Home NDC 58602-167 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.
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 27 of 83 · 1,657 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aspirin Pain reliver ASPIRIN Pioneer Life Sciences, LLC 8dc29957-2ac1-47f8-89fd-a6bcf97ee3d3 2025-12-23 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Granules USA, Inc a1255f60-b9c6-9a95-e053-2995a90a9e80 2025-12-22 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Granules USA, Inc a51395ea-e038-dc9c-e053-2a95a90a287d 2025-12-22 Warnings Exact identifier application number: M013 CareALL Acetaminophen ACETAMINOPHEN New World Imports, Inc 1148b4d9-fa6a-49e6-9663-17b2c8373846 2025-12-22 Warnings Exact identifier application number: M013 CAREALL Aspirin ASPIRIN New World Imports, Inc f4aa0de9-ffcc-4140-91a3-fd9e7a55f2ac 2025-12-22 Warnings Exact identifier application number: M013 Vitapirena ACETAMINOPHEN Pharmadel LLC 0547bc1f-d000-f5a6-e063-6294a90ac73d 2025-12-22 Warnings Exact identifier application number: M013 CareALL Acetaminophen Extra Strength ACETAMINOPHEN New World Imports, Inc f818417e-0b31-4fe7-8313-4160a00b248a 2025-12-22 Warnings Exact identifier application number: M013 CareALL Acetaminophen ACETAMINOPHEN New World Imports, Inc c4f82ed8-b82c-47bb-9ab9-108a13d29cf7 2025-12-22 Warnings Exact identifier application number: M013 CareALL Acetaminophen Extra Strength ACETAMINOPHEN New World Imports, Inc 5103450a-3095-49cc-9823-4fb4c1d258ff 2025-12-22 Warnings Exact identifier application number: M013 CAREALL Non-Aspirin PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL New World Imports, Inc 499b2bf8-72fb-4500-b16e-517cab09a8ae 2025-12-22 Warnings Exact identifier application number: M013 CAREALL Pain Relief PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL New World Imports, Inc 933154b9-c9d6-4260-8775-1c83631c74e4 2025-12-22 Warnings Exact identifier application number: M013 CAREALL Pain Relief PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL New World Imports, Inc c93aa5e4-3994-439f-8f14-4e81773ed4e2 2025-12-22 Warnings Exact identifier application number: M013 Acetaminophen Diphenhydramine HCl ACETAMINOPHEN DIPHENHYDRAMINE HCL Granules USA, Inc. 8c9f68e3-fedc-6457-e053-2995a90a045a 2025-12-22 Warnings Exact identifier application number: M013 Aspirin ASPIRIN L.N.K. International, Inc. 35005045-57b2-4ffe-ab70-22d570c1b161 2025-12-22 Warnings Exact identifier application number: M013 Tension Headache Relief ACETAMINOPHEN, CAFFEINE NUVICARE LLC ea4e50e9-2c4d-4e58-b2cb-ab23e91fd50e 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Walmart 175495fd-c561-f813-e063-6294a90aac80 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN WALMART INC 21b22e9f-b6d1-1819-e063-6294a90ae09c 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen and Diphenhydramine HCL ACETAMINOPHEN AND DIPHENHYDRAMINE HCL SAFEWAY f18c1aa2-5f8b-5458-e053-2995a90ab947 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Meijer 181b3148-fa33-c650-e063-6294a90a0de6 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN TOPCO ASSOCIATES LLC 1a00a49e-f9ff-b928-e063-6394a90a4cb5 2025-12-19 Warnings Exact identifier application number: M013
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