FDA.reportPublic FDA data

Arnica Calendula Special Order

Manufacturer
Uriel Pharmacy Inc.
Effective date
2014-09-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:06:06

Label at a glance#

ProductArnica Calendula Special Order
Active ingredientARNICA MONTANA FLOWER, CALENDULA OFFICINALIS FLOWERING TOP, ECHINACEA ANGUSTIFOLIA, COLLOIDAL SILICON DIOXIDE, ANTIMONY
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR ORAL USE ONLY.

DOSAGE & ADMINISTRATION SECTION

Take 3-4 times daily. Ages 12 and older: 1/8 teaspoon. Ages 2-11: 1/16 teaspoon. Under age 2: Consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: 100gm contains: 2.5gm Arnica e flor. 1X, 1.65gm Calendula ex herba 1X, 1.65 Echinacea ex herba 1X, 0.1gm Quartz 1X, 0.1gm Stibium 1X

INACTIVE INGREDIENT SECTION

Inactive Ingredient: Diatomaceous earth

OTC - PURPOSE SECTION

Use: Temporary relief of minor bruises, cuts and scrapes.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

Warnings: Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRODUCT LABELPRODUCT LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
48951-1248-42020-01-31C16284748780-19d75b9d1-14eb-f424-e053-dadaa90a57ceArnica Calendula Special Order

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-1248-4Arnica Calendula Special Order20 g in 1 BOTTLE, GLASSPOWDER201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-1248ARNICA CALENDULA SPECIAL ORDER POWDER [URIEL PHARMACY INC.]1Legacy NDC, 1 package rows20141030_15e0684a-2df9-4ece-9d9e-938fcce12eb6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ANTIMONYACTIVE INGREDIENT9IT35J3UV31
ARNICA MONTANA FLOWERACTIVE INGREDIENTOZ0E5Y15PZ1
CALENDULA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT18E7415PXQ1
COLLOIDAL SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU41
ECHINACEA ANGUSTIFOLIAACTIVE INGREDIENTVB06AV5US81
ANTIMONYACTIVE MOIETY9IT35J3UV31
ARNICA MONTANA FLOWERACTIVE MOIETYOZ0E5Y15PZ1
CALENDULA OFFICINALIS FLOWERING TOPACTIVE MOIETY18E7415PXQ1
COLLOIDAL SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU41
ECHINACEA ANGUSTIFOLIAACTIVE MOIETYVB06AV5US81
DIATOMACEOUS EARTHINACTIVE INGREDIENT2RF6EJ0M851

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-124848951-1248-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANA FLOWEROZ0E5Y15PZACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
COLLOIDAL SILICON DIOXIDEETJ7Z6XBU4ACTIB
ANTIMONY9IT35J3UV3ACTIB
DIATOMACEOUS EARTH2RF6EJ0M85IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 10 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
DIATOMACEOUS EARTHDIATOMACEOUS EARTH2RF6EJ0M85TABLET, EXTENDED RELEASE / ORAL5 mgExact identifier — unii candidate
10 equally ranked IID candidates
DIATOMACEOUS EARTHDIATOMACEOUS EARTH2RF6EJ0M85CAPSULE / ORAL3.4 mgExact identifier — unii candidate
10 equally ranked IID candidates
DIATOMACEOUS EARTHDIATOMACEOUS EARTH2RF6EJ0M85TABLET / ORAL88 mgExact identifier — unii candidate
10 equally ranked IID candidates
DIATOMACEOUS EARTHDIATOMACEOUS EARTH2RF6EJ0M85TABLET, COATED / ORAL7.2 mgExact identifier — unii candidate
10 equally ranked IID candidates
DIATOMACEOUS EARTHDIATOMACEOUS EARTH2RF6EJ0M85ELIXIR / ORALNAExact identifier — unii candidate
10 equally ranked IID candidates
DIATOMACEOUS EARTHDIATOMACEOUS EARTH2RF6EJ0M85CONCENTRATE / ORALNAExact identifier — unii candidate
10 equally ranked IID candidates
DIATOMACEOUS EARTHDIATOMACEOUS EARTH2RF6EJ0M85CAPSULE, EXTENDED RELEASE / ORAL5 mgExact identifier — unii candidate
10 equally ranked IID candidates
DIATOMACEOUS EARTHDIATOMACEOUS EARTH2RF6EJ0M85SYRUP / ORALNAExact identifier — unii candidate
10 equally ranked IID candidates
DIATOMACEOUS EARTHDIATOMACEOUS EARTH2RF6EJ0M85SOAP / TOPICAL0.27 %w/wExact identifier — unii candidate
10 equally ranked IID candidates
DIATOMACEOUS EARTHDIATOMACEOUS EARTH2RF6EJ0M85TABLET, CHEWABLE / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates

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
1d9aea5d-d995-4d1a-83bf-83dbb09291ce15e0684a-2df9-4ece-9d9e-938fcce12eb62014-09-29WarningsExact identifier
spl id: 1d9aea5d-d995-4d1a-83bf-83dbb09291ce
spl set id: 15e0684a-2df9-4ece-9d9e-938fcce12eb6

Reported adverse events (FAERS/openFDA)#

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