CALENDULA OFFICINALIS

Product NDC
15631-0101
Requested package NDC
15631-0101-4
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#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

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

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage15631-010115631-0101-4EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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
CALENDULA OFFICINALISCALENDULA OFFICINALISRxhomeo Private Limited d.b.a. Rxhomeo, Incb9c5accc-5620-4608-9340-54c63cb4f7e12021-09-28WarningsExact identifier
ndc (package): 15631-0101-4
ndc (product): 15631-0101
ndc11 (package): 15631010104

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
15631-0101-4156310101042500 PELLET in 1 PACKAGE (15631-0101-4) 2500 pellet2018-01-010000-00-00NoNoCurrent