094-231-01
Package NDCs from labels
68094-231-59, 68094-231-62, 68094-231-61, 68094-231-01, 68094-231-58
Manufacturer
Precision Dose, Inc. | L Perrigo Company
Effective date
2025-08-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Acetaminophen - Precision Dose, Inc. | L Perrigo CompanyPrecision Dose, Inc. | L Perrigo Company2025-08-29HUMAN OTC DRUG LABEL
ACETAMINOPHEN ORAL SUSPENSIONPrecision Dose, Inc.2025-02-19HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68094-231-01Acetaminophen5 mL in 1 SYRINGE, PLASTICSUSPENSION514
68094-231-58Acetaminophen5 in 1 CASESUSPENSION514
68094-231-58Acetaminophen10 in 1 BAGSUSPENSION1014
68094-231-59Acetaminophen5 mL in 1 CUP, UNIT-DOSESUSPENSION514
68094-231-61Acetaminophen10 in 1 TRAYSUSPENSION1014
68094-231-61Acetaminophen10 in 1 CASESUSPENSION1014
68094-231-62Acetaminophen3 in 1 CASESUSPENSION314
68094-231-62Acetaminophen10 in 1 TRAYSUSPENSION1014
68094-231-01Acetaminophen5 mL in 1 SYRINGE, PLASTICSUSPENSION59
68094-231-58Acetaminophen5 in 1 CASESUSPENSION59
68094-231-58Acetaminophen10 in 1 BAGSUSPENSION109
68094-231-59Acetaminophen5 mL in 1 CUP, UNIT-DOSESUSPENSION59
68094-231-61Acetaminophen10 in 1 CASESUSPENSION109
68094-231-61Acetaminophen10 in 1 TRAYSUSPENSION109
68094-231-62Acetaminophen10 in 1 TRAYSUSPENSION109
68094-231-62Acetaminophen3 in 1 CASESUSPENSION39

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-231ACETAMINOPHEN SUSPENSION [PRECISION DOSE, INC.]9Current NDC, Legacy NDC, 8 package rows20250302_554a7381-7f9a-4782-916a-10f9bc44b4f6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-231-01ML - Milliliter68094-231ca2729f0-1654-4056-ba4e-d8839953404512023-09-05
68094-231-58ML - Milliliter68094-231b166d608-0ecd-4dcc-abc9-12da5b15afd812023-09-05
68094-231-59ML - Milliliter68094-231665e7ac6-6256-400a-b2b4-7b36c5c09bda12020-07-13
68094-231-61ML - Milliliter68094-2310ebd0555-09cf-4fcc-b914-4611479c91a912020-04-20
68094-231-62ML - Milliliter68094-23105d125e2-1db3-4d22-9c11-68b5f59bb65912020-04-20

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 75 of 208 · 4,155 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen and Ibuprofen (NSAID)ACETAMINOPHEN AND IBUPROFEN (NSAID)RETAIL BUSINESS SERVICES,LLCe7b7009a-89a4-720d-e053-2a95a90abff72025-12-19WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENRETAIL BUSINESS SERVICES,LLC.a56791ec-0037-51a3-e053-2995a90af7612025-12-19WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENRAONBIO CORPf6f5251d-db89-4b69-e053-6394a90a10282025-12-19WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENWALGREENS8f8d43d1-8e73-483e-e053-2a95a90ac99b2025-12-19WarningsExact identifier
unii: 362O9ITL9D
DayTime Cold/Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICE04f9134e-1311-4843-90db-9244b9e61e1d2025-12-19WarningsExact identifier
unii: 362O9ITL9D
Nighttime Cold/Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEARMY AND AIR FORCE EXCHANGE SERVICE029e6215-b72d-4fd0-8918-db1abcc4490a2025-12-19WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENPUBLIX SUPERMARKETS, INC08f57305-0c4b-96b1-e063-6394a90a77df2025-12-19WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENLEADER/ Cardinal Health 110, Inc.f1d69088-4d52-cbb5-e053-2995a90a3ec82025-12-19WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENWALGREENS CO.8dba6ae0-1bfb-84de-e053-2a95a90aae462025-12-19WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen and Diphenhydramine HCLACETAMINOPHEN AND DIPHENHYDRAMINE HCLPUBLIX SUPERMARKETS, INC08f549cf-042a-7bf2-e063-6394a90a83ef2025-12-19WarningsExact identifier
application number: M013
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENLEADER/ Cardinal Health 110, Incf797848e-f23f-997b-e053-6394a90aae552025-12-19WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENMAJOR PHARMACEUTICALSefd0a432-abbb-1f88-e053-2995a90a8ce52025-12-19WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENWALGREEN CO.b8a855ae-c0a3-0b05-e053-2a95a90ac8a82025-12-19WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENRUGBY LABORATORIESed340993-04e6-b084-e053-2a95a90abf602025-12-19WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENLEADER/ Cardinal Health 110, Incf5dc335d-d3cf-ba94-e053-2a95a90ac6d32025-12-19WarningsExact identifier
unii: 362O9ITL9D
Childrens Pain and FeverACETAMINOPHENMarc Glassman, Inc.f708e1ec-cf2a-4e2b-851f-f6b703f359b22025-12-19WarningsExact identifier
application number: M013
rxcui: 307668
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENWALGREEN CO.b375de90-25c7-aa55-e053-2995a90a3cf82025-12-19WarningsExact identifier
application number: M013
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENTARGET CORPORATIONe64a3c32-5466-0662-e053-2a95a90ae9632025-12-19WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Acetaminophen Diphenhydramine HCLACETAMINOPHEN DIPHENHYDRAMINE HCLWALGREENS CO.d92d97a8-0ee3-1206-e053-2a95a90a72a82025-12-19WarningsExact identifier
application number: M013
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENSAM'S WEST INC0c8e7095-0806-4501-e063-6394a90a89aa2025-12-19WarningsExact identifier
application number: M013
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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