Infants Pain and Fever

Product NDC
58602-173
11-digit product format
586020173
Labeler code
58602
Product ID
58602-173_e837538d-0515-4f99-b04c-fda63b28777e
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Aurohealth LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-18
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
Infants 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
e837538d-0515-4f99-b04c-fda63b28777eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-173-11Infants Pain and Fever1 in 1 CARTONSUSPENSION11
58602-173-11Infants Pain and Fever60 mL in 1 BOTTLESUSPENSION601

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 13 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meijer Effervescent Antacid and Pain ReliefASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEMeijer Distribution Inc7305972b-aa0f-4daa-e053-2991aa0adfd72026-05-11WarningsExact identifier
application number: M013
Genexa Kids Pain and FeverACETAMINOPHENGenexa, Inc.091dd1e7-2484-cdbf-e063-6394a90a21892026-05-11WarningsExact identifier
application number: M013
Little Remedies Infant Fever/Pain RelieverACETAMINOPHENMedtech Products Inc.af5c3b3b-079f-4ee6-a9a4-a13ee8cd99a52026-05-11WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINWal-Mart Stores Inc093e0458-9975-456f-8950-8273c8890b3c2026-05-11WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENCVS PHARMACYafacdc0b-fb65-464e-91b8-e82ba7ecde442026-05-11WarningsExact identifier
application number: M013
CHILDRENS PAIN RELIEVER and FEVER REDUCER CHERRYACETAMINOPHENDeMoulas Market Basket192f7c24-a4aa-4c05-8d64-5e7e0bf7a1012026-05-09WarningsExact identifier
application number: M013
CHILDRENS PAIN RELIEVER and FEVER REDUCER GRAPEACETAMINOPHENDeMoulas Market Basket0ff5c86e-d84b-42ad-b749-636ab2e3734e2026-05-09WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINRugby Laboratories939fce7e-55df-4dc5-916b-a533448e962f2026-05-08WarningsExact identifier
application number: M013
Kids Pain and FeverACETAMINOPHENGenexa Inc.f7e6e984-f0c3-ed40-e053-6294a90a89f72026-05-08WarningsExact identifier
application number: M013
Genexa Infants Pain and FeverACETAMINOPHENGenexa Inc.c59cbf0e-1381-4dd2-e053-2a95a90a853a2026-05-08WarningsExact identifier
application number: M013
Genexa Acetaminophen Extra StrengthACETAMINOPHENGenexa Inc.d6f968ca-719f-5a68-e053-2995a90a4afa2026-05-08WarningsExact identifier
application number: M013
Kids Pain and FeverACETAMINOPHENGenexa Inc.a7bd0b92-6f85-6175-e053-2995a90ab8372026-05-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENBryant Ranch Prepack816b65d7-e53f-44c4-a418-074279d4b2af2026-05-08WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEAmerisource Bergen566dbd02-5e04-4461-8f5f-9fb58a42a3752026-05-07WarningsExact identifier
application number: M013
Back and Body Extra StrengthASPIRIN, CAFFEINEDOLGENCORP, LLCd4c0c81b-9176-47d0-a5e4-a584406078d92026-05-07WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENPinnacle RX LLC513cf0e1-6874-9402-e063-6294a90aedc62026-05-07WarningsExact identifier
application number: M013
Infants Pain and Fever Cherry FlavorACETAMINOPHENGenexa Inc.19215ea7-d55f-8d81-e063-6294a90a49242026-05-07WarningsExact identifier
application number: M013
up and up acetaminophen infantsACETAMINOPHENTarget Corporationc1dd8330-fb6b-4d1f-9484-c199dc69214d2026-05-07WarningsExact identifier
application number: M013
Extra Strength AspirinASPIRINHHH Pharmaceuticals90d457bb-79a7-4759-8ee7-6abffbe1e5492026-05-06WarningsExact identifier
application number: M013
Aspirin 81mg Enteric CoatedASPIRINHHH Pharmaceuticalsd81aec73-c7c1-4c52-80f6-fb0e32caf7aa2026-05-06WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNe837538d-0515-4f99-b04c-fda63b28777e1
307668acetaminophen 32 MG/ML Oral SuspensionSCDe837538d-0515-4f99-b04c-fda63b28777e1
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYe837538d-0515-4f99-b04c-fda63b28777e1
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYe837538d-0515-4f99-b04c-fda63b28777e1
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYe837538d-0515-4f99-b04c-fda63b28777e1
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYe837538d-0515-4f99-b04c-fda63b28777e1
307668APAP 32 MG/ML Oral SuspensionSYe837538d-0515-4f99-b04c-fda63b28777e1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNe837538d-0515-4f99-b04c-fda63b28777e1
307668acetaminophen 32 MG/ML Oral SuspensionSCDe837538d-0515-4f99-b04c-fda63b28777e1
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYe837538d-0515-4f99-b04c-fda63b28777e1
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYe837538d-0515-4f99-b04c-fda63b28777e1
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYe837538d-0515-4f99-b04c-fda63b28777e1
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYe837538d-0515-4f99-b04c-fda63b28777e1
307668APAP 32 MG/ML Oral SuspensionSYe837538d-0515-4f99-b04c-fda63b28777e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58602-173-11586020173111 BOTTLE in 1 CARTON (58602-173-11) / 60 mL in 1 BOTTLE1 bottle2026-05-18NoNoCurrent