FDA.reportPublic FDA data

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 40 of 83 · 1,657 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens TYLENOLACETAMINOPHENKenvue Brands LLC79669930-f744-4bb1-8325-b75951489b642025-09-17WarningsExact identifier
application number: M013
childrens acetaminophenACETAMINOPHENUnited Natural Foods, Inc. dba UNFIf4642725-f953-4aa8-8106-f468d8220f652025-09-17WarningsExact identifier
application number: M013
Pain and Fever ChildrensACETAMINOPHENWal-Mart Stores Inc462580aa-712d-43bb-846d-631db3e79c1d2025-09-16WarningsExact identifier
application number: M013
Pain and Fever ChildrensACETAMINOPHENWal-Mart Stores Inc1729d4b1-ca3b-4360-8328-2484f239440a2025-09-15WarningsExact identifier
application number: M013
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLL.N.K. International, Inc.ff199db8-c7ea-4b6e-ad8b-3ceeca883d922025-09-15WarningsExact identifier
application number: M013
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLFOODHOLD U.S.A., LLCfdd7ce80-d6be-41b9-affd-d024cf306b502025-09-12WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN, DIPHENHYDRAMINE HCLCOSTCO WHOLESALE CORPORATIONe03dfa65-1a9c-4284-89cf-19ccbaabfa322025-09-12WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHENINGLES MARKETS, INC.3e89240b-0e27-fde4-e063-6394a90a779f2025-09-11WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHENINGLES MARKETS, INC.10e4bbe2-a47e-ff16-e063-6294a90a56a12025-09-11WarningsExact identifier
application number: M013
Back and Body Extra StrengthASPIRIN, CAFFEINEL.N.K. International, Inc.6d254f3f-8223-4a6e-a3b2-f53f145ff3dc2025-09-11WarningsExact identifier
application number: M013
Aspirin 81 mg Low DoseASPIRINHEB926fe7b6-9607-469f-912f-4019891067a92025-09-10WarningsExact identifier
application number: M013
Bayer Genuine AspirinASPIRINUnifirst First Aid Corporation356e4ff4-a7f1-4a50-9b86-2555e232b3002025-09-09WarningsExact identifier
application number: M013
Medique at Home AspirinASPIRINUnifirst First Aid Corporationb5a469c1-9ab4-5bd7-e053-2995a90a86d12025-09-09WarningsExact identifier
application number: M013
Medique Products AspirinASPIRINUnifirst First Aid Corporation9b28fed0-a993-ca72-e053-2995a90ac7fd2025-09-09WarningsExact identifier
application number: M013
Unishield AspirinASPIRINUnishieldba106b20-32ac-df90-e053-2995a90adaef2025-09-09WarningsExact identifier
application number: M013
Medi First Pain AcheASPIRIN,CAFFEINEUnifirst First Aid Corporatione82d02d5-3e44-a8f8-e053-2a95a90a26882025-09-09WarningsExact identifier
application number: M013
Medique at Home Back Pain ReliefMAGNESIUM SALICYLATEUnifirst First Aid Corporatione56c4aef-fa0b-74db-e053-2a95a90a97452025-09-09WarningsExact identifier
application number: M013
Travel Savvy AspirinASPIRINBellegrove Medical Supply, Inc.bae80044-ad7f-3bf5-e053-2995a90a42f92025-09-09WarningsExact identifier
application number: M013
McKesson AspirinASPIRINMcKesson Medical-Surgicaldabd741e-e11c-52c1-e053-2a95a90a91d52025-09-09WarningsExact identifier
application number: M013
Travel Savvy Non-AspirinACETAMINOPHEN 325MGBellegrove Medical Supply, Inc.6ab08633-5d5a-42b2-e053-2991aa0ab41a2025-09-09WarningsExact 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