NDC 82568-0010-06 - 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: 82568-0010-06
Package NDCs from labels: 82568-0010-2, 82568-0010-4, 82568-0010-8, 82568-0010-6, 82568-0010-06
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
Label	Manufacturer	Effective date	Type
CHILDRENS ACETAMINOPHEN - AARNA USA INC.	AARNA USA INC.	2025-06-20	HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
82568-0010-2	CHILDRENS ACETAMINOPHEN	60 mL in 1 BOTTLE	SUSPENSION	60	1
82568-0010-4	CHILDRENS ACETAMINOPHEN	118 mL in 1 BOTTLE	SUSPENSION	118	1
82568-0010-6	CHILDRENS ACETAMINOPHEN	473 mL in 1 BOTTLE	SUSPENSION	473	1
82568-0010-8	CHILDRENS ACETAMINOPHEN	236 mL in 1 BOTTLE	SUSPENSION	236	1

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 3 of 207 · 4,125 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Maximum Strength Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	KROGER COMPANY	e1d27123-358f-4b0c-8e3b-33474750a0e6	2026-09-02	Warnings	Exact identifier unii: 362O9ITL9D
Kroger Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Kroger Company	c5ce0901-a5d7-46c4-8492-5a80c76e8517	2026-09-02	Warnings	Exact identifier unii: 362O9ITL9D
Maximum Strength Nighttime Cold and Flu	ACETAMINOPHEN , DIPHENHYDRAMINE HCL,PHENYLEPHRINE HCL	THE KROGER CO	058b2021-8a61-40b0-8a2e-a784d2b847fb	2026-09-02	Warnings	Exact identifier unii: 362O9ITL9D
Daytime Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCL	The Kroger Co.	494e69ef-dc9f-4e14-b856-5eaf0f541a03	2026-09-02	Warnings	Exact identifier unii: 362O9ITL9D
Adult Low Dose Chewable Aspirin	ASPIRIN	Farmacias De Similares TX LLC	513ea306-74c6-96e3-e063-6394a90a8262	2026-09-01	Warnings	Exact identifier application number: M013
Kroger Children Pain plus Fever chewables	ACETAMINOPHEN	KROGER COMPANY	83b5733c-70a1-4383-9729-2eb896d0149a	2026-09-01	Warnings	Exact identifier application number: M013 unii: 362O9ITL9D
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	TOP CARE (Topco Associates LLC)	923b443d-73cc-4c52-92e4-a075786b1ae3	2026-09-01	Warnings	Exact identifier application number: M013 unii: 362O9ITL9D
ACETAMINOPHEN PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Amazon.com Services LLC	99a137d6-07eb-43bc-b4b4-1a23041d595e	2026-08-31	Warnings	Exact identifier application number: M013 unii: 362O9ITL9D
Acetaminophen Extra Strength	ACETAMINOPHEN	CVS PHARMACY	64a1ebe7-af28-4b09-96e8-28fa4dcc52bd	2026-08-31	Warnings	Exact identifier application number: M013 unii: 362O9ITL9D
Daytime Cold and Flu Multi Symptom Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Shield Pharmaceuticals Corp	e85b4c2a-d4e0-452c-9a08-fcc0ff6eaa21	2026-08-31	Warnings	Exact identifier unii: 362O9ITL9D
MAX relief junior Grape	CHILDRENS ACETAMINOPHEN	Akron Pharma Inc.	cc769c26-556a-4831-bd75-61a7383aa707	2026-08-31	Warnings	Exact identifier application number: M013 rxcui: 307668 unii: 362O9ITL9D
MAX relief junior	CHILDRENS ACETAMINOPHEN	Akron Pharma Inc.	ebb3b4ba-2d0b-48d9-b6ee-6d4696aea047	2026-08-31	Warnings	Exact identifier application number: M013 rxcui: 307668 unii: 362O9ITL9D
Daytime Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Shield Pharmaceuticals Corp	67849e09-2056-4013-98b1-d003ed3250a2	2026-08-31	Warnings	Exact identifier unii: 362O9ITL9D
MAX relief junior	ACETAMINOPHEN	Akron Pharma Inc.	0e43b885-3843-4f11-9a53-02a38c228313	2026-08-31	Warnings	Exact identifier application number: M013 rxcui: 307668 unii: 362O9ITL9D
MAX relief junior	CHILDREN ACETAMINOPHEN	Akron Pharma Inc.	d7874e4d-0b38-4bb1-9a62-aa4f66d9baf9	2026-08-31	Warnings	Exact identifier application number: M013 rxcui: 307668 unii: 362O9ITL9D
MAX relief junior Grape	CHILDREN ACETAMINOPHEN	Akron Pharma Inc.	3c7a7f40-4963-4fd1-942e-93fa08a45830	2026-08-31	Warnings	Exact identifier application number: M013 rxcui: 307668 unii: 362O9ITL9D
Genexa Kids Pain and Fever	ACETAMINOPHEN	Genexa Inc.	5a615118-33c9-1520-e063-6394a90a21a6	2026-08-31	Warnings	Exact identifier application number: M013 rxcui: 307668 unii: 362O9ITL9D
Acetaminophen PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	United Natural Foods, Inc. dba UNFI	24173e77-92ec-4a87-a471-d6867837c180	2026-08-31	Warnings	Exact identifier unii: 362O9ITL9D
acetaminophen extra strength	ACETAMINOPHEN	Sam's West Inc	dd99efd0-4ca4-4dc6-a940-bebd17ac8f8d	2026-08-28	Warnings	Exact identifier application number: M013 unii: 362O9ITL9D
Aspirin 81 mg	ASPIRIN	HAWAII REPACK, INC.	ac94cce3-9a39-41de-bb8b-10a5e5b8e83b	2026-08-28	Warnings	Exact identifier application number: M013

Reported adverse events (FAERS/openFDA)#

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