FDA.reportPublic FDA data

Florexa

Product NDC
82160-125
11-digit product format
821600125
Labeler code
82160
Product ID
82160-125_d393fd55-c805-8a11-e053-2995a90a88dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eflornithine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Pella Pharmaceuticals Co. Ltd
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2012-02-09
Marketing end
0000-00-00
Substance
EFLORNITHINE HYDROCHLORIDE
Active strength
4170 mg/30g
Pharmacologic classes
Antiprotozoal [EPC], Decarboxylase Inhibitor [EPC], Decarboxylase Inhibitors [MoA]
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 productproduct82160-125IInactivated by FDA2026-08-17
excluded packagepackage82160-12582160-125-01IInactivated by FDA2026-08-17

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage82160-125-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage82160-125-01bd6a592717d7…303034d00443…

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82160-125-01Florexa30 g in 1 TUBECREAM30128
82160-125-01Florexa1 in 1 CARTONCREAM1128

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82160-125FLOREXA (EFLORNITHINE HYDROCHLORIDE) CREAM [PELLA PHARMACEUTICALS CO. LTD]128Legacy NDC, 2 package rows20250101_d0842c09-4f4f-5209-e053-2a95a90a54d6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82160-125-01821600125011 TUBE in 1 CARTON (82160-125-01) > 30 g in 1 TUBE1 tube2012-02-090000-00-00NoNoCurrent