CALENDULA OFFICINALIS

Product NDC
15631-0101
Requested package NDC
15631-0101-2
11-digit product format
156310101
Labeler code
15631
Product ID
15631-0101_cd1303d5-e3db-c53c-e053-2995a90a5c50
Type
HUMAN OTC DRUG
Nonproprietary name
CALENDULA OFFICINALIS
Dosage form
PELLET
Route
ORAL
Labeler
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-10-02
Substance
CALENDULA OFFICINALIS FLOWERING TOP
Active strength
1 [hp_X]/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage15631-010115631-0101-2EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]/1

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
b9c5accc-5620-4608-9340-54c63cb4f7e1Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15631-0101-0CALENDULA OFFICINALIS100 in 1 PACKAGEPELLET1003
15631-0101-1CALENDULA OFFICINALIS200 in 1 PACKAGEPELLET2003
15631-0101-2CALENDULA OFFICINALIS400 in 1 PACKAGEPELLET4003
15631-0101-3CALENDULA OFFICINALIS750 in 1 PACKAGEPELLET7503
15631-0101-4CALENDULA OFFICINALIS2500 in 1 PACKAGEPELLET25003
15631-0101-5CALENDULA OFFICINALIS12500 in 1 PACKAGEPELLET125003
15631-0101-6CALENDULA OFFICINALIS500 in 1 PACKAGEPELLET5003
15631-0101-7CALENDULA OFFICINALIS1000 in 1 PACKAGEPELLET10003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALENDULA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT18E7415PXQCALENDULA OFFICINALIS PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]1
CALENDULA OFFICINALIS FLOWERING TOPACTIVE MOIETY18E7415PXQCALENDULA OFFICINALIS PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]1
SUCROSEINACTIVE INGREDIENTC151H8M554CALENDULA OFFICINALIS PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15631-0101CALENDULA OFFICINALIS PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]3Current NDC, Legacy NDC, 8 package rows20210929_b9c5accc-5620-4608-9340-54c63cb4f7e1.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 OFFICINALISCALENDULA OFFICINALISRxhomeo Private Limited d.b.a. Rxhomeo, Incb9c5accc-5620-4608-9340-54c63cb4f7e12021-09-28WarningsExact identifier
ndc (package): 15631-0101-2
ndc (product): 15631-0101
ndc11 (package): 15631010102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
15631-0101-215631010102400 PELLET in 1 PACKAGE (15631-0101-2) 400 pellet2018-01-010000-00-00NoNoCurrent