FDA.reportPublic FDA data

ProSirona

Manufacturer
Atlantic Management Resources Inc.
Effective date
2022-07-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:17:43

Label at a glance#

ProductProSirona
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active IngredientsActive Ingredients

WARNINGS SECTION

WarningsWarnings

INACTIVE INGREDIENT SECTION

Inactive IngredientsInactive Ingredients

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of ChildrenKeep out of reach of Children

OTC - PURPOSE SECTION

OTC Purpose SectionOTC Purpose Section

DOSAGE & ADMINISTRATION SECTION

Dosage and AdmiinistrationDosage and Admiinistration

INDICATIONS & USAGE SECTION

Indications and UsageIndications and Usage

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ProSirona LabelProSirona Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66233-713-012024-01-30C16284748780-1d6a99b39-6d37-a426-e053-dadaa90af4c2ProSirona
66233-713-012022-07-11C16284748780-1d6a99b39-6d37-a426-e053-dadaa90af4c2ProSirona
66233-713-012022-01-28C16284748780-1d6a99b39-6d37-a426-e053-dadaa90af4c2ProSirona

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66233-713-01ProSirona1 g in 1 BOTTLE, WITH APPLICATOROIL14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66233-713PROSIRONA (CALENDULA OFICINALIS FLOWERING TOP) OIL [ATLANTIC MANAGEMENT RESOURCES INC.]4Legacy NDC, 1 package rows20220713_2b1fdab7-12e5-1ecd-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66233-71366233-713-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR OIL, WHITE26P3H26Z9XIACT
CORIANDER OIL7626GC95E5IACT
ROSEMARY OIL8LGU7VM393IACT
MINERAL OILT5L8T28FGPIACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
PENNYROYAL OILAK85U7Y3MVIACT
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
ORANGE OILAKN3KSD11BIACT
ALMOND OIL66YXD4DKO9IACT

Source Document#

Source XML

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
e38c79a0-6963-12fb-e053-2a95a90a99082b1fdab7-12e5-1ecd-e054-00144ff8d46c2022-07-11WarningsExact identifier
spl id: e38c79a0-6963-12fb-e053-2a95a90a9908
spl set id: 2b1fdab7-12e5-1ecd-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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