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 4 of 210 · 4,181 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENREMEDYREPACK INC.464e404a-1957-44a2-a53a-f2a9d3c15bde2026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Multi-Symptom AllergyACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLWalgreen Company5170c450-989d-44fa-ab38-86c78feae3b62026-08-28WarningsExact identifier
unii: 362O9ITL9D
REFRESH LIQUIGELCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.4b8b2f6a-4b89-446c-9e5b-9b83c453a01d2026-08-28WarningsExact identifier
unii: K679OBS311
AspirinASPIRINWinCo Foods, LLCa0a19cd1-eb8a-4773-be00-78de90d2a3c32026-08-28WarningsExact identifier
application number: M013
Pain Reliever PM Extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreens54cbbc5f-908b-47b2-b37f-3646354d35682026-08-27WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEREMEDYREPACK INC.40d4a71e-341e-48b3-b925-ba35b7910dff2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
major acetaminophenACETAMINOPHENMajor Pharmaceuticalsca9e1dae-eefb-4653-952f-2fde090596932026-08-27WarningsExact identifier
unii: 362O9ITL9D
daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEAmazon.com Services LLC6de619d3-0ab0-43e7-8dac-7bbd5368ac652026-08-27WarningsExact identifier
unii: 362O9ITL9D
Nighttime Cold and Flu Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCIWalgreens37896933-3ed3-457f-8a32-ee0d784a19e82026-08-27WarningsExact identifier
unii: 362O9ITL9D
equaline dual action pain relieverACETAMINOPHEN, IBUPROFENUnited Natural Foods, Inc. dba UNFIae0dc3f1-ee6f-4347-af5d-70f45dd68bdb2026-08-27WarningsExact identifier
unii: 362O9ITL9D
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Daytime Cold and Flu mini SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corpdfb0fe2e-b0c7-409a-bd1a-fd12485665ba2026-08-26WarningsExact identifier
unii: 362O9ITL9D
Nighttime Severe Cold and Flu Maximum Strength mini softgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLShield Pharmaceuticals Corp70c5517d-be4e-4317-b4f4-df660c71c6992026-08-26WarningsExact identifier
unii: 362O9ITL9D
Childrens Pain and FeverACETAMINOPHENFSA STORE INC.5502ef15-9f40-db56-e063-6394a90a2de42026-08-26WarningsExact identifier
application number: M013
unii: 362O9ITL9D
foster and thrive dual actionACETAMINOPHEN, IBUPROFENStrategic Sourcing Services LLCf970d423-1d92-40c0-8358-91d1f963505c2026-08-26WarningsExact identifier
unii: 362O9ITL9D
DG Health 8 Hour Pain ReliefACETAMINOPHENDolgencorp Incd102e8a2-2fff-48cb-9864-7582fde956ed2026-08-26WarningsExact identifier
unii: 362O9ITL9D
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.c1f9ec75-7eb2-405c-8cdc-097cbf2cf87d2026-08-26WarningsExact identifier
unii: 362O9ITL9D
Pain RelieverACETAMINOPHEN, IBUPROFENCVS Pharmacy9126e680-d5ff-4189-9f9a-d797822ce6702026-08-26WarningsExact identifier
unii: 362O9ITL9D
Leader Dual Action Pain RelieverACETAMINOPHEN, IBUPROFENCardinal Health 110, LLC. dba Leader2bb1f616-48af-4fe1-9aa9-32fcb2dba50c2026-08-26WarningsExact identifier
unii: 362O9ITL9D
Dye Free Pain and Fever ChildrensACETAMINOPHENWalgreens3ea217dd-e5b9-4d4b-861a-76ce61ba3a1d2026-08-26WarningsExact identifier
application number: M013
rxcui: 307668
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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