Home NDC 63083-9228-1 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 FERULA ASSA-FOETIDA RESIN; KALMIA LATIFOLIA LEAF; CAUSTICUM; COLCHICUM AUTUMNALE BULB; IRON; PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE; LITHIUM BENZOATE; MERCURIC OXIDE; TOXICODENDRON PUBESCENS LEAF; FILIPENDULA ULMARIA ROOT
Active strength 8; 8; 10; 10; 10; 10; 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 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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 Ingredient Strength FERULA ASSA-FOETIDA RESIN 8 [hp_X]/29.5mL KALMIA LATIFOLIA LEAF 8 [hp_X]/29.5mL CAUSTICUM 10 [hp_X]/29.5mL COLCHICUM AUTUMNALE BULB 10 [hp_X]/29.5mL IRON 10 [hp_X]/29.5mL PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE 10 [hp_X]/29.5mL LITHIUM BENZOATE 10 [hp_X]/29.5mL MERCURIC OXIDE 10 [hp_X]/29.5mL TOXICODENDRON PUBESCENS LEAF 10 [hp_X]/29.5mL FILIPENDULA ULMARIA ROOT 10 [hp_X]/29.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 10 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# Effective, Related label table Effective Related label 2026-01-09 R228 2026-01-09 R228 2024-01-30 R228 2024-01-30 R228
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63083-9228-1 Kalmia Combination9228 29.5 mL in 1 BOTTLE, DROPPER LIQUID 29.5 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63083-9228 KALMIA COMBINATION 9228 (KALMIA COMBINATION) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS] 1 Current NDC, Legacy NDC, 1 package rows 20220210_20e739b4-8b7c-4dd9-876d-99156ea47209.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63083-9228-1 63083922801 29.5 mL in 1 BOTTLE, DROPPER (63083-9228-1) 29.5 ml 1985-08-15 0000-00-00 No No Current