Sinutone

Product NDC
57520-0295
Requested package NDC
57520-0295-1
11-digit product format
575200295
Labeler code
57520
Product ID
57520-0295_a0e013fc-b9cd-40ed-b96a-7a5f22fac4dd
Type
HUMAN OTC DRUG
Nonproprietary name
Echinacea, Hydrastis canadensis, Allium cepa, Ambrosia artemesiaefolia, Arsenicum album, Kali bichromicum, Nux moschata, Pulsatilla, Sepia, Solidago virgaurea,
Dosage form
LIQUID
Route
ORAL
Labeler
Apotheca Company
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2010-11-10
Marketing end
2022-09-24
Substance
AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; ECHINACEA; GOLDENSEAL; NUTMEG; ONION; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SOLIDAGO VIRGAUREA FLOWERING TOP
Active strength
12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage57520-029557520-0295-1DDiscontinued by firm2026-10-15

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 · 17 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…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
57520-0295-12022-04-05C16284748780-19d75b9d1-0c2a-f424-e053-dadaa90a57ceSinutone
57520-0295-12020-01-31C16284748780-19d75b9d1-0c2a-f424-e053-dadaa90a57ceSinutone

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMBROSIA ARTEMISIIFOLIAACTIVE INGREDIENT9W34L2CQ9ASINUTONE (ECHINACEA, HYDRASTIS CANADENSIS, ALLIUM CEPA, AMBROSIA ARTEMESIAEFOLIA, ARSENICUM ALBUM, KALI BICHROMICUM, NUX MOSCHATA, PULSATILLA, SEPIA, SOLIDAGO VIRGAUREA,) LIQUID [APOTHECA COMPANY]1
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HOSINUTONE (ECHINACEA, HYDRASTIS CANADENSIS, ALLIUM CEPA, AMBROSIA ARTEMESIAEFOLIA, ARSENICUM ALBUM, KALI BICHROMICUM, NUX MOSCHATA, PULSATILLA, SEPIA, SOLIDAGO VIRGAUREA,) LIQUID [APOTHECA COMPANY]1
ECHINACEAACTIVE INGREDIENT4N9P6CC1DXSINUTONE (ECHINACEA, HYDRASTIS CANADENSIS, ALLIUM CEPA, AMBROSIA ARTEMESIAEFOLIA, ARSENICUM ALBUM, KALI BICHROMICUM, NUX MOSCHATA, PULSATILLA, SEPIA, SOLIDAGO VIRGAUREA,) LIQUID [APOTHECA COMPANY]1
GOLDENSEALACTIVE INGREDIENTZW3Z11D0JVSINUTONE (ECHINACEA, HYDRASTIS CANADENSIS, ALLIUM CEPA, AMBROSIA ARTEMESIAEFOLIA, ARSENICUM ALBUM, KALI BICHROMICUM, NUX MOSCHATA, PULSATILLA, SEPIA, SOLIDAGO VIRGAUREA,) LIQUID [APOTHECA COMPANY]1
NUTMEGACTIVE INGREDIENTAEE24M3MQ9SINUTONE (ECHINACEA, HYDRASTIS CANADENSIS, ALLIUM CEPA, AMBROSIA ARTEMESIAEFOLIA, ARSENICUM ALBUM, KALI BICHROMICUM, NUX MOSCHATA, PULSATILLA, SEPIA, SOLIDAGO VIRGAUREA,) LIQUID [APOTHECA COMPANY]1
ONIONACTIVE INGREDIENT492225Q21HSINUTONE (ECHINACEA, HYDRASTIS CANADENSIS, ALLIUM CEPA, AMBROSIA ARTEMESIAEFOLIA, ARSENICUM ALBUM, KALI BICHROMICUM, NUX MOSCHATA, PULSATILLA, SEPIA, SOLIDAGO VIRGAUREA,) LIQUID [APOTHECA COMPANY]1
POTASSIUM DICHROMATEACTIVE INGREDIENTT4423S18FMSINUTONE (ECHINACEA, HYDRASTIS CANADENSIS, ALLIUM CEPA, AMBROSIA ARTEMESIAEFOLIA, ARSENICUM ALBUM, KALI BICHROMICUM, NUX MOSCHATA, PULSATILLA, SEPIA, SOLIDAGO VIRGAUREA,) LIQUID [APOTHECA COMPANY]1
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEVSINUTONE (ECHINACEA, HYDRASTIS CANADENSIS, ALLIUM CEPA, AMBROSIA ARTEMESIAEFOLIA, ARSENICUM ALBUM, KALI BICHROMICUM, NUX MOSCHATA, PULSATILLA, SEPIA, SOLIDAGO VIRGAUREA,) LIQUID [APOTHECA COMPANY]1
SEPIA OFFICINALIS JUICEACTIVE INGREDIENTQDL83WN8C2SINUTONE (ECHINACEA, HYDRASTIS CANADENSIS, ALLIUM CEPA, AMBROSIA ARTEMESIAEFOLIA, ARSENICUM ALBUM, KALI BICHROMICUM, NUX MOSCHATA, PULSATILLA, SEPIA, SOLIDAGO VIRGAUREA,) LIQUID [APOTHECA COMPANY]1
