FDA.reportPublic FDA data

childrens acetaminophen

Product NDC
0904-6766
11-digit product format
009046766
Labeler code
0904
Product ID
0904-6766_05bea71d-876d-4a9f-bcb1-12367b7ea2dc
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Major Pharmaceuticals
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-08-13
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct0904-6766DDiscontinued by firm2026-10-05
excluded packagepackage0904-67660904-6766-20DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

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

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct0904-6766DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0904-67660904-6766-20DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6766-20ML - Milliliter0904-6766ca43bd45-a627-4334-b2b5-a159c794138512018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6766CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [MAJOR PHARMACEUTICALS]2Legacy NDC20240530_05bea71d-876d-4a9f-bcb1-12367b7ea2dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNcd9fa7be-59ec-b30e-e053-2a95a90a98f72
307668acetaminophen 32 MG/ML Oral SuspensionSCDcd9fa7be-59ec-b30e-e053-2a95a90a98f72
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYcd9fa7be-59ec-b30e-e053-2a95a90a98f72
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYcd9fa7be-59ec-b30e-e053-2a95a90a98f72
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYcd9fa7be-59ec-b30e-e053-2a95a90a98f72
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYcd9fa7be-59ec-b30e-e053-2a95a90a98f72
307668APAP 32 MG/ML Oral SuspensionSYcd9fa7be-59ec-b30e-e053-2a95a90a98f72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6766-20009046766201 BOTTLE in 1 CARTON (0904-6766-20) > 118 mL in 1 BOTTLE1 bottle2018-08-130000-00-00NoNoCurrent