KALMIA LATIFOLIA

Product NDC
15631-0255
Requested package NDC
15631-0255-4
11-digit product format
156310255
Labeler code
15631
Product ID
15631-0255_ce16ed47-6b24-5ea8-e053-2995a90ad1b2
Type
HUMAN OTC DRUG
Nonproprietary name
KALMIA LATIFOLIA
Dosage form
PELLET
Route
ORAL
Labeler
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-09-05
Substance
KALMIA LATIFOLIA LEAF
Active strength
3 [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 packagepackage15631-025515631-0255-4EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KALMIA LATIFOLIA LEAF3 [hp_X]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
79N6542N18Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
91042d4d-dc32-4a02-8203-fda0f5ef1c15Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15631-0255-0KALMIA LATIFOLIA100 in 1 PACKAGEPELLET1004
15631-0255-1KALMIA LATIFOLIA200 in 1 PACKAGEPELLET2004
15631-0255-2KALMIA LATIFOLIA400 in 1 PACKAGEPELLET4004
15631-0255-3KALMIA LATIFOLIA750 in 1 PACKAGEPELLET7504
15631-0255-4KALMIA LATIFOLIA2500 in 1 PACKAGEPELLET25004
15631-0255-5KALMIA LATIFOLIA12500 in 1 PACKAGEPELLET125004
15631-0255-6KALMIA LATIFOLIA500 in 1 PACKAGEPELLET5004
15631-0255-7KALMIA LATIFOLIA1000 in 1 PACKAGEPELLET10004

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KALMIA LATIFOLIA LEAFACTIVE INGREDIENT79N6542N18KALMIA LATIFOLIA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]2
KALMIA LATIFOLIA LEAFACTIVE MOIETY79N6542N18KALMIA LATIFOLIA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]2
SUCROSEINACTIVE INGREDIENTC151H8M554KALMIA LATIFOLIA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15631-0255KALMIA LATIFOLIA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]4Current NDC, Legacy NDC, 8 package rows20211012_91042d4d-dc32-4a02-8203-fda0f5ef1c15.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
KALMIA LATIFOLIAKALMIA LATIFOLIARxhomeo Private Limited d.b.a. Rxhomeo, Inc91042d4d-dc32-4a02-8203-fda0f5ef1c152021-10-11WarningsExact identifier
ndc (package): 15631-0255-4
ndc (product): 15631-0255
ndc11 (package): 15631025504

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
15631-0255-4156310255042500 PELLET in 1 PACKAGE (15631-0255-4) 2500 pellet2018-01-010000-00-00NoNoCurrent