FDA.reportPublic FDA data

Arnica Montana Nartex

Product NDC
34666-001
Requested package NDC
34666-001-30
11-digit product format
346660001
Labeler code
34666
Product ID
34666-001_45b54da6-f73a-503c-e063-6394a90a96ea
Type
HUMAN OTC DRUG
Nonproprietary name
Arnica montana, Hamamelis Virginiana
Dosage form
CREAM
Route
TOPICAL
Labeler
NARTEX LABORATORIOS HOMEOPATICOS SA DE CV
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2007-06-01
Substance
ARNICA MONTANA; HAMAMELIS VIRGINIANA LEAF
Active strength
1.73; .0178 g/29.7g; g/29.7g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Arnica Montana Nartex
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARNICA MONTANA1.73 g/29.7g
HAMAMELIS VIRGINIANA LEAF.0178 g/29.7g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O80TY208ZWInternal UNII lookup
T07U1161SVInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d1407fcf-ae2e-4dac-95bf-6a5f0b21f3a6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34666-001-10Arnica Montana Nartex29.7 g in 1 TUBECREAM29.77
34666-001-10Arnica Montana Nartex1 in 1 CARTONCREAM17
34666-001-20Arnica Montana Nartex1 in 1 CARTONCREAM12
34666-001-20Arnica Montana Nartex99.79 g in 1 TUBECREAM99.792
34666-001-30Arnica Montana Nartex74 g in 1 TUBECREAM741
34666-001-30Arnica Montana Nartex1 in 1 CARTONCREAM11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZWARNICA MONTANA NARTEX (ARNICA MONTANA, HAMAMELIS VIRGINIANA) CREAM [NARTEX LABORATORIOS HOMEOPATICOS SA DE CV]4
HAMAMELIS VIRGINIANA LEAFACTIVE INGREDIENTT07U1161SVARNICA MONTANA NARTEX (ARNICA MONTANA, HAMAMELIS VIRGINIANA) CREAM [NARTEX LABORATORIOS HOMEOPATICOS SA DE CV]4
ARNICA MONTANAACTIVE MOIETYO80TY208ZWARNICA MONTANA NARTEX (ARNICA MONTANA, HAMAMELIS VIRGINIANA) CREAM [NARTEX LABORATORIOS HOMEOPATICOS SA DE CV]4
HAMAMELIS VIRGINIANA LEAFACTIVE MOIETYT07U1161SVARNICA MONTANA NARTEX (ARNICA MONTANA, HAMAMELIS VIRGINIANA) CREAM [NARTEX LABORATORIOS HOMEOPATICOS SA DE CV]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXARNICA MONTANA NARTEX (ARNICA MONTANA, HAMAMELIS VIRGINIANA) CREAM [NARTEX LABORATORIOS HOMEOPATICOS SA DE CV]4
LANOLININACTIVE INGREDIENT7EV65EAW6HARNICA MONTANA NARTEX (ARNICA MONTANA, HAMAMELIS VIRGINIANA) CREAM [NARTEX LABORATORIOS HOMEOPATICOS SA DE CV]4
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEARNICA MONTANA NARTEX (ARNICA MONTANA, HAMAMELIS VIRGINIANA) CREAM [NARTEX LABORATORIOS HOMEOPATICOS SA DE CV]4
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UARNICA MONTANA NARTEX (ARNICA MONTANA, HAMAMELIS VIRGINIANA) CREAM [NARTEX LABORATORIOS HOMEOPATICOS SA DE CV]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUARNICA MONTANA NARTEX (ARNICA MONTANA, HAMAMELIS VIRGINIANA) CREAM [NARTEX LABORATORIOS HOMEOPATICOS SA DE CV]4
WATERINACTIVE INGREDIENT059QF0KO0RARNICA MONTANA NARTEX (ARNICA MONTANA, HAMAMELIS VIRGINIANA) CREAM [NARTEX LABORATORIOS HOMEOPATICOS SA DE CV]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34666-001ARNICA MONTANA NARTEX (ARNICA MONTANA, HAMAMELIS VIRGINIANA) CREAM [NARTEX LABORATORIOS HOMEOPATICOS SA DE CV]5Current NDC, Legacy NDC, 2 package rows20191227_d1407fcf-ae2e-4dac-95bf-6a5f0b21f3a6.zip
34666-001ARNICA MONTANA NARTEX (ARNICA MONTANA, HAMAMELIS VIRGINIANA) CREAM [NARTEX LABORATORIOS HOMEOPATICOS SA DE CV]2Current NDC, Legacy NDC, 2 package rows20211230_cd114ace-c040-9e1b-e053-2a95a90a418b.zip
34666-001ARNICA MONTANA NARTEX (ARNICA MONTANA, HAMAMELIS VIRGINIANA) CREAM [NARTEX LABORATORIOS HOMEOPATICOS SA DE CV]1Current NDC, Legacy NDC, 2 package rows20220124_d63b84e1-24c1-6c6c-e053-2995a90a22ce.zip

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arnica Montana NartexARNICA MONTANA, HAMAMELIS VIRGINIANANARTEX LABORATORIOS HOMEOPATICOS SA DE CVd1407fcf-ae2e-4dac-95bf-6a5f0b21f3a62025-12-11WarningsExact identifier
ndc (product): 34666-001
Arnica Montana NartexARNICA MONTANA, HAMAMELIS VIRGINIANANARTEX LABORATORIOS HOMEOPATICOS SA DE CVd63b84e1-24c1-6c6c-e053-2995a90a22ce2022-01-23WarningsExact identifier
ndc (package): 34666-001-30
ndc (product): 34666-001
ndc11 (package): 34666000130
Arnica Montana NartexARNICA MONTANA, HAMAMELIS VIRGINIANANARTEX LABORATORIOS HOMEOPATICOS SA DE CVcd114ace-c040-9e1b-e053-2a95a90a418b2021-12-29WarningsExact identifier
ndc (product): 34666-001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
34666-001-30346660001301 TUBE in 1 CARTON (34666-001-30) / 74 g in 1 TUBE1 tube2022-01-210000-00-00NoNoCurrent