Homeopathic Ear Ache Formula

Product NDC
10578-048
11-digit product format
105780048
Labeler code
10578
Product ID
10578-048_59de25fc-e58f-47a8-9bba-58af1626b760
Type
HUMAN OTC DRUG
Nonproprietary name
Aconitum napellus, Belladonna, Capsicum, Chamomile, Ferrum phosphoricum, Kali muriaticum
Dosage form
TABLET
Route
ORAL
Labeler
Indiana Botanic Gardens
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2009-04-01
Marketing end
0000-00-00
Substance
ACONITUM NAPELLUS; ATROPA BELLADONNA; CAPSICUM; CHAMOMILE; FERRUM PHOSPHORICUM; POTASSIUM CHLORIDE
Active strength
30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/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 productproduct10578-048DDiscontinued by firm2026-10-05
excluded packagepackage10578-04810578-048-90DDiscontinued 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 packagepackage10578-048-90DDiscontinued 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 packagepackage10578-048-90DDiscontinued 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 packagepackage10578-048-90DDiscontinued 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 packagepackage10578-048-90DDiscontinued 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 packagepackage10578-048-90DDiscontinued 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 packagepackage10578-048-90DDiscontinued 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 packagepackage10578-048-90DDiscontinued 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 packagepackage10578-048-90DDiscontinued 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 packagepackage10578-048-90DDiscontinued 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 packagepackage10578-048-90DDiscontinued 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 packagepackage10578-048-90DDiscontinued 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 packagepackage10578-048-90DDiscontinued 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 packagepackage10578-048-90IInactivated 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 packagepackage10578-048-90IInactivated 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 packagepackage10578-048-90IInactivated 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
10578-048-902021-01-22C16284748780-1960f7f55-cabe-8e05-e053-dbdaa90a074aHomeopathic Ear Ache Formula
10578-048-902019-10-29C16284748780-1960f7f55-cabe-8e05-e053-dbdaa90a074aHomeopathic Ear Ache Formula

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JDHOMEOPATHIC EAR ACHE FORMULA (ACONITUM NAPELLUS, BELLADONNA, CAPSICUM, CHAMOMILE, FERRUM PHOSPHORICUM, KALI MURIATICUM) TABLET [INDIANA BOTANIC GARDENS]3
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0HHOMEOPATHIC EAR ACHE FORMULA (ACONITUM NAPELLUS, BELLADONNA, CAPSICUM, CHAMOMILE, FERRUM PHOSPHORICUM, KALI MURIATICUM) TABLET [INDIANA BOTANIC GARDENS]3
CAPSICUMACTIVE INGREDIENT00UK7646FGHOMEOPATHIC EAR ACHE FORMULA (ACONITUM NAPELLUS, BELLADONNA, CAPSICUM, CHAMOMILE, FERRUM PHOSPHORICUM, KALI MURIATICUM) TABLET [INDIANA BOTANIC GARDENS]3
CHAMOMILEACTIVE INGREDIENTFGL3685T2XHOMEOPATHIC EAR ACHE FORMULA (ACONITUM NAPELLUS, BELLADONNA, CAPSICUM, CHAMOMILE, FERRUM PHOSPHORICUM, KALI MURIATICUM) TABLET [INDIANA BOTANIC GARDENS]3
FERRUM PHOSPHORICUMACTIVE INGREDIENT91GQH8I5F7HOMEOPATHIC EAR ACHE FORMULA (ACONITUM NAPELLUS, BELLADONNA, CAPSICUM, CHAMOMILE, FERRUM PHOSPHORICUM, KALI MURIATICUM) TABLET [INDIANA BOTANIC GARDENS]3
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I10HOMEOPATHIC EAR ACHE FORMULA (ACONITUM NAPELLUS, BELLADONNA, CAPSICUM, CHAMOMILE, FERRUM PHOSPHORICUM, KALI MURIATICUM) TABLET [INDIANA BOTANIC GARDENS]3
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JDHOMEOPATHIC EAR ACHE FORMULA (ACONITUM NAPELLUS, BELLADONNA, CAPSICUM, CHAMOMILE, FERRUM PHOSPHORICUM, KALI MURIATICUM) TABLET [INDIANA BOTANIC GARDENS]3
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0HHOMEOPATHIC EAR ACHE FORMULA (ACONITUM NAPELLUS, BELLADONNA, CAPSICUM, CHAMOMILE, FERRUM PHOSPHORICUM, KALI MURIATICUM) TABLET [INDIANA BOTANIC GARDENS]3
CAPSICUMACTIVE MOIETY00UK7646FGHOMEOPATHIC EAR ACHE FORMULA (ACONITUM NAPELLUS, BELLADONNA, CAPSICUM, CHAMOMILE, FERRUM PHOSPHORICUM, KALI MURIATICUM) TABLET [INDIANA BOTANIC GARDENS]3
CHAMOMILEACTIVE MOIETYFGL3685T2XHOMEOPATHIC EAR ACHE FORMULA (ACONITUM NAPELLUS, BELLADONNA, CAPSICUM, CHAMOMILE, FERRUM PHOSPHORICUM, KALI MURIATICUM) TABLET [INDIANA BOTANIC GARDENS]3
FERRUM PHOSPHORICUMACTIVE MOIETY91GQH8I5F7HOMEOPATHIC EAR ACHE FORMULA (ACONITUM NAPELLUS, BELLADONNA, CAPSICUM, CHAMOMILE, FERRUM PHOSPHORICUM, KALI MURIATICUM) TABLET [INDIANA BOTANIC GARDENS]3
POTASSIUM CATIONACTIVE MOIETY295O53K152HOMEOPATHIC EAR ACHE FORMULA (ACONITUM NAPELLUS, BELLADONNA, CAPSICUM, CHAMOMILE, FERRUM PHOSPHORICUM, KALI MURIATICUM) TABLET [INDIANA BOTANIC GARDENS]3
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2HOMEOPATHIC EAR ACHE FORMULA (ACONITUM NAPELLUS, BELLADONNA, CAPSICUM, CHAMOMILE, FERRUM PHOSPHORICUM, KALI MURIATICUM) TABLET [INDIANA BOTANIC GARDENS]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HOMEOPATHIC EAR ACHE FORMULA (ACONITUM NAPELLUS, BELLADONNA, CAPSICUM, CHAMOMILE, FERRUM PHOSPHORICUM, KALI MURIATICUM) TABLET [INDIANA BOTANIC GARDENS]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HOMEOPATHIC EAR ACHE FORMULA (ACONITUM NAPELLUS, BELLADONNA, CAPSICUM, CHAMOMILE, FERRUM PHOSPHORICUM, KALI MURIATICUM) TABLET [INDIANA BOTANIC GARDENS]3