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 52 of 205 · 4,086 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl LiquidACETAMINOPHEN, DIPHENHYDRAMINE HCLKroger44520aa1-b63f-4239-e063-6394a90a5e142026-02-25WarningsExact identifier
application number: M013
Discount Drug Mart Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMDiscount Drug Mart4ba1b369-54e2-5224-e063-6394a90a47692026-02-25WarningsExact identifier
unii: K679OBS311
Leader Extra Strength Effervescent Antacid and Pain RelieverASPIRIN, CITRIC ACID, SODIUM BICARBONATECardinal Healthc5d7bf5f-3e59-52f2-e053-2a95a90a4a002026-02-25WarningsExact identifier
application number: M013
unii: XF417D3PSL
Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMKC Pharmaceuticals, Inc.4bafa882-50b7-e3e2-e063-6294a90a76e32026-02-25WarningsExact identifier
unii: K679OBS311
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEGenus Lifesciences Inc.95a5d638-3072-4c37-a4cd-f8550328e2c62026-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
leader tussin cfACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECardinal Health 110, LLC. dba Leaderb3e3699b-b36c-453c-8f3b-0001388c8e822026-02-25WarningsExact identifier
unii: 362O9ITL9D
Childrens Pain and FeverACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED12fd643d-7c60-453f-a81f-407ed20e87252026-02-25WarningsExact identifier
application number: M013
rxcui: 307668
unii: 362O9ITL9D
Childrens Pain and FeverACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd96a1531-772b-4a5c-89e4-66fff1fa3d782026-02-25WarningsExact identifier
application number: M013
rxcui: 307668
unii: 362O9ITL9D
Sinus Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company97554f40-f9aa-4dbf-a6f2-de6197236ab42026-02-25WarningsExact identifier
unii: 362O9ITL9D
Gentle Care KitZINC OXIDEKenvue Brands LLC4b8f7a5a-2fc4-ea00-e063-6294a90ab95b2026-02-24WarningsExact identifier
application number: M013
rxcui: 307668
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBest Choice (Valu Merchandisers Company)64a93715-e7b1-4de1-8099-8ad6c585d5172026-02-24WarningsExact identifier
unii: 362O9ITL9D
Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATEHaleon US Holdings LLC444fa225-c204-45d1-b3b3-aa5650ee5d072026-02-23WarningsExact identifier
application number: M013
Excedrin Extra Strength and Excedrin Tension HeadacheACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINEHaleon US Holdings LLC2c8df1c7-7864-48df-939c-d9ae22e0f52c2026-02-23WarningsExact identifier
application number: M013
Equate Childrens Pain and FeverACETAMINOPHENWal-Mart Stores Inc40eedfe9-54e1-40a2-b4a2-55ff708b89cd2026-02-23WarningsExact identifier
application number: M013
rxcui: 307668
unii: 362O9ITL9D
hydrocodone bitartrate and acetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENStrides Pharma Science Limitedcc7f0a16-ff27-44d0-b69a-3f6aea1b993b2026-02-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Excedrin Rapid ReliefACETAMINOPHENHaleon US Holdings LLC3a36b7ca-396e-cfd8-e063-6294a90a76ab2026-02-22WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Head Congestion and Flu Severe ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation416080a9-e817-485b-a4ae-6c9d0152c1652026-02-20WarningsExact identifier
unii: 362O9ITL9D
Mitochondria ProARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.2f365207-b730-428d-9465-8853e86e79ff2026-02-18WarningsExact identifier
unii: XF417D3PSL
good sense night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEL. Perrigo Companye47dffdf-5778-4804-8ce2-54c5a72bba3a2026-02-18WarningsExact identifier
unii: 362O9ITL9D
NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED3fb49f64-2d77-44db-8186-5904837eedbe2026-02-17WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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