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 42 of 208 · 4,155 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good sense night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEL. Perrigo Company0c79357a-b79d-4952-8e6d-ef3d60dde2fa2026-04-10WarningsExact identifier
unii: 362O9ITL9D
basic care nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLC88d27c25-a305-4398-9590-df10d2504b012026-04-09WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack8e99994a-83b4-4b1f-9654-4ae373bf2c4d2026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Leader Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECardinal Health 110, LLC. dba Leadere7ad8d2d-01fd-40d9-a972-b2ca14cc97fb2026-04-09WarningsExact identifier
unii: 362O9ITL9D
Sinus and Headache DaytimeACETAMINOPHEN, PHENYLEPHRINE HCLL.N.K. International, Inc.e20b1093-d77f-4c39-b105-adaa1b82ea762026-04-09WarningsExact identifier
unii: 362O9ITL9D
WE FRESH Lubricating Eye DropsGLYCERINOculus Surgical, Inc.4f253b5d-001b-091e-e063-6394a90a9d392026-04-09WarningsExact identifier
unii: PDC6A3C0OX
Oxycodone Hydrochloride and AcetaminophenOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENElite Laboratories, Inc.27fa8190-d334-4bb9-b277-d1f44db433e32026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATELidl US LLCb26ac105-f8e4-4ad0-8a26-9fdf30c017002026-04-09WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack5a7fb0e7-eb06-4332-a786-d0051afd1dd92026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Care One migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINEAmerican Sales Companybe6c9dc5-853e-4342-ba6a-e5b7be5afe722026-04-09WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack679b4f87-59df-48d4-a9e6-e78aaeab23ea2026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackd3b7f2b3-28c4-4ba5-961f-48e838600be22026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Sinus Pressure and Pain Maximum StrengthACETAMINOPHEN, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader80d25e23-b108-4eb1-88c7-73fe9da8f9422026-04-09WarningsExact identifier
unii: 362O9ITL9D
Sore ThroatPHENOL GLYCERINWalgreens1e845299-178e-49ce-9d08-7e9d548a5a6d2026-04-09WarningsExact identifier
unii: PDC6A3C0OX
Pain Reliever ChildrensACETAMINOPHENH E B7e43de11-d20b-4920-a04d-3c1b5d35e0052026-04-09WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Tylenol Cold Plus Flu Plus Chest CongestionACETAMINOPHEN, GUAIFENESINKenvue Brands LLC4e60e1ad-4ad4-c329-e063-6294a90ab3182026-04-08WarningsExact identifier
unii: 362O9ITL9D
Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINENavajo Manufacturing Company Inc.f7e572e9-82a7-2127-e053-6394a90ab01a2026-04-08WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Bayer Genuine AspirinASPIRINNavajo Manufacturing Company Inc.f6f2ce71-5728-aefb-e053-6394a90a20e42026-04-08WarningsExact identifier
application number: M013
MidolACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATENavajo Manufacturing Company Inc.cabd10f2-a91e-4406-9249-915e306c867b2026-04-08WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Excedrin MigraineACETAMINOPHEN, ASPIRIN, AND CAFFEINENavajo Manufacturing Company Inc.4efbd21b-92fe-96a7-e063-6294a90ac4ad2026-04-08WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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