Childrens Pain and Fever

Product NDC: 58602-167
11-digit product format: 586020167
Labeler code: 58602
Product ID: 58602-167_f818996c-36d2-4d3d-af3e-39949157edb9
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: SUSPENSION
Route: ORAL
Labeler: Aurohealth LLC
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-07-27
Substance: ACETAMINOPHEN
Active strength: 160 mg/5mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Childrens Pain and Fever
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	160 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
307668	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f818996c-36d2-4d3d-af3e-39949157edb9	Available on FDA.report

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 12 of 83 · 1,657 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Family Dollar (FAMILY WELLNESS)	7a98d4d9-54e2-45c1-a76a-7f1907566e95	2026-06-01	Warnings	Exact identifier application number: M013
Extra Strength Acetaminophen	ACETAMINOPHEN	TIME CAP LABORATORIES, INC.	58840cf4-aceb-c7cf-e063-6294a90a5ff4	2026-06-01	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	CVS Pharmacy	832acd72-1dda-4490-978f-5f31748942df	2026-06-01	Warnings	Exact identifier application number: M013
Acetaminophen PM	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Major Pharmaceuticals	786dbcd5-f5c2-4491-e053-2991aa0a3437	2026-05-29	Warnings	Exact identifier application number: M013
Back and Body Extra Strength	ASPIRIN, CAFFEINE	Meijer Distribution Inc	e513f2d9-d591-4790-a117-6176ce2279dc	2026-05-29	Warnings	Exact identifier application number: M013
Chewable Acetaminophen Childrens	ACETAMINOPHEN	Cardinal Health 110, LLC. DBA Leader	5460a4b7-5da3-4fc2-a565-0b0dd11bbf44	2026-05-29	Warnings	Exact identifier application number: M013
Extra Strength Mini Softgels Pain Reliever	ACETAMINOPHEN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	f55d3663-7007-41cd-ae2d-5aca6311be81	2026-05-28	Warnings	Exact identifier application number: M013
Genexa Kids Pain and Fever	ACETAMINOPHEN	Genexa Inc.	5130c695-a80e-2dd3-e063-6294a90a404f	2026-05-28	Warnings	Exact identifier application number: M013
TYLENOL Regular Strength	ACETAMINOPHEN	Kenvue Brands LLC	1622f694-4d63-4c56-8737-fae31f0ecfb7	2026-05-27	Warnings	Exact identifier application number: M013
INFANTS Pain and Fever	ACETAMINOPHEN	Aurohealth LLC	257436e1-e0f3-4a87-bffe-4f176b836caf	2026-05-27	Warnings	Exact identifier application number: M013
Infants Pain and Fever	ACETAMINOPHEN	Aurohealth LLC	6509a545-0036-460a-8f0d-b31caae17855	2026-05-27	Warnings	Exact identifier application number: M013
Alka-Seltzer Original	ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE	Select Consumer Group	3ca80d74-1e8b-49d9-e063-6394a90a4312	2026-05-24	Warnings	Exact identifier application number: M013
Pain and Fever Chewables Childrens	ACETAMINOPHEN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	bad8ac0a-518d-4639-9b92-a39e0d437238	2026-05-22	Warnings	Exact identifier application number: M013
ACETAMINOPHEN 500 MG	ACETAMINOPHEN	A-S Medication Solutions	92559d65-f5e2-4054-9763-b9c560452dab	2026-05-22	Warnings	Exact identifier application number: M013
Acetaminophen PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	Grocery Outlet, Inc.	441d2629-3fff-0bf1-e063-6394a90aa9b6	2026-05-21	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Grocery Outlet, Inc.	441d1bde-d677-fab7-e063-6394a90aaad4	2026-05-21	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Grocery Outlet, Inc.	441d3a39-cc55-3c7c-e063-6394a90ad7a7	2026-05-21	Warnings	Exact identifier application number: M013
INFANTS Pain and Fever	ACETAMINOPHEN	Aurohealth LLC	b3f57af5-661f-4534-9eed-76e431f338db	2026-05-20	Warnings	Exact identifier application number: M013
Good Sense aspirin	ASPIRIN	L. Perrigo Company	e150dd59-8db8-449f-9c9a-1aa6deb3be2e	2026-05-20	Warnings	Exact identifier application number: M013
Infants Pain and Fever	ACETAMINOPHEN	Aurohealth LLC	e837538d-0515-4f99-b04c-fda63b28777e	2026-05-20	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
58602-167-20	58602016720	1 BOTTLE in 1 CARTON (58602-167-20) / 236 mL in 1 BOTTLE	1 bottle	2026-07-27	No	No	Current
58602-167-24	58602016724	1 BOTTLE in 1 CARTON (58602-167-24) / 118 mL in 1 BOTTLE	1 bottle	2026-07-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Childrens Pain and Fever - Aurohealth LLC \| APL HEALTHCARE LIMITED	Aurohealth LLC \| APL HEALTHCARE LIMITED	2026-07-28	Human OTC Drug Label	1