Kalmia Combination

Product NDC
63083-9228
Requested package NDC
63083-9228-1
11-digit product format
630839228
Labeler code
63083
Product ID
63083-9228_855d47cf-4e91-4e91-892b-c1e703cbf8ec
Type
HUMAN OTC DRUG
Nonproprietary name
Kalmia Combination
Dosage form
LIQUID
Route
ORAL
Labeler
Professional Complementary Health Formulas
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1984-08-15
Substance
CAUSTICUM; COLCHICUM AUTUMNALE BULB; FERULA ASSA-FOETIDA RESIN; FILIPENDULA ULMARIA ROOT; IRON; KALMIA LATIFOLIA LEAF; LITHIUM BENZOATE; MERCURIC OXIDE; PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE; TOXICODENDRON PUBESCENS LEAF
Active strength
10; 10; 8; 10; 10; 8; 10; 10; 10; 10 [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL
Pharmacologic classes
Mood Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Kalmia Combination 9228KALMIA COMBINATIONProfessional Complementary Health Formulas20e739b4-8b7c-4dd9-876d-99156ea472092026-01-08WarningsExact identifier
ndc (package): 63083-9228-1
ndc (product): 63083-9228
ndc11 (package): 63083922801

Additional Listing Data#

Finished product
Yes
Brand name base
Kalmia Combination
Brand name suffix
9228
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FERULA ASSA-FOETIDA RESIN10 [hp_X]/29.5mL
KALMIA LATIFOLIA LEAF10 [hp_X]/29.5mL
CAUSTICUM8 [hp_X]/29.5mL
COLCHICUM AUTUMNALE BULB10 [hp_X]/29.5mL
IRON10 [hp_X]/29.5mL
PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE8 [hp_X]/29.5mL
LITHIUM BENZOATE10 [hp_X]/29.5mL
MERCURIC OXIDE10 [hp_X]/29.5mL
TOXICODENDRON PUBESCENS LEAF10 [hp_X]/29.5mL
FILIPENDULA ULMARIA ROOT10 [hp_X]/29.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
W9FZA51AS1Internal UNII lookup
79N6542N18Internal UNII lookup
DD5FO1WKFUInternal UNII lookup
993QHL78E6Internal UNII lookup
E1UOL152H7Internal UNII lookup
36XQ854NWWInternal UNII lookup
R9Z042Z19EInternal UNII lookup
IY191986AOInternal UNII lookup
6IO182RP7AInternal UNII lookup
997724QNDSInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
20e739b4-8b7c-4dd9-876d-99156ea47209Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3053bb1-353b-4a0b-bca5-28fe7228957cProduct name220250124
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808
8ce6e144-236f-b7be-f690-f06e0c8c6bd3Product name220170725
f09af6ee-c6dd-d0ce-77ad-93508bcdacedProduct name420161205

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63083-9228-12026-01-09C16284748780-11030e365-2cca-111a-e063-dadaa90a10e2R228
63083-9228-12026-01-09C16284748780-11030e365-2cca-111a-e063-dadaa90a10e2R228
63083-9228-12024-01-30C16284748780-11030e365-2cca-111a-e063-dadaa90a10e2R228
63083-9228-12024-01-30C16284748780-11030e365-2cca-111a-e063-dadaa90a10e2R228

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-9228-1Kalmia Combination922829.5 mL in 1 BOTTLE, DROPPERLIQUID29.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63083-9228KALMIA COMBINATION 9228 (KALMIA COMBINATION) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS]1Current NDC, Legacy NDC, 1 package rows20220210_20e739b4-8b7c-4dd9-876d-99156ea47209.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63083-9228-16308392280129.5 mL in 1 BOTTLE, DROPPER (63083-9228-1) 29.5 ml1985-08-150000-00-00NoNoCurrent