NDC 51316-401

This exact product or package identity exists in FDA auxiliary data but is not present in the current primary NDC product table. The package identity is preserved; status rows are reported source observations, not medical conclusions.

Requested NDC: 51316-401
Product root: 51316-401
Identity scope: Product
Primary current NDC product row: Not present

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	51316-401		E	Excluded after deficient or non-compliant submission was not corrected	2026-10-05
excluded package	package	51316-401	51316-401-72	E	Excluded after deficient or non-compliant submission was not corrected	2026-10-05
excluded package	package	51316-401	51316-401-81	E	Excluded after deficient or non-compliant submission was not corrected	2026-10-05

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen and Ibuprofen	ACETAMINOPHEN AND IBUPROFEN	CVS	2f3a6c80-0b84-c469-e063-6394a90aea8e	2025-07-01	Warnings	Exact identifier ndc (product): 51316-401

Reported adverse events (FAERS/openFDA)#

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