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 40 of 206 · 4,102 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HCLDOLGENCORP, LLC8e65478b-7a7b-416c-b8e3-23dad79f8cc12026-04-16WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLValu Merchandisers Companycdcb8e0d-7847-4f28-bb09-7dc7b5d35c132026-04-16WarningsExact identifier
unii: 362O9ITL9D
Aspirin Low DoseASPIRINValu Merchandisers Companyc9e384e5-fa9b-4c75-b5e3-16eb8db662ef2026-04-16WarningsExact identifier
application number: M013
Cold Multi-Symptom SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLValu Merchandisers Companyb0d9d869-9f0d-4834-aa2b-1ee21fd8b67b2026-04-16WarningsExact identifier
unii: 362O9ITL9D
Rompe Pecho MaxACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESINEfficient Laboratories Inc4f86985c-48f3-2148-e063-6394a90ae2f12026-04-15WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENPreferrred Pharmaceuticals Inc.cb92ebea-86be-4bdf-a608-50be8be770fb2026-04-15WarningsExact identifier
unii: 362O9ITL9D
EXTRA STRENGTH PAIN RELIEFACETAMINOPHENPreferred Pharmaceuticals Inc.e18294f5-8fd5-4ac6-802c-f6d257e8bee72026-04-15WarningsExact identifier
unii: 362O9ITL9D
CLENPIQSODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.e95fff66-4ec0-4001-a727-33e66a5ec7d52026-04-15Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
AcetaminophenACETAMINOPHENPreferred Pharmaceuticals Inc.b6abfbbb-9826-4cd6-940f-3a314480a5a52026-04-15WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Good Sense Pain ReliefACETAMINOPHENPreferred Pharmaceuticals Inc.36708cac-c076-4514-bfa1-9db6918749002026-04-15WarningsExact identifier
unii: 362O9ITL9D
Sinus and HeadacheACETAMINOPHEN, PHENYLEPHRINE HCLWalgreen Company2115f095-2d75-4e02-a6af-22dd693e08402026-04-14WarningsExact identifier
unii: 362O9ITL9D
daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED5515148f-3e1d-4b03-89fa-40967d5082922026-04-14WarningsExact identifier
unii: 362O9ITL9D
Good Sense Pain and FeverACETAMINOPHENL. Perrigo Companyf7137fe6-582e-43a4-8302-90ca54cd1de32026-04-14WarningsExact identifier
application number: M013
rxcui: 307668
unii: 362O9ITL9D
Mucus Relief Sinus Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDc70e6506-6c5b-4d3f-ab18-a690840caabc2026-04-13WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENCardinal Health 107, LLCe13656eb-513e-411e-bdae-35ff1ba7cfc12026-04-13WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Artificial Tears Lubricant Eye DropsGLYCERIN, PROPYLENE GLYCOLCVS Pharmacy28297fee-8185-4869-8f39-5bfbf8bf8bfd2026-04-13WarningsExact identifier
unii: PDC6A3C0OX
blink boostGLYCERINBausch & Lomb Incorporatede765c224-1718-488f-99b2-976eb60c1d632026-04-13WarningsExact identifier
unii: PDC6A3C0OX
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack3339d3bd-b416-4c5b-8984-0c376544d8a92026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Severe Sinus CongestionACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company8745d9d8-640d-4e3b-96fe-d25032c1e3ce2026-04-13WarningsExact identifier
unii: 362O9ITL9D
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEAmici Pharma, Inc.fb12459c-82f8-43d2-8c05-a4b6d4a3e9482026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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