FDA.reportPublic FDA data

Arnica Cream

Product NDC
62106-1180
11-digit product format
621061180
Labeler code
62106
Product ID
62106-1180_dc794e74-8ef3-7942-e053-2a95a90a2bea
Type
HUMAN OTC DRUG
Nonproprietary name
Arnica montana
Dosage form
CREAM
Route
TOPICAL
Labeler
Seroyal USA
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-01-20
Substance
ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP
Active strength
1; 1 [hp_X]/40g; [hp_X]/40g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Arnica Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARNICA MONTANA1 [hp_X]/40g
CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]/40g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O80TY208ZWInternal UNII lookup
18E7415PXQInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
079c4f1c-836d-1113-e054-00144ff8d46cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62106-1180-0Arnica Cream1 in 1 CARTONCREAM111
62106-1180-0Arnica Cream40 g in 1 TUBECREAM4011

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZWCALENDULA CREAM (CALENDULA OFFICINALIS) CREAM ARNICA CREAM (ARNICA MONTANA) CREAM [SEROYAL USA]5
CALENDULA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT18E7415PXQCALENDULA CREAM (CALENDULA OFFICINALIS) CREAM ARNICA CREAM (ARNICA MONTANA) CREAM [SEROYAL USA]5
ARNICA MONTANAACTIVE MOIETYO80TY208ZWCALENDULA CREAM (CALENDULA OFFICINALIS) CREAM ARNICA CREAM (ARNICA MONTANA) CREAM [SEROYAL USA]5
CALENDULA OFFICINALIS FLOWERING TOPACTIVE MOIETY18E7415PXQCALENDULA CREAM (CALENDULA OFFICINALIS) CREAM ARNICA CREAM (ARNICA MONTANA) CREAM [SEROYAL USA]5
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SCALENDULA CREAM (CALENDULA OFFICINALIS) CREAM ARNICA CREAM (ARNICA MONTANA) CREAM [SEROYAL USA]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCALENDULA CREAM (CALENDULA OFFICINALIS) CREAM ARNICA CREAM (ARNICA MONTANA) CREAM [SEROYAL USA]5
ROSE OILINACTIVE INGREDIENTWUB68Y35M7CALENDULA CREAM (CALENDULA OFFICINALIS) CREAM ARNICA CREAM (ARNICA MONTANA) CREAM [SEROYAL USA]5
WATERINACTIVE INGREDIENT059QF0KO0RCALENDULA CREAM (CALENDULA OFFICINALIS) CREAM ARNICA CREAM (ARNICA MONTANA) CREAM [SEROYAL USA]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62106-1180CALENDULA CREAM (CALENDULA OFFICINALIS) CREAM ARNICA CREAM (ARNICA MONTANA) CREAM [SEROYAL USA]11Current NDC, Legacy NDC, 2 package rows20220413_079c4f1c-836d-1113-e054-00144ff8d46c.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
Calendula CreamCALENDULA OFFICINALISSeroyal USA079c4f1c-836d-1113-e054-00144ff8d46c2022-04-12WarningsExact identifier
ndc (product): 62106-1180

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62106-1180-0621061180001 TUBE in 1 CARTON (62106-1180-0) / 40 g in 1 TUBE1 tube2015-01-200000-00-00NoNoCurrent