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
IngredientStrength
ACETAMINOPHEN160 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f818996c-36d2-4d3d-af3e-39949157edb9Available 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 58 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Neighbor Pharmacy Pain ReliefACETAMINOPHENAmerisource Bergen5101125d-4819-4e4b-a0ee-a0ff8d5a0ab12024-10-30WarningsExact identifier
application number: M013
AcetaminophenPAIN RELIEVERMcKesson9d620700-5d00-475f-e053-2995a90a9a3f2024-10-28WarningsExact identifier
application number: M013
Junior Acetaminophen Ages 6-11ACETAMINOPHENChain Drug Consortiumd356bc9c-66f1-45c3-a455-98c0b8890f782024-10-28WarningsExact identifier
application number: M013
leader AcetaminophenACETAMINOPHENCardinal Health 110, LLC. dba Leader36bdcac9-eed4-40f9-a6f2-4c1e773a6b502024-10-25WarningsExact identifier
application number: M013
GOODYS PMACETAMINOPHEN AND DIPHENHYDRAMINE CITRATEMedtech Products Inc.db5d6c2b-688e-4e88-a42d-0fa2b0d8140b2024-10-25WarningsExact identifier
application number: M013
Goodys Extra StrengthACETAMINOPHEN, ASPIRIN, AND CAFFEINEMedtech Products Inc.16d774cc-4247-4bf8-9b5a-c338ffebda3d2024-10-25WarningsExact identifier
application number: M013
aspirinASPIRINPUBLIX SUPER MARKETS INC9e77ab7a-07e8-42aa-e053-2995a90a0d0e2024-10-24WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENKroger Company5bfd9841-c781-43be-b823-d334893ae6ed2024-10-24WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENH E Badd6952e-9dd5-487c-93e6-337e9d6a48722024-10-24WarningsExact identifier
application number: M013
Dye Free Pain Reliever ChildrensACETAMINOPHENSafeway, Inc.7d55cb42-295f-473a-941d-71825b44a3c02024-10-24WarningsExact identifier
application number: M013
rapid release pain reliefACETAMINOPHENPublix Super Markets Incd0b34133-d69d-47db-bf51-be942769c6122024-10-24WarningsExact identifier
application number: M013
basic care acetaminophenACETAMINOPHENAmazon.com Services LLC00146b91-008d-4b16-95b0-6077f98821be2024-10-24WarningsExact identifier
application number: M013
equate pain relieverACETAMINOPHENWALMART INC.9a20273e-a4d1-4c38-9efb-e6347f8dc14e2024-10-24WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENMARC GLASSMAN, INC.e221905b-a795-c067-e053-2a95a90a02e72024-10-23WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEMARC GLASSMAN, INC.e221bbce-83de-0f03-e053-2995a90abca52024-10-23WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENMARC GLASSMAN, INC.e231c2f6-927c-1ab0-e053-2995a90a61212024-10-23WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENMARC GLASSMAN, INC.e23703bb-6087-7985-e053-2995a90aa5ec2024-10-23WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEMARC GLASSMAN, INC.e237550d-711d-5d87-e053-2995a90affce2024-10-23WarningsExact identifier
application number: M013
AspirinASPIRINHARRIS TEETERa6f15f71-1327-4b71-b9d6-e3e9f02438012024-10-22WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHARRIS TEETER43308b23-7d4f-4e4f-a497-af71920d86aa2024-10-22WarningsExact identifier
application number: M013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58602-167-20586020167201 BOTTLE in 1 CARTON (58602-167-20) / 236 mL in 1 BOTTLE1 bottle2026-07-27NoNoCurrent
58602-167-24586020167241 BOTTLE in 1 CARTON (58602-167-24) / 118 mL in 1 BOTTLE1 bottle2026-07-27NoNoCurrent