Homeopathic Cold and Canker Sore Formula

Product NDC
10578-052
11-digit product format
105780052
Labeler code
10578
Product ID
10578-052_aacb3393-ee2d-475c-925f-79a9fa2c015e
Type
HUMAN OTC DRUG
Nonproprietary name
Antimonum crudum, Apis mellifica, Cuprum metallicum, Euphorbia lathyris, Rhus toxicodendron
Dosage form
TABLET
Route
ORAL
Labeler
Indiana Botanic Gardens
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2010-07-07
Marketing end
0000-00-00
Substance
ANTIMONY TRISULFIDE; APIS MELLIFERA; COPPER; EUPHORBIA LATHYRIS; TOXICODENDRON PUBESCENS LEAF
Active strength
10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct10578-052DDiscontinued by firm2026-10-12
excluded packagepackage10578-05210578-052-90DDiscontinued by firm2026-10-12

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 · 44 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 packagepackage10578-052-90d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10578-052-90f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10578-052-902ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10578-052-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10578-052-90cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10578-052-90cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10578-052-90302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10578-052-90ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10578-052-900efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10578-052-90ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10578-052-90367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10578-052-90557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage10578-052-908af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage10578-052-90834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage10578-052-901332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage10578-052-90fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage10578-052-9086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage10578-052-90bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage10578-052-908dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage10578-052-90e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage10578-052-909bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage10578-052-90110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10578-052-902019-10-29C16284748780-1960f7f55-d0e2-8e05-e053-dbdaa90a074aHomeopathic Cold and Canker Sore Formula

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10578-052-90Homeopathic Cold and Canker Sore Formula90 in 1 BOTTLETABLET902

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANTIMONY TRISULFIDEACTIVE INGREDIENTF79059A38UHOMEOPATHIC COLD AND CANKER SORE FORMULA (ANTIMONUM CRUDUM, APIS MELLIFICA, CUPRUM METALLICUM, EUPHORBIA LATHYRIS, RHUS TOXICODENDRON) TABLET [INDIANA BOTANIC GARDENS]2
APIS MELLIFERAACTIVE INGREDIENT7S82P3R43ZHOMEOPATHIC COLD AND CANKER SORE FORMULA (ANTIMONUM CRUDUM, APIS MELLIFICA, CUPRUM METALLICUM, EUPHORBIA LATHYRIS, RHUS TOXICODENDRON) TABLET [INDIANA BOTANIC GARDENS]2
COPPERACTIVE INGREDIENT789U1901C5HOMEOPATHIC COLD AND CANKER SORE FORMULA (ANTIMONUM CRUDUM, APIS MELLIFICA, CUPRUM METALLICUM, EUPHORBIA LATHYRIS, RHUS TOXICODENDRON) TABLET [INDIANA BOTANIC GARDENS]2
EUPHORBIA LATHYRISACTIVE INGREDIENTGHV7FV90K2HOMEOPATHIC COLD AND CANKER SORE FORMULA (ANTIMONUM CRUDUM, APIS MELLIFICA, CUPRUM METALLICUM, EUPHORBIA LATHYRIS, RHUS TOXICODENDRON) TABLET [INDIANA BOTANIC GARDENS]2
TOXICODENDRON PUBESCENS LEAFACTIVE INGREDIENT6IO182RP7AHOMEOPATHIC COLD AND CANKER SORE FORMULA (ANTIMONUM CRUDUM, APIS MELLIFICA, CUPRUM METALLICUM, EUPHORBIA LATHYRIS, RHUS TOXICODENDRON) TABLET [INDIANA BOTANIC GARDENS]2
ANTIMONY CATION (3+)ACTIVE MOIETY069647RPT5HOMEOPATHIC COLD AND CANKER SORE FORMULA (ANTIMONUM CRUDUM, APIS MELLIFICA, CUPRUM METALLICUM, EUPHORBIA LATHYRIS, RHUS TOXICODENDRON) TABLET [INDIANA BOTANIC GARDENS]2
APIS MELLIFERAACTIVE MOIETY7S82P3R43ZHOMEOPATHIC COLD AND CANKER SORE FORMULA (ANTIMONUM CRUDUM, APIS MELLIFICA, CUPRUM METALLICUM, EUPHORBIA LATHYRIS, RHUS TOXICODENDRON) TABLET [INDIANA BOTANIC GARDENS]2
COPPERACTIVE MOIETY789U1901C5HOMEOPATHIC COLD AND CANKER SORE FORMULA (ANTIMONUM CRUDUM, APIS MELLIFICA, CUPRUM METALLICUM, EUPHORBIA LATHYRIS, RHUS TOXICODENDRON) TABLET [INDIANA BOTANIC GARDENS]2
EUPHORBIA LATHYRISACTIVE MOIETYGHV7FV90K2HOMEOPATHIC COLD AND CANKER SORE FORMULA (ANTIMONUM CRUDUM, APIS MELLIFICA, CUPRUM METALLICUM, EUPHORBIA LATHYRIS, RHUS TOXICODENDRON) TABLET [INDIANA BOTANIC GARDENS]2
TOXICODENDRON PUBESCENS LEAFACTIVE MOIETY6IO182RP7AHOMEOPATHIC COLD AND CANKER SORE FORMULA (ANTIMONUM CRUDUM, APIS MELLIFICA, CUPRUM METALLICUM, EUPHORBIA LATHYRIS, RHUS TOXICODENDRON) TABLET [INDIANA BOTANIC GARDENS]2
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2HOMEOPATHIC COLD AND CANKER SORE FORMULA (ANTIMONUM CRUDUM, APIS MELLIFICA, CUPRUM METALLICUM, EUPHORBIA LATHYRIS, RHUS TOXICODENDRON) TABLET [INDIANA BOTANIC GARDENS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HOMEOPATHIC COLD AND CANKER SORE FORMULA (ANTIMONUM CRUDUM, APIS MELLIFICA, CUPRUM METALLICUM, EUPHORBIA LATHYRIS, RHUS TOXICODENDRON) TABLET [INDIANA BOTANIC GARDENS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HOMEOPATHIC COLD AND CANKER SORE FORMULA (ANTIMONUM CRUDUM, APIS MELLIFICA, CUPRUM METALLICUM, EUPHORBIA LATHYRIS, RHUS TOXICODENDRON) TABLET [INDIANA BOTANIC GARDENS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10578-052HOMEOPATHIC COLD AND CANKER SORE FORMULA (ANTIMONUM CRUDUM, APIS MELLIFICA, CUPRUM METALLICUM, EUPHORBIA LATHYRIS, RHUS TOXICODENDRON) TABLET [INDIANA BOTANIC GARDENS]2Legacy NDC, 1 package rows20110627_ed169621-d986-4d6c-bb67-a91eb5880788.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10578-052-901057800529090 in 1 BOTTLEHistorical