FDA.reportPublic FDA data

Arniflora

Product NDC
53499-5090
11-digit product format
534995090
Labeler code
53499
Product ID
53499-5090_62116d15-5876-4b4e-9d0b-c48b6a28fd71
Type
HUMAN OTC DRUG
Nonproprietary name
ARNICA MONTANA
Dosage form
GEL
Route
TOPICAL
Labeler
Schwabe North America, Inc
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 packagepackage53499-509053499-5090-4DDiscontinued by firm2026-08-17

Additional Listing Data#

Finished product
Yes
Brand name base
Arniflora
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
935bf19d-a32c-49b8-a5cc-13e7ddfb23feAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-5090-4Arniflora28 g in 1 TUBEGEL2815
53499-5090-4Arniflora1 in 1 CARTONGEL115
53499-5090-8Arniflora78 g in 1 TUBEGEL7815
53499-5090-8Arniflora1 in 1 CARTONGEL115

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZWARNIFLORA (ARNICA MONTANA) GEL [NATURE'S WAY PRODUCTS, INC.]4
ARNICA MONTANAACTIVE MOIETYO80TY208ZWARNIFLORA (ARNICA MONTANA) GEL [NATURE'S WAY PRODUCTS, INC.]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MARNIFLORA (ARNICA MONTANA) GEL [NATURE'S WAY PRODUCTS, INC.]4
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27EARNIFLORA (ARNICA MONTANA) GEL [NATURE'S WAY PRODUCTS, INC.]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IARNIFLORA (ARNICA MONTANA) GEL [NATURE'S WAY PRODUCTS, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RARNIFLORA (ARNICA MONTANA) GEL [NATURE'S WAY PRODUCTS, INC.]4
WITCH HAZELINACTIVE INGREDIENT101I4J0U34ARNIFLORA (ARNICA MONTANA) GEL [NATURE'S WAY PRODUCTS, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-5090ARNIFLORA (ARNICA MONTANA) GEL [SCHWABE NORTH AMERICA, INC]14Current NDC, Legacy NDC, 4 package rows20241206_935bf19d-a32c-49b8-a5cc-13e7ddfb23fe.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
ArnifloraARNICA MONTANASchwabe North America, Inc935bf19d-a32c-49b8-a5cc-13e7ddfb23fe2025-11-21WarningsExact identifier
ndc (product): 53499-5090

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53499-5090-4534995090041 TUBE in 1 CARTON (53499-5090-4) / 28 g in 1 TUBE1 tube2011-01-012026-05-31NoNoCurrent
53499-5090-8534995090081 TUBE in 1 CARTON (53499-5090-8) / 78 g in 1 TUBE1 tube2011-01-010000-00-00NoNoCurrent