FDA.reportPublic FDA data

Calendula

Product NDC
0220-1105
11-digit product format
002201105
Labeler code
0220
Product ID
0220-1105_11faf72e-0bc6-e598-e063-6394a90a8e06
Type
HUMAN OTC DRUG
Nonproprietary name
CALENDULA OFFICINALIS FLOWERING TOP
Dosage form
GEL
Route
TOPICAL
Labeler
Laboratoires Boiron
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1993-09-30
Substance
CALENDULA OFFICINALIS FLOWERING TOP
Active strength
1 [hp_X]/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
b775b879-6037-44a3-a5bd-045f2d923f3bAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-1105-542023-03-17C16284748780-1f386c649-fed6-0266-e053-dadaa90a7c1aCalendula Gel 1.5oz
0220-1105-542023-01-30C16284748780-1f386c649-fed6-0266-e053-dadaa90a7c1aCalendula Gel 1.5oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-1105-54Calendula45 g in 1 TUBEGEL456

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0220-1105-54GM - Gram0220-11050e7fd89f-22f1-4c64-8e14-cf07ae617b9612021-02-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALENDULA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT18E7415PXQCALENDULA (CALENDULA OFFICINALIS FLOWERING TOP) GEL [LABORATOIRES BOIRON]2
CALENDULA OFFICINALIS FLOWERING TOPACTIVE MOIETY18E7415PXQCALENDULA (CALENDULA OFFICINALIS FLOWERING TOP) GEL [LABORATOIRES BOIRON]2
1,2-HEXANEDIOLINACTIVE INGREDIENTTR046Y3K1GCALENDULA (CALENDULA OFFICINALIS FLOWERING TOP) GEL [LABORATOIRES BOIRON]2
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UCALENDULA (CALENDULA OFFICINALIS FLOWERING TOP) GEL [LABORATOIRES BOIRON]2
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27ECALENDULA (CALENDULA OFFICINALIS FLOWERING TOP) GEL [LABORATOIRES BOIRON]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OCALENDULA (CALENDULA OFFICINALIS FLOWERING TOP) GEL [LABORATOIRES BOIRON]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCALENDULA (CALENDULA OFFICINALIS FLOWERING TOP) GEL [LABORATOIRES BOIRON]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICALENDULA (CALENDULA OFFICINALIS FLOWERING TOP) GEL [LABORATOIRES BOIRON]2
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BCALENDULA (CALENDULA OFFICINALIS FLOWERING TOP) GEL [LABORATOIRES BOIRON]2
WATERINACTIVE INGREDIENT059QF0KO0RCALENDULA (CALENDULA OFFICINALIS FLOWERING TOP) GEL [LABORATOIRES BOIRON]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-1105CALENDULA (CALENDULA OFFICINALIS FLOWERING TOP) GEL [LABORATOIRES BOIRON]6Current NDC, Legacy NDC, 1 package rows20240224_b775b879-6037-44a3-a5bd-045f2d923f3b.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
CalendulaCALENDULA OFFICINALIS FLOWERING TOPLaboratoires Boironb775b879-6037-44a3-a5bd-045f2d923f3b2024-02-22WarningsExact identifier
ndc (product): 0220-1105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0220-1105-540022011055445 g in 1 TUBE (0220-1105-54) 45 g1993-09-300000-00-00NoNoCurrent