FDA.reportPublic FDA data

Calendula

Product NDC
0220-1105
Requested package NDC
0220-1105-54
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 (package): 0220-1105-54
ndc (product): 0220-1105
ndc11 (package): 00220110554

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

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