Homeopathic Periodontal Gum Relief Formula

Product NDC
10578-046
11-digit product format
105780046
Labeler code
10578
Product ID
10578-046_78652264-87c0-454e-ad13-2c321a04e6c1
Type
HUMAN OTC DRUG
Nonproprietary name
Belladonna, Sodium borate, Hepar sulphuris calcareum, Nitricum acidum
Dosage form
TABLET
Route
ORAL
Labeler
Indiana Botanic Gardens
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2009-04-01
Marketing end
0000-00-00
Substance
ATROPA BELLADONNA; SODIUM BORATE; CALCIUM SULFIDE; NITRIC ACID
Active strength
30 [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 productproduct10578-046DDiscontinued by firm2026-10-05
excluded packagepackage10578-04610578-046-90DDiscontinued by firm2026-10-05

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 NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage10578-046-90DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10578-046-90DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10578-046-90DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10578-046-90DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10578-046-90DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10578-046-90DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10578-046-90DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10578-046-90DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10578-046-90DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10578-046-90DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10578-046-90DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10578-046-90DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage10578-046-90IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage10578-046-90IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductIInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage10578-046-90IInactivated by FDA110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10578-046-902021-01-22C16284748780-1960f7f55-ce75-8e05-e053-dbdaa90a074aHomeopathic Periodontal Gum Relief Formula
10578-046-902019-10-29C16284748780-1960f7f55-ce75-8e05-e053-dbdaa90a074aHomeopathic Periodontal Gum Relief Formula

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0HHOMEOPATHIC PERIODONTAL GUM RELIEF FORMULA (BELLADONNA, SODIUM BORATE, HEPAR SULPHURIS CALCAREUM, NITRICUM ACIDUM) TABLET [INDIANA BOTANIC GARDENS]2
CALCIUM SULFIDEACTIVE INGREDIENT1MBW07J51QHOMEOPATHIC PERIODONTAL GUM RELIEF FORMULA (BELLADONNA, SODIUM BORATE, HEPAR SULPHURIS CALCAREUM, NITRICUM ACIDUM) TABLET [INDIANA BOTANIC GARDENS]2
NITRIC ACIDACTIVE INGREDIENT411VRN1TV4HOMEOPATHIC PERIODONTAL GUM RELIEF FORMULA (BELLADONNA, SODIUM BORATE, HEPAR SULPHURIS CALCAREUM, NITRICUM ACIDUM) TABLET [INDIANA BOTANIC GARDENS]2
SODIUM BORATEACTIVE INGREDIENT91MBZ8H3QOHOMEOPATHIC PERIODONTAL GUM RELIEF FORMULA (BELLADONNA, SODIUM BORATE, HEPAR SULPHURIS CALCAREUM, NITRICUM ACIDUM) TABLET [INDIANA BOTANIC GARDENS]2
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0HHOMEOPATHIC PERIODONTAL GUM RELIEF FORMULA (BELLADONNA, SODIUM BORATE, HEPAR SULPHURIS CALCAREUM, NITRICUM ACIDUM) TABLET [INDIANA BOTANIC GARDENS]2
BORATE IONACTIVE MOIETY44OAE30D22HOMEOPATHIC PERIODONTAL GUM RELIEF FORMULA (BELLADONNA, SODIUM BORATE, HEPAR SULPHURIS CALCAREUM, NITRICUM ACIDUM) TABLET [INDIANA BOTANIC GARDENS]2
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBHOMEOPATHIC PERIODONTAL GUM RELIEF FORMULA (BELLADONNA, SODIUM BORATE, HEPAR SULPHURIS CALCAREUM, NITRICUM ACIDUM) TABLET [INDIANA BOTANIC GARDENS]2
NITRIC ACIDACTIVE MOIETY411VRN1TV4HOMEOPATHIC PERIODONTAL GUM RELIEF FORMULA (BELLADONNA, SODIUM BORATE, HEPAR SULPHURIS CALCAREUM, NITRICUM ACIDUM) TABLET [INDIANA BOTANIC GARDENS]2
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2HOMEOPATHIC PERIODONTAL GUM RELIEF FORMULA (BELLADONNA, SODIUM BORATE, HEPAR SULPHURIS CALCAREUM, NITRICUM ACIDUM) TABLET [INDIANA BOTANIC GARDENS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HOMEOPATHIC PERIODONTAL GUM RELIEF FORMULA (BELLADONNA, SODIUM BORATE, HEPAR SULPHURIS CALCAREUM, NITRICUM ACIDUM) TABLET [INDIANA BOTANIC GARDENS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HOMEOPATHIC PERIODONTAL GUM RELIEF FORMULA (BELLADONNA, SODIUM BORATE, HEPAR SULPHURIS CALCAREUM, NITRICUM ACIDUM) TABLET [INDIANA BOTANIC GARDENS]2