FDA.reportPublic FDA data

Curoxen

Product NDC
71042-001
11-digit product format
710420001
Labeler code
71042
Product ID
71042-001_77431f1d-0446-3efc-e053-2991aa0a332b
Type
HUMAN OTC DRUG
Nonproprietary name
Olive Extract, Calendula
Dosage form
OINTMENT
Route
TOPICAL
Labeler
OrganiCare Nature's Science, LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2016-10-21
Marketing end
0000-00-00
Substance
OLEA EUROPAEA FRUIT VOLATILE OIL; CALENDULA OFFICINALIS FLOWERING TOP
Active strength
2 [hp_X]/14g; [hp_X]/14g
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71042-001DDiscontinued by firm2026-10-05
excluded packagepackage71042-00171042-001-01DDiscontinued by firm2026-10-05
excluded packagepackage71042-00171042-001-14DDiscontinued by firm2026-10-05
excluded packagepackage71042-00171042-001-28DDiscontinued 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 packagepackage71042-00171042-001-28DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71042-00171042-001-01DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71042-001CUROXEN (OLIVE EXTRACT, CALENDULA) OINTMENT [ORGANICARE NATURE'S SCIENCE, LLC]8Legacy NDC20241215_3f643251-f97b-1a12-e054-00144ff88e88.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71042-001-01710420001011 POUCH in 1 BLISTER PACK (71042-001-01) > 1 g in 1 POUCH1 pouch2017-01-190000-00-00NoNoCurrent
71042-001-14710420001141 TUBE in 1 CARTON (71042-001-14) > 14 g in 1 TUBE1 tube2016-10-210000-00-00NoNoCurrent
71042-001-28710420001281 TUBE in 1 CARTON (71042-001-28) > 28.3 g in 1 TUBE1 tube2017-12-200000-00-00NoNoCurrent