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 77 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sanatos Multi Symptom Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI	Pharmadel LLC	0ab11691-5b29-55fc-e063-6394a90aa328	2023-11-17	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	A-S Medication Solutions	1e223faa-f6d0-4235-bc4c-6cfca84a5b0a	2023-11-17	Warnings	Exact identifier application number: M013
SanaTos X	ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCI	Pharmadel LLC	85b8ef3d-7318-7f3b-e053-2991aa0a0777	2023-11-14	Warnings	Exact identifier application number: M013
RIGHT REMEDIES EXTRA STRENGTH PM Pain Relief	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	8badbaad-eb35-4251-a779-00474819360d	2023-11-13	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Trifecta Pharmaceuticals USA LLC	09935a74-34b0-0e7c-e063-6294a90a7c83	2023-11-07	Warnings	Exact identifier application number: M013
Pain Relief PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	AMERIFOODS TRADING COMPANY	f6dd6396-93e9-1096-e053-6394a90af06d	2023-11-02	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	RETAIL BUSINESS SERVICES , LLC.	eb644e9e-36dc-5f84-e053-2a95a90affa5	2023-11-02	Warnings	Exact identifier application number: M013
Good Sense Childrens Pain and Fever	ACETAMINOPHEN	Proficient Rx LP	46527b1f-7515-44ce-b5cb-9d24223b9af1	2023-11-01	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	A-S Medication Solutions	12feb32b-4b8c-4b17-9e86-cb286457b088	2023-11-01	Warnings	Exact identifier application number: M013
Acetaminophen, Aspirin, Caffeine	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Proficient Rx LP	af8b30a0-7a56-4557-8404-cc8059fcd6bc	2023-11-01	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	AMERIFOODS TRADING COMPANY	f6dd387d-c768-9443-e053-6394a90aca14	2023-10-31	Warnings	Exact identifier application number: M013
ASPIRIN	ASPIRIN	AMERIFOODS TRADING COMPANY	f6cec280-17a5-5c5d-e053-6394a90a81aa	2023-10-31	Warnings	Exact identifier application number: M013
Regular Strength Aspirin	ASPIRIN	CARDINAL HEALTH, INC.	8aaa82c6-b46b-25c5-e053-2a95a90a3793	2023-10-30	Warnings	Exact identifier application number: M013
SafeTynadol	ACETAMINOPHEN	Sinew Pharma Inc.	b956d527-7ea7-e084-e053-2a95a90a866d	2023-10-28	Warnings	Exact identifier application number: M013
Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Magno-Humphries, Inc.	9d2275c8-0c3d-d2b3-e053-2995a90a368e	2023-10-27	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	Magno-Humphries, Inc.	9d22bedb-9fb3-8421-e053-2a95a90acf4a	2023-10-27	Warnings	Exact identifier application number: M013
Acetaminophen Regular Strength	ACETAMINOPHEN	Magno-Humphries, Inc.	9d22d642-8aaf-d17e-e053-2995a90ae182	2023-10-27	Warnings	Exact identifier application number: M013
ENTERIC COATED ASPIRIN	ASPIRIN	Magno-Humphries, Inc.	a7c02378-4213-4e57-aca2-2437ad02f786	2023-10-27	Warnings	Exact identifier application number: M013
Extraprin	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Magno-Humphries, Inc.	9d22cdc8-29c5-4273-e053-2a95a90ad0bf	2023-10-27	Warnings	Exact identifier application number: M013
Regular Strength Enteric coated aspirin	ASPIRIN	Geri-Care Pharmaceutical Corp	c321208c-f192-42c5-9454-e0df5d02d685	2023-10-26	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