FDA.reportPublic FDA data

Kalmia Combination

Product NDC
63083-9228
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

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
CAUSTICUM10 [hp_X]/29.5mL
COLCHICUM AUTUMNALE BULB10 [hp_X]/29.5mL
FERULA ASSA-FOETIDA RESIN8 [hp_X]/29.5mL
FILIPENDULA ULMARIA ROOT10 [hp_X]/29.5mL
IRON10 [hp_X]/29.5mL
KALMIA LATIFOLIA LEAF8 [hp_X]/29.5mL
LITHIUM BENZOATE10 [hp_X]/29.5mL
MERCURIC OXIDE10 [hp_X]/29.5mL
PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE10 [hp_X]/29.5mL
TOXICODENDRON PUBESCENS LEAF10 [hp_X]/29.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDD5FO1WKFU, 993QHL78E6, W9FZA51AS1, 997724QNDS, E1UOL152H7, 79N6542N18, R9Z042Z19E, IY191986AO, 36XQ854NWW, 6IO182RP7A

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