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 firm2026-10-05

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

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain and Fever ChildrensACETAMINOPHENKinderFarms, LLCf33db02a-58f4-41a5-8f1f-4ec64d17f5a12024-04-10WarningsExact identifier
ndc (package): 82673-097-04
ndc (product): 82673-097
ndc11 (package): 82673009704

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