FDA.reportPublic FDA data

RegenarX

Product NDC
84761-0008
Requested package NDC
84761-0008-4
11-digit product format
847610008
Labeler code
84761
Product ID
84761-0008_590f4598-cde2-ae44-e063-6394a90a0454
Type
HUMAN OTC DRUG
Nonproprietary name
CASTOR
Dosage form
OIL
Route
TOPICAL
Labeler
Tejeda Enterprises Incorporated
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2026-06-01
Substance
TEA TREE OIL; EUGENIA CARYOPHYLLUS (CLOVE) STEM OIL; ARNICA MONTANA ROOT; AZADIRACHTA INDICA SEED OIL; RICINUS COMMUNIS (CASTOR) SEED OIL; HYPERICUM OIL
Active strength
10.86; 21.71; 54.28; 54.28; 64.4; 10.86 g/236mL; g/236mL; g/236mL; g/236mL; g/236mL; g/236mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
RegenarX
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TEA TREE OIL10.86 g/236mL
EUGENIA CARYOPHYLLUS (CLOVE) STEM OIL21.71 g/236mL
ARNICA MONTANA ROOT54.28 g/236mL
AZADIRACHTA INDICA SEED OIL54.28 g/236mL
RICINUS COMMUNIS (CASTOR) SEED OIL64.4 g/236mL
HYPERICUM OIL10.86 g/236mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VIF565UC2GInternal UNII lookup
9368YZM9M4Internal UNII lookup
MUE8Y11327Internal UNII lookup
4DKJ9B3K2TInternal UNII lookup
D5340Y2I9GInternal UNII lookup
OZU2FC70HYInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
55f75e79-da6a-d91b-e063-6294a90afee1Available on FDA.report

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RegenarXCASTORTejeda Enterprises Incorporated55f75e79-da6a-d91b-e063-6294a90afee12026-08-15WarningsExact identifier
ndc (package): 84761-0008-4
ndc (product): 84761-0008
ndc11 (package): 84761000804

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84761-0008-484761000804236 mL in 1 BOTTLE, WITH APPLICATOR (84761-0008-4) 236 ml2026-06-01NoNoCurrent