FDA.reportPublic FDA data

NDC 82568-0010-08 - CHILDRENS 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
82568-0010
Requested NDC
82568-0010-08
Package NDCs from labels
82568-0010-2, 82568-0010-4, 82568-0010-8, 82568-0010-6, 82568-0010-08
Manufacturer
AARNA USA INC.
Effective date
2025-06-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CHILDRENS ACETAMINOPHEN - AARNA USA INC.AARNA USA INC.2025-06-20HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82568-0010-2CHILDRENS ACETAMINOPHEN60 mL in 1 BOTTLESUSPENSION601
82568-0010-4CHILDRENS ACETAMINOPHEN118 mL in 1 BOTTLESUSPENSION1181
82568-0010-6CHILDRENS ACETAMINOPHEN473 mL in 1 BOTTLESUSPENSION4731
82568-0010-8CHILDRENS ACETAMINOPHEN236 mL in 1 BOTTLESUSPENSION2361

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 56 of 205 · 4,086 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain RelieverACETAMINOPHENRite Aid Corporation9a647967-f0c6-466e-be70-34fd3de0a8032026-02-02WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Tussin SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINHyVee Inc85252999-3463-45fe-b4a9-7a97960b41b12026-02-02WarningsExact identifier
unii: 362O9ITL9D
Pain Reliever Extra StrengthACETAMINOPHENWal-Mart Stores Inc72365264-f9c4-49f0-be64-73d95817d3582026-02-02WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Acetaminophen 325mgACETAMINOPHENMarlex Pharmaceuticals Inc4a18168c-dd36-8280-e063-6394a90a7e102026-02-01WarningsExact identifier
application number: M013
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENMarlex Pharmaceuticals Inc4a183b7d-3a1e-5557-e063-6294a90a54932026-02-01WarningsExact identifier
application number: M013
unii: 362O9ITL9D
cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHyVee Inc5110526f-51fd-401e-ba52-520674d34f372026-02-01WarningsExact identifier
unii: 362O9ITL9D
OptaseGLYCERINScope Health Inc376e0289-28e9-e87f-e063-6294a90a3b042026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Inc10c3e31d-779d-8ff6-e063-6294a90acd392026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Inc9e96976b-2990-79e0-e053-2995a90a0f292026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Incd81c1a4f-87b0-ee8c-e053-2995a90af9e52026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Incf452a2c4-c869-7bf5-e053-2995a90ac1a02026-01-30WarningsExact identifier
unii: PDC6A3C0OX
Migraine ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEFamily Dollar (FAMILY WELLNESS)bfcffa70-94a9-43de-9f22-4ed6a71c0a8d2026-01-29WarningsExact identifier
unii: 362O9ITL9D
Regener-Eyes Ophthalmic Solution LITE XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.47ab9609-4291-30b2-e063-6394a90a421e2026-01-29WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution PROFESSIONAL STRENGTH XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.48d6dc98-66e8-b499-e063-6394a90ae9352026-01-29WarningsExact identifier
unii: PDC6A3C0OX
EXTRA STRENGTH PAIN RELEIFACETAMINOPHENStrategic Sourcing Services, LLC0392db17-c4f3-424b-9dee-549fc5df61c52026-01-29WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Regular Strength Pain RelieverACETAMINOPHENStrategic Sourcing Services, LLC959db1b0-2d9f-4857-b475-0fa0273652122026-01-29WarningsExact identifier
application number: M013
unii: 362O9ITL9D
ASPIRINASPIRINStrategic Sourcing Services LLC8acdbcf9-64a0-4dda-b60e-7e122254ecf32026-01-29WarningsExact identifier
application number: M013
OptaseGLYCERINScope Health Inc86c14327-ffc7-806e-e053-2991aa0aaf922026-01-29WarningsExact identifier
unii: PDC6A3C0OX
Night Time Cold and Flu ReadyInCaseACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEP & L Development, LLCe7dd763b-3005-4723-933b-171eb772afee2026-01-29WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen Extra StrengthACETAMINOPHENFOODHOLD U.S.A., LLCbc19bd47-69ea-4bcc-8d28-c043c9d325132026-01-29WarningsExact identifier
application number: M013
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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