SOLIDAGO VIRGAUREA FLOWERING TOPACTIVE INGREDIENT5405K23S50SINUTONE (ECHINACEA, HYDRASTIS CANADENSIS, ALLIUM CEPA, AMBROSIA ARTEMESIAEFOLIA, ARSENICUM ALBUM, KALI BICHROMICUM, NUX MOSCHATA, PULSATILLA, SEPIA, SOLIDAGO VIRGAUREA,) LIQUID [APOTHECA COMPANY]1
AMBROSIA ARTEMISIIFOLIAACTIVE MOIETY9W34L2CQ9ASINUTONE (ECHINACEA, HYDRASTIS CANADENSIS, ALLIUM CEPA, AMBROSIA ARTEMESIAEFOLIA, ARSENICUM ALBUM, KALI BICHROMICUM, NUX MOSCHATA, PULSATILLA, SEPIA, SOLIDAGO VIRGAUREA,) LIQUID [APOTHECA COMPANY]1
ARSENIC TRIOXIDEACTIVE MOIETYS7V92P67HOSINUTONE (ECHINACEA, HYDRASTIS CANADENSIS, ALLIUM CEPA, AMBROSIA ARTEMESIAEFOLIA, ARSENICUM ALBUM, KALI BICHROMICUM, NUX MOSCHATA, PULSATILLA, SEPIA, SOLIDAGO VIRGAUREA,) LIQUID [APOTHECA COMPANY]1
ECHINACEAACTIVE MOIETY4N9P6CC1DXSINUTONE (ECHINACEA, HYDRASTIS CANADENSIS, ALLIUM CEPA, AMBROSIA ARTEMESIAEFOLIA, ARSENICUM ALBUM, KALI BICHROMICUM, NUX MOSCHATA, PULSATILLA, SEPIA, SOLIDAGO VIRGAUREA,) LIQUID [APOTHECA COMPANY]1
GOLDENSEALACTIVE MOIETYZW3Z11D0JVSINUTONE (ECHINACEA, HYDRASTIS CANADENSIS, ALLIUM CEPA, AMBROSIA ARTEMESIAEFOLIA, ARSENICUM ALBUM, KALI BICHROMICUM, NUX MOSCHATA, PULSATILLA, SEPIA, SOLIDAGO VIRGAUREA,) LIQUID [APOTHECA COMPANY]1
NUTMEGACTIVE MOIETYAEE24M3MQ9SINUTONE (ECHINACEA, HYDRASTIS CANADENSIS, ALLIUM CEPA, AMBROSIA ARTEMESIAEFOLIA, ARSENICUM ALBUM, KALI BICHROMICUM, NUX MOSCHATA, PULSATILLA, SEPIA, SOLIDAGO VIRGAUREA,) LIQUID [APOTHECA COMPANY]1
ONIONACTIVE MOIETY492225Q21HSINUTONE (ECHINACEA, HYDRASTIS CANADENSIS, ALLIUM CEPA, AMBROSIA ARTEMESIAEFOLIA, ARSENICUM ALBUM, KALI BICHROMICUM, NUX MOSCHATA, PULSATILLA, SEPIA, SOLIDAGO VIRGAUREA,) LIQUID [APOTHECA COMPANY]1
POTASSIUM CATIONACTIVE MOIETY295O53K152SINUTONE (ECHINACEA, HYDRASTIS CANADENSIS, ALLIUM CEPA, AMBROSIA ARTEMESIAEFOLIA, ARSENICUM ALBUM, KALI BICHROMICUM, NUX MOSCHATA, PULSATILLA, SEPIA, SOLIDAGO VIRGAUREA,) LIQUID [APOTHECA COMPANY]1
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEVSINUTONE (ECHINACEA, HYDRASTIS CANADENSIS, ALLIUM CEPA, AMBROSIA ARTEMESIAEFOLIA, ARSENICUM ALBUM, KALI BICHROMICUM, NUX MOSCHATA, PULSATILLA, SEPIA, SOLIDAGO VIRGAUREA,) LIQUID [APOTHECA COMPANY]1
SEPIA OFFICINALIS JUICEACTIVE MOIETYQDL83WN8C2SINUTONE (ECHINACEA, HYDRASTIS CANADENSIS, ALLIUM CEPA, AMBROSIA ARTEMESIAEFOLIA, ARSENICUM ALBUM, KALI BICHROMICUM, NUX MOSCHATA, PULSATILLA, SEPIA, SOLIDAGO VIRGAUREA,) LIQUID [APOTHECA COMPANY]1
SOLIDAGO VIRGAUREA FLOWERING TOPACTIVE MOIETY5405K23S50SINUTONE (ECHINACEA, HYDRASTIS CANADENSIS, ALLIUM CEPA, AMBROSIA ARTEMESIAEFOLIA, ARSENICUM ALBUM, KALI BICHROMICUM, NUX MOSCHATA, PULSATILLA, SEPIA, SOLIDAGO VIRGAUREA,) LIQUID [APOTHECA COMPANY]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MSINUTONE (ECHINACEA, HYDRASTIS CANADENSIS, ALLIUM CEPA, AMBROSIA ARTEMESIAEFOLIA, ARSENICUM ALBUM, KALI BICHROMICUM, NUX MOSCHATA, PULSATILLA, SEPIA, SOLIDAGO VIRGAUREA,) LIQUID [APOTHECA COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RSINUTONE (ECHINACEA, HYDRASTIS CANADENSIS, ALLIUM CEPA, AMBROSIA ARTEMESIAEFOLIA, ARSENICUM ALBUM, KALI BICHROMICUM, NUX MOSCHATA, PULSATILLA, SEPIA, SOLIDAGO VIRGAUREA,) LIQUID [APOTHECA COMPANY]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57520-0295-15752002950130 mL in 1 BOTTLE, DROPPER (57520-0295-1) 30 ml2010-11-102022-09-24NoNoCurrent