FDA.reportPublic FDA data

INFANTS Pain and Fever

Product NDC
58602-172
11-digit product format
586020172
Labeler code
58602
Product ID
58602-172_b3f57af5-661f-4534-9eed-76e431f338db
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
b3f57af5-661f-4534-9eed-76e431f338dbAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-172-11INFANTS Pain and Fever1 in 1 CARTONSUSPENSION11
58602-172-11INFANTS 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 8 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AspirinASPIRINUnited Natural Foods, Inc. dba UNFI19c7f832-d7ec-4dcc-8aa4-f4cbf64c9ff62026-07-02WarningsExact identifier
application number: M013
pain relief EXTRA STRENGTHACETAMINOPHENMeijer Distribution, Inc.ae84eb7e-a70b-4311-b2dc-ad153047a5162026-07-01WarningsExact identifier
application number: M013
Aspirin 325 mgASPIRINHi-Tech Nutraceuticals, LLCb3426a9a-ea99-da30-e053-2995a90a1e4b2026-07-01WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINESalado Sales, Inc.ca21d576-be3c-495d-9dbd-ed514bf65da72026-07-01WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENMeijer Distribution Inc4e08a7cb-3894-84c3-e063-6394a90a0b422026-06-30WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINEWal-Mart Stores Inc9b1201af-c802-4e19-b192-bbbf34367db42026-06-30WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENP & L Development, LLCfc841cba-8f4f-407b-97de-0422977515bd2026-06-30WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEUnited Natural Foods, Inc. dba UNFIb6ff2b34-51ee-41bc-8b7d-7520ade0bf362026-06-30WarningsExact identifier
application number: M013
MedlineASPIRINMedline Industries, LP4b0c569a-ed7a-e104-e063-6394a90a6d542026-06-29WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLWALMART INC.e50b3f60-b827-426c-8e78-8447c89130fe2026-06-29WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN, DIPHENHYDRAMINE HCLChain Drug Marketing Association, Inc.e58417f4-3575-4433-ac2e-b7bf9fe8ba102026-06-29WarningsExact identifier
application number: M013
Dr Kids Pain and FeverACETAMINOPHENCalmCo LLC5534a784-a7b1-5599-e063-6294a90a79612026-06-27WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENSelect Consumer Group LLC529d3a51-a248-7c02-e063-6294a90a10ae2026-06-27WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENSportpharm LLC830ffcaa-7ff8-4732-bc84-6a8c5e78722d2026-06-25WarningsExact identifier
application number: M013
AspirinASPIRINStrategic Sourcing Services LLCea2ef485-429e-4c63-ba7b-0a6b32892ad22026-06-25WarningsExact identifier
application number: M013
AspirinASPIRINChain Drug Marketing Association, Inc.055d8420-c189-4a9e-acdc-21627935c8eb2026-06-25WarningsExact identifier
application number: M013
AspirinASPIRINTopco Associates, LLC5f32cf74-dbea-496c-ba23-2040ea354f402026-06-25WarningsExact identifier
application number: M013
AspirinASPIRINSalado Sales, Inc.cf3139a5-e36e-48e3-bb6c-e102b0cec5552026-06-25WarningsExact identifier
application number: M013
Pain Relief AspirinASPIRINRite Aid Corporationbd69d3d2-5d38-47c6-98a6-124f7a43b8b02026-06-25WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINWalgreen Company0b27c0fd-7ea8-4588-9169-5ad4e8df77ef2026-06-25WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNb3f57af5-661f-4534-9eed-76e431f338db1
307668acetaminophen 32 MG/ML Oral SuspensionSCDb3f57af5-661f-4534-9eed-76e431f338db1
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYb3f57af5-661f-4534-9eed-76e431f338db1
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYb3f57af5-661f-4534-9eed-76e431f338db1
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYb3f57af5-661f-4534-9eed-76e431f338db1
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYb3f57af5-661f-4534-9eed-76e431f338db1
307668APAP 32 MG/ML Oral SuspensionSYb3f57af5-661f-4534-9eed-76e431f338db1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNb3f57af5-661f-4534-9eed-76e431f338db1
307668acetaminophen 32 MG/ML Oral SuspensionSCDb3f57af5-661f-4534-9eed-76e431f338db1
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYb3f57af5-661f-4534-9eed-76e431f338db1
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYb3f57af5-661f-4534-9eed-76e431f338db1
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYb3f57af5-661f-4534-9eed-76e431f338db1
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYb3f57af5-661f-4534-9eed-76e431f338db1
307668APAP 32 MG/ML Oral SuspensionSYb3f57af5-661f-4534-9eed-76e431f338db1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58602-172-11586020172111 BOTTLE in 1 CARTON (58602-172-11) / 60 mL in 1 BOTTLE1 bottle2026-05-18NoNoCurrent