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 51 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pediacare Childrens Acetaminophen GrapeACETAMINOPHENRANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH596372c7-eca3-4527-8e22-ab0751e2526b2024-12-30WarningsExact identifier
application number: M013
Bayer Genuine AspirinBAYER GENUINE ASPIRINLil' Drug Store Products, Inc.d17834d7-cb3e-6bf2-e053-2a95a90ae5c12024-12-30WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHEN 500 MG, FILM-COATED CAPLETLil' Drug Store Products, Inc.e5fd2b46-683e-4cf5-e053-2995a90a55122024-12-30WarningsExact identifier
application number: M013
Night Time Severe Cold and Cough ReliefACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLChain Drug Consortium, LLCc8e9b57b-83e9-46c5-9791-02c4c2b940042024-12-29WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INC.1608b4f0-bf20-4024-b8f2-20a4df7a4b212024-12-26WarningsExact identifier
application number: M013
AspirinASPIRINAdvance Pharmaceutical Inc.f6a9ea44-08b8-4a33-bfbd-68cb2d852c392024-12-26WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INCcfc7eac3-35be-4002-b8ef-be1dfc8caf692024-12-26WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INCa3031139-4709-43f2-95a8-89840c595f7f2024-12-26WarningsExact identifier
application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mgACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MGWALGREENS CO.98bb28ed-d146-ca3d-e053-2a95a90a9eaf2024-12-26WarningsExact identifier
application number: M013
Acetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mgACETAMINOPHEN 500MG CAFFEINE 60MG PYRILAMINE MALEATE 15MGWALGREENS CO.982faa74-d498-cd1e-e053-2995a90afa1e2024-12-25WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAptaPharma Inc.11bf6e1b-aed9-4f8f-9f03-ea911ae9f7022024-12-23WarningsExact identifier
application number: M013
Rugby Regular Strength AcetaminophenACETAMINOPHENRUGBY LABORATORIES295b0d00-4d4a-405f-9325-d01c5d4f3ed42024-12-20WarningsExact identifier
application number: M013
Walgreens Pain Relief PowderASPIRIN AND CAFFEINEWalgreens Co.61493d34-2432-4683-9b32-e1851a4337be2024-12-18WarningsExact identifier
application number: M013
Reese Headache PowdersASPIRIN AND CAFFEINEReese Pharmaceutical Co386f7a6c-4bfc-4140-a67b-07f6b520d58f2024-12-18WarningsExact identifier
application number: M013
NobleAid PAIN RELIEVERASPIRINNoble Otc LLCaa08e488-2f69-4d7e-86ba-ccfad563edcf2024-12-18WarningsExact identifier
application number: M013
Dollar General Headache PowdersASPIRIN AND CAFFEINEDolgencorp, LLC11b0271b-d65c-49c4-a081-d71044a0e04c2024-12-18WarningsExact identifier
application number: M013
Family Wellness Pain Relief PowderASPIRIN AND CAFFEINEFamily Dollar Services Incb2e55de7-3c36-49cc-8f7f-1013fd1ec3592024-12-18WarningsExact identifier
application number: M013
Best Choice Pain Relief PowderASPIRIN AND CAFFEINEValue Mercha95b9b22-ea5c-4a02-b35d-c8ae1e1176042024-12-18WarningsExact identifier
application number: M013
Walmart Pain Relief PowderASPIRIN AND CAFFEINEWalmartc69aa61f-6a74-40a3-8737-195fa545e2612024-12-18WarningsExact identifier
application number: M013
Quality Choice Pain Relief PowderASPIRIN AND CAFFEINEChain Drug Marketing Association8e1f4057-4968-4523-9b3f-55aea421b6742024-12-18WarningsExact 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