Childrens Pain and Fever

Product NDC
58602-166
11-digit product format
586020166
Labeler code
58602
Product ID
58602-166_5ada044e-50e8-4874-ac04-df5f1f9e735d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Aurohealth LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-07-23
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
5ada044e-50e8-4874-ac04-df5f1f9e735dAvailable 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 42 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens AcetaminophenACETAMINOPHENBryant Ranch Prepack190bb2dc-92b4-4b59-a47f-a0251df8261c2025-07-29WarningsExact identifier
application number: M013
Extra Strength NiteTime Pain ReliefACETAMINOPHEN 500 MG,DIPHENHYDRAMINE HYDROCHLORIDE 25 MG TABLETWALGREENSc25c75c7-157f-1c0d-e053-2995a90a2e3c2025-07-25WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEWalmart Inc.21ab3d58-bb0e-3e51-e063-6294a90ad4152025-07-25WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLC3a935584-6045-0a58-e063-6394a90a40c42025-07-23WarningsExact identifier
application number: M013
DR. SANA PAIN AND FEVER FOR ChildrenACETAMINOPHENGADAL Laboratories, Inc8a22a5ba-8623-4cca-8723-52b4954034612025-07-23WarningsExact identifier
application number: M013
DuralginaACETAMINOPHENMenper Distributors Inc.bb31f66c-80a9-4bdb-983b-cef5d21de5ff2025-07-22WarningsExact identifier
application number: M013
GesteiraACETAMINOPHENMenper Distributors, Inc.5a907289-564c-491b-98d5-d7f43eaaa1b22025-07-22WarningsExact identifier
application number: M013
Extra strength Acetaminophen PMACETAMINOPHEN 500MG/ DIPHENHYDRAMINE HCL 25MGTIME CAP LABS INC010c5c98-fc67-a9c3-e063-6394a90aa6402025-07-21WarningsExact identifier
application number: M013
childrens pain and feverACETAMINOPHENMeijer Distribution Inc44d50d79-6e47-429f-8cbe-6fcac46677322025-07-18WarningsExact identifier
application number: M013
ADWE Childrens Pain FeverACETAMINOPHENRARITAN PHARMACEUTICALS INC79a3232f-0211-4c8a-acee-4f87e06ffc262025-07-17WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWalmart Inc.24d191ca-a0c4-e1a8-e063-6394a90a7a2a2025-07-16WarningsExact identifier
application number: M013
EXTRA STRENGTH HEADACHE RELIEFACETAMINOPHEN ASPIRIN CAFFEINEWAL-MART STORES INCd97073cd-b5d7-8c09-e053-2a95a90a89382025-07-16WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENBETTER LIVING BRANDS LLC.f3005d0c-424e-0ab3-e053-2995a90a1c102025-07-16WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDemoulas Super Markets, Inc397fa6e1-37b2-8f51-e063-6394a90a7b942025-07-16WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDemoulas Super Markets, Inc39800c27-f39f-cd60-e063-6394a90acd552025-07-16WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDemoulas Super Markets, Inc397f2b63-733e-5b44-e063-6394a90a97182025-07-16WarningsExact identifier
application number: M013
EXTRA STRENGTH PAIN RELIEFACETAMINOPHEN, ASPIRIN, CAFFEINEBETTER LIVING BRANDS, LLCeb6026d5-d88a-f6b3-e053-2a95a90a5b202025-07-15WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDESafewayf9597abc-3f01-4b94-8078-228e0b74677e2025-07-15WarningsExact identifier
application number: M013
Berkley and Jensen Pain ReliefACETAMINOPHENBJWCd3ee3341-93b8-487c-921e-2892d213efbb2025-07-15WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINECVS Pharmacy9e459853-5951-4ae7-88a6-85b502e9dd412025-07-14WarningsExact identifier
application number: M013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58602-166-20586020166201 BOTTLE in 1 CARTON (58602-166-20) / 236 mL in 1 BOTTLE1 bottle2026-07-23NoNoCurrent
58602-166-24586020166241 BOTTLE in 1 CARTON (58602-166-24) / 118 mL in 1 BOTTLE1 bottle2026-07-23NoNoCurrent