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 43 of 208 · 4,155 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AspirinASPIRINHyVee Inc3730ee46-b241-44eb-94fa-52b9d12a9c352026-04-08WarningsExact identifier
application number: M013
AspirinASPIRINWalgreen Company82cc404b-fcf5-4e48-ab1a-09d8c47f9e042026-04-08WarningsExact identifier
application number: M013
Menstrual Pain Relief Maximum Strength / Multi SymptomACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATEDOLGENCORP, LLCd441088b-fb1d-4fdc-954f-032f3122212f2026-04-08WarningsExact identifier
unii: 362O9ITL9D
MIGRAINE FORMULAACETAMINOPHEN, ASPIRIN, CAFFEINEMeijer, Inc.529b6ee6-043c-430a-b2e1-b63c81f102912026-04-08WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack092f4694-98df-41bd-b37c-afbcda087e562026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENCardinal Health 107, LLC9efcce86-dd57-4ea2-ad31-d2038eb61bf12026-04-07WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Mucus Relief Sinus Pressure Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED33646fab-79a5-4f10-8ac0-48423eac9b562026-04-07WarningsExact identifier
unii: 362O9ITL9D
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC1b164780-ec84-4187-8afa-6f8a0da550fc2026-04-07WarningsExact identifier
application number: M013
unii: 362O9ITL9D
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC201b860d-dc3c-4380-affa-e757bf2103cf2026-04-07WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Thera Plus HemorrhoidalGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMFourstar Group USA, Inc.5d63bf97-29d2-4c71-97c3-85f425e862072026-04-07WarningsExact identifier
unii: PDC6A3C0OX
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepacka3cbf0c1-b589-4e4a-b355-01bddb7e49552026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackf7b554ab-2996-4cf0-a498-01cd5ef5df4f2026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack5431c1bf-469b-4944-a558-52d098c9b0f02026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepacke5d6de20-c195-4b97-963a-2f3832e50b492026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack6fae7c90-1d80-4eb8-bbb8-8f945884f5c62026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
basic care nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmazon.com Services LLC76e19b9a-3bdb-479a-9503-9e8250109c842026-04-07WarningsExact identifier
unii: 362O9ITL9D
Pain RelieverACETAMINOPHENWalgreens6e7475e2-81a9-43b5-9b81-b58ab761a6f42026-04-07WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack3bd8e7b1-e31c-4298-ba1e-eaf2a09542082026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepacka2e33ea3-941f-4810-b008-abbb109730a92026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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