FDA.reportPublic FDA data

Pain and Fever

Product NDC
62011-0461
11-digit product format
620110461
Labeler code
62011
Product ID
62011-0461_74b80087-3877-4a51-a750-a4b1d87ecc33
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-09-22
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct62011-0461DDiscontinued by firm2026-10-16
excluded packagepackage62011-046162011-0461-1DDiscontinued by firm2026-10-16

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62011-0461-1Pain and FeverChildrens118 mL in 1 BOTTLE, PLASTICSUSPENSION1185
62011-0461-1Pain and FeverChildrens1 in 1 BOXSUSPENSION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62011-0461-1ML - Milliliter62011-0461467b92ac-49c9-46a6-bbbc-2e1e61ab37b212021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62011-0461PAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [STRATEGIC SOURCING SERVICES LLC]5Legacy NDC, 2 package rows20240530_eceed6cd-c631-4a42-a212-87092aafb647.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNeceed6cd-c631-4a42-a212-87092aafb6475
307668acetaminophen 32 MG/ML Oral SuspensionSCDeceed6cd-c631-4a42-a212-87092aafb6475
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYeceed6cd-c631-4a42-a212-87092aafb6475
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYeceed6cd-c631-4a42-a212-87092aafb6475
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYeceed6cd-c631-4a42-a212-87092aafb6475
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYeceed6cd-c631-4a42-a212-87092aafb6475
307668APAP 32 MG/ML Oral SuspensionSYeceed6cd-c631-4a42-a212-87092aafb6475

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62011-0461-1620110461011 BOTTLE, PLASTIC in 1 BOX (62011-0461-1) > 118 mL in 1 BOTTLE, PLASTIC2020-09-220000-00-00NoNoCurrent