Pain and Fever

Product NDC
0363-4501
Requested package NDC
0363-4501-08
11-digit product format
003634501
Labeler code
0363
Product ID
0363-4501_9ff73927-156a-4142-923b-3026cd4c07ff
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Walgreen Company
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2005-02-25
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
160 mg/1
NDC exclude flag
No
Listing certified through
2024-12-31
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 packagepackage0363-45010363-4501-08DDiscontinued by firm2026-10-15

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 · 1 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 packagepackage0363-45010363-4501-08DDiscontinued 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
0363-4501-08EA - Each0363-4501fc371fdf-1f02-4360-a2eb-f26c53d5e42d12019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-4501PAIN AND FEVER CHILDRENS (ACETAMINOPHEN) TABLET, CHEWABLE [WALGREEN COMPANY]11Legacy NDC20240829_fa12f86a-d82a-4de5-8cd1-2151021b5df3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-4501-08003634501084 BLISTER PACK in 1 CARTON (0363-4501-08) > 6 TABLET, CHEWABLE in 1 BLISTER PACK4 blister pack2005-02-250000-00-00NoNoCurrent