FDA.reportPublic FDA data

Arniflora Gel

Product NDC
68466-0004
11-digit product format
684660004
Labeler code
68466
Product ID
68466-0004_11f1a77b-71cd-41fb-945f-6d7d1d9b12e2
Type
HUMAN OTC DRUG
Nonproprietary name
ARNICA MONTANA
Dosage form
GEL
Route
TOPICAL; TOPICAL
Labeler
Schwabe Mexico S.A. de C.V.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2011-01-01
Substance
ARNICA MONTANA
Active strength
1 [hp_X]/28g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68466-000468466-0004-4DDiscontinued by firm2026-08-11

Additional Listing Data#

Finished product
Yes
Brand name base
Arniflora Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARNICA MONTANA1 [hp_X]/28g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2031b9b0-a188-43c9-95da-6488a3ba033dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68466-0004-4Arniflora Gel28 g in 1 TUBEGEL2810
68466-0004-4Arniflora Gel1 in 1 CARTONGEL110
68466-0004-8Arniflora Gel1 in 1 CARTONGEL110
68466-0004-8Arniflora Gel78 g in 1 TUBEGEL7810

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68466-0004ARNIFLORA GEL (ARNICA MONTANA) GEL [SCHWABE MEXICO S.A. DE C.V.]9Current NDC, Legacy NDC, 4 package rows20241206_2031b9b0-a188-43c9-95da-6488a3ba033d.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arniflora GelARNICA MONTANASchwabe Mexico S.A. de C.V.2031b9b0-a188-43c9-95da-6488a3ba033d2025-11-21WarningsExact identifier
ndc (product): 68466-0004

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68466-0004-4684660004041 TUBE in 1 CARTON (68466-0004-4) / 28 g in 1 TUBE1 tube2011-01-012026-05-31NoNoCurrent
68466-0004-8684660004081 TUBE in 1 CARTON (68466-0004-8) / 78 g in 1 TUBE1 tube2011-01-010000-00-00NoNoCurrent