Ledum Combination

Product NDC
63083-9257
11-digit product format
630839257
Labeler code
63083
Product ID
63083-9257_d444afc7-9686-4d89-888d-a9c48c9192bf
Type
HUMAN OTC DRUG
Nonproprietary name
Ledum Combination
Dosage form
LIQUID
Route
ORAL
Labeler
Professional Complementary Health Formulas
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1984-08-15
Substance
AMMONIUM CATION; ANHYDROUS DIBASIC CALCIUM PHOSPHATE; BERBERIS VULGARIS ROOT BARK; BLACK COHOSH; BOS TAURUS BONE MARROW; BOS TAURUS INTERVERTEBRAL DISC; BOVINE TYPE II COLLAGEN (TRACHEAL CARTILAGE); CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CLAVICEPS PURPUREA SCLEROTIUM; CUPRIC ACETATE; GONORRHEAL URETHRAL SECRETION HUMAN; HORSE CHESTNUT; MERCURIC OXIDE; PICRIC ACID; POTASSIUM CARBONATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE; PULSATILLA MONTANA WHOLE; RANUNCULUS BULBOSUS WHOLE; RHODODENDRON TOMENTOSUM LEAFY TWIG; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SILVER; SODIUM BORATE; SULFUR; SUS SCROFA ADRENAL GLAND; ZINC
Active strength
8; 10; 4; 4; 8; 8; 8; 4; 6; 6; 6; 12; 6; 10; 6; 6; 3; 6; 4; 4; 10; 6; 10; 6; 30; 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; [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; [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
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 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63083-9257-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63083-9257-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63083-9257-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63083-9257-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63083-9257-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63083-9257-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63083-9257-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63083-9257-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63083-9257-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63083-9257-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63083-9257-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63083-9257-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage63083-9257-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63083-9257-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63083-9257-11332a3947898…d4bfe170f9cd…

Additional Listing Data#

Finished product
Yes
Brand name base
Ledum Combination
Brand name suffix
9257
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE8 [hp_X]/29.5mL
BERBERIS VULGARIS ROOT BARK10 [hp_X]/29.5mL
BLACK COHOSH4 [hp_X]/29.5mL
CINCHONA OFFICINALIS BARK4 [hp_X]/29.5mL
RHODODENDRON TOMENTOSUM LEAFY TWIG8 [hp_X]/29.5mL
RANUNCULUS BULBOSUS WHOLE8 [hp_X]/29.5mL
HORSE CHESTNUT8 [hp_X]/29.5mL
SODIUM BORATE4 [hp_X]/29.5mL
CITRULLUS COLOCYNTHIS FRUIT PULP6 [hp_X]/29.5mL
CUPRIC ACETATE6 [hp_X]/29.5mL
POTASSIUM CARBONATE6 [hp_X]/29.5mL
PICRIC ACID12 [hp_X]/29.5mL
PULSATILLA MONTANA WHOLE6 [hp_X]/29.5mL
CLAVICEPS PURPUREA SCLEROTIUM10 [hp_X]/29.5mL
SILICON DIOXIDE6 [hp_X]/29.5mL
AMMONIUM CATION6 [hp_X]/29.5mL
BOS TAURUS BONE MARROW3 [hp_X]/29.5mL
BOVINE TYPE II COLLAGEN (TRACHEAL CARTILAGE)6 [hp_X]/29.5mL
BOS TAURUS INTERVERTEBRAL DISC4 [hp_X]/29.5mL
SUS SCROFA ADRENAL GLAND4 [hp_X]/29.5mL
SILVER10 [hp_X]/29.5mL
ANHYDROUS DIBASIC CALCIUM PHOSPHATE6 [hp_X]/29.5mL
MERCURIC OXIDE10 [hp_X]/29.5mL
SEPIA OFFICINALIS JUICE6 [hp_X]/29.5mL
ZINC30 [hp_X]/29.5mL
GONORRHEAL URETHRAL SECRETION HUMAN10 [hp_X]/29.5mL
SULFUR10 [hp_X]/29.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 27 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
36XQ854NWWInternal UNII lookup
1TH8Q20J0UInternal UNII lookup
K73E24S6X9Internal UNII lookup
S003A158SBInternal UNII lookup
877L01IZ0PInternal UNII lookup
AEQ8NXJ0MBInternal UNII lookup
3C18L6RJAZInternal UNII lookup
91MBZ8H3QOInternal UNII lookup
23H32AOH17Internal UNII lookup
39M11XPH03Internal UNII lookup
BQN1B9B9HAInternal UNII lookup
A49OS0F91SInternal UNII lookup
24K790T39BInternal UNII lookup
01G9XEA93NInternal UNII lookup
ETJ7Z6XBU4Internal UNII lookup
54S68520I4Internal UNII lookup
08X0K2M57PInternal UNII lookup
76TK29UQEZInternal UNII lookup
0A04Z76C13Internal UNII lookup
398IYQ16YVInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
38b89b32-4915-487d-8b2d-250123487b15Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2026-01-09R257
2026-01-09R257
2024-01-30R257
2024-01-30R257

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-9257-1Ledum Combination925729.5 mL in 1 BOTTLE, DROPPERLIQUID29.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63083-9257LEDUM COMBINATION 9257 (LEDUM COMBINATION) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS]1Current NDC, Legacy NDC, 1 package rows20220210_38b89b32-4915-487d-8b2d-250123487b15.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
Ledum Combination 9257LEDUM COMBINATIONProfessional Complementary Health Formulas38b89b32-4915-487d-8b2d-250123487b152026-01-08WarningsExact identifier
ndc (product): 63083-9257

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63083-9257-16308392570129.5 mL in 1 BOTTLE, DROPPER (63083-9257-1) 29.5 ml1985-08-150000-00-00NoNoCurrent