FDA.reportPublic FDA data

Pain Cream

Product NDC
79804-260
11-digit product format
798040260
Labeler code
79804
Product ID
79804-260_ece658cf-430d-382e-e053-2995a90a9563
Type
HUMAN OTC DRUG
Nonproprietary name
Analgesic
Dosage form
CREAM
Route
TOPICAL
Labeler
Eagle Labs Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-08-22
Marketing end
0000-00-00
Substance
CAMPHOR (SYNTHETIC); MENTHOL
Active strength
0 g/g; g/g
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct79804-260IInactivated by FDA2026-10-12
excluded packagepackage79804-26079804-260-02IInactivated by FDA2026-10-12

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
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct79804-260IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage79804-26079804-260-02IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79804-260-022024-04-16C16284748780-11030e365-1983-111a-e063-dadaa90a10e2Pain Cream
79804-260-022024-01-30C16284748780-11030e365-1983-111a-e063-dadaa90a10e2Pain Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79804-260-02Pain Cream59 g in 1 PACKAGECREAM593

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79804-260PAIN CREAM (ANALGESIC) CREAM [EAGLE LABS INC.]3Legacy NDC, 1 package rows20240418_ddc04680-896d-4664-b010-359d1b1107df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2610119camphor 5 % / menthol 6 % Topical CreamPSNddc04680-896d-4664-b010-359d1b1107df3
2610119camphor 50 MG/ML / menthol 60 MG/ML Topical CreamSCDddc04680-896d-4664-b010-359d1b1107df3
2610119camphor 5 % / menthol 6 % Topical CreamSYddc04680-896d-4664-b010-359d1b1107df3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79804-260-027980402600259 g in 1 PACKAGE (79804-260-02) 59 g2022-08-230000-00-00NoNoCurrent