FDA.reportPublic FDA data

Pain and Fever

Product NDC
82673-097
Requested package NDC
82673-097-04
11-digit product format
826730097
Labeler code
82673
Product ID
82673-097_b7e4c231-8a35-453e-8512-cc6dc200fa06
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
KinderFarms, LLC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-05-27
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage82673-09782673-097-04DDiscontinued by firm2026-11-06

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
82673-097-04Pain and FeverChildrens118 mL in 1 BOTTLE, PLASTICSUSPENSION1183
82673-097-04Pain and FeverChildrens1 in 1 BOXSUSPENSION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82673-097PAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [KINDERFARMS, LLC]3Legacy NDC, 2 package rows20240411_f33db02a-58f4-41a5-8f1f-4ec64d17f5a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNf33db02a-58f4-41a5-8f1f-4ec64d17f5a13
307668acetaminophen 32 MG/ML Oral SuspensionSCDf33db02a-58f4-41a5-8f1f-4ec64d17f5a13
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYf33db02a-58f4-41a5-8f1f-4ec64d17f5a13
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYf33db02a-58f4-41a5-8f1f-4ec64d17f5a13
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYf33db02a-58f4-41a5-8f1f-4ec64d17f5a13
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYf33db02a-58f4-41a5-8f1f-4ec64d17f5a13
307668APAP 32 MG/ML Oral SuspensionSYf33db02a-58f4-41a5-8f1f-4ec64d17f5a13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82673-097-04826730097041 BOTTLE, PLASTIC in 1 BOX (82673-097-04) > 118 mL in 1 BOTTLE, PLASTIC2022-05-270000-00-00NoNoCurrent