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 58 of 208 · 4,155 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Regener-Eyes Ophthalmic Solution PROFESSIONALGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC49771efa-6682-51d0-e063-6294a90a18a52026-01-28WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution LITEGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC497763ee-dc70-bb48-e063-6294a90afb3d2026-01-28WarningsExact identifier
unii: PDC6A3C0OX
Extra Strength AcetaminophenACETAMINOPHENPreferred Pharmaceuticals Inc.b25faa8c-2d13-450a-970f-81c17a6330302026-01-28WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Daytime Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBRFamily Dollar (FAMILY WELLNESS)fe3e74ba-31d9-4d50-ab61-ffb6aaa660852026-01-28WarningsExact identifier
unii: 362O9ITL9D
Leader Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECardinal Health 110, LLC. dba Leader9b1a5dbe-39dd-4dbb-800c-0cef422ae7c52026-01-28WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company93d5b1db-e9ad-4a6a-b869-fd0d1a11df022026-01-27WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED37e8ccd5-6be1-9aca-e063-6394a90a52632026-01-27WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine SuccinateACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATESOFTGEL HEALTHCARE PRIVATE LIMITED2f7f078e-de04-9d53-e063-6394a90a409f2026-01-27WarningsExact identifier
unii: 362O9ITL9D
Carboxymethylcellulose Sodium Eye Drops 0.5%CARBOXYMETHYLCELLULOSE SODIUM EYE DROPS 0.5%Aurolabe8b4df3b-3d81-b3ca-e053-2a95a90af2ec2026-01-27WarningsExact identifier
unii: K679OBS311
AURO-CMCCARBOXYMETHYLCELLULOSE EYE DROPS 0.5%Aurolabe90b397f-fe64-8674-e053-2995a90a223f2026-01-27WarningsExact identifier
unii: K679OBS311
EXTRA STRENGTH ACETAMINOPHENACETAMINOPHENWal-Mart Stores Inca88eba4c-0701-4eec-9a24-a804186fbfd82026-01-27WarningsExact identifier
application number: M013
unii: 362O9ITL9D
EXTRA STRENGTH PAIN RELIEVER PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEWALMART INC.649e0dd8-ca79-4bf1-9c15-9db9f1d2f5bd2026-01-27WarningsExact identifier
application number: M013
unii: 362O9ITL9D
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC4961695d-72f3-533a-e063-6294a90a5a292026-01-27WarningsExact identifier
application number: M013
unii: 362O9ITL9D
XL-3 Night TimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATERnv LLC03210929-331e-462d-b566-4e1865f522462026-01-27WarningsExact identifier
unii: 362O9ITL9D
XL-3 Day TimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLRnv LLC2381ff41-4584-4b38-839f-f94e733f5bf22026-01-27WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHENACETAMINOPHENNuCare Pharmaceuticals, Inc.4965fc33-f815-d49e-e063-6394a90a119c2026-01-27WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Cold and Flu Daytime SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution Inc5ca7dc60-af0c-47c6-b453-8b39c744eb5b2026-01-27WarningsExact identifier
unii: 362O9ITL9D
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHyVee Inc2ce5f2af-cabc-466f-b0c5-256e6e6d4c882026-01-27WarningsExact identifier
unii: 362O9ITL9D
Sinus Headache and Pain Day, Non-drowsyACETAMINOPHEN, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEc33340c0-47d3-45e2-997b-3d9fb148900f2026-01-27WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu Daytime SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLL.N.K. International, Inc.b7501b59-d25a-49ec-9cbf-47018bce83972026-01-27WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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