FDA.reportPublic FDA data

Pain Relief Fever Reducer

Product NDC
80272-002
11-digit product format
802720002
Labeler code
80272
Product ID
80272-002_10e22b9b-a5c6-4ede-9928-ae885a87eb8e
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Ellywell, LLC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-09-30
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 productproduct80272-002DDiscontinued by firm2026-10-12
excluded packagepackage80272-00280272-002-04DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80272-002-04Pain Relief Fever Reducerchildren1 in 1 BOXSUSPENSION16
80272-002-04Pain Relief Fever Reducerchildren118 mL in 1 BOTTLE, PLASTICSUSPENSION1186

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80272-002PAIN RELIEF FEVER REDUCER CHILDREN (ACETAMINOPHEN) SUSPENSION [ELLYWELL, LLC]6Legacy NDC, 2 package rows20241016_92f26bb4-da58-4db4-83bc-aec1ebab2dbf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN92f26bb4-da58-4db4-83bc-aec1ebab2dbf6
307668acetaminophen 32 MG/ML Oral SuspensionSCD92f26bb4-da58-4db4-83bc-aec1ebab2dbf6
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY92f26bb4-da58-4db4-83bc-aec1ebab2dbf6
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY92f26bb4-da58-4db4-83bc-aec1ebab2dbf6
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY92f26bb4-da58-4db4-83bc-aec1ebab2dbf6
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY92f26bb4-da58-4db4-83bc-aec1ebab2dbf6
307668APAP 32 MG/ML Oral SuspensionSY92f26bb4-da58-4db4-83bc-aec1ebab2dbf6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80272-002-04802720002041 BOTTLE, PLASTIC in 1 BOX (80272-002-04) > 118 mL in 1 BOTTLE, PLASTIC2020-09-300000-00-00NoNoCurrent