Cystotone

Product NDC
57520-0417
11-digit product format
575200417
Labeler code
57520
Product ID
57520-0417_8165f760-bf95-4b66-a854-0e0527969ee2
Type
HUMAN OTC DRUG
Nonproprietary name
Sarsaparilla, Uva-ursi, Arsenicum album, Cantharis, Pareira brava, Pulsatilla, Sepia, Terebinthina, Populus tremuloides
Dosage form
LIQUID
Route
ORAL
Labeler
Apotheca Company
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2010-05-17
Marketing end
2022-09-20
Substance
ARCTOSTAPHYLOS UVA-URSI LEAF; ARSENIC TRIOXIDE; CHONDRODENDRON TOMENTOSUM ROOT; LYTTA VESICATORIA; POPULUS TREMULOIDES LEAF; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SMILAX ORNATA ROOT; TURPENTINE
Active strength
3 [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
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57520-0417DDiscontinued by firm2026-10-05
excluded packagepackage57520-041757520-0417-1DDiscontinued 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 · 32 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 packagepackage57520-0417-1DDiscontinued 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 packagepackage57520-0417-1DDiscontinued 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 packagepackage57520-0417-1DDiscontinued 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 packagepackage57520-0417-1DDiscontinued 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 packagepackage57520-0417-1DDiscontinued 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 packagepackage57520-0417-1DDiscontinued 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 packagepackage57520-0417-1DDiscontinued 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 packagepackage57520-0417-1DDiscontinued 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 packagepackage57520-0417-1DDiscontinued 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 packagepackage57520-0417-1DDiscontinued 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 packagepackage57520-0417-1DDiscontinued 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 packagepackage57520-0417-1DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage57520-0417-1IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage57520-0417-1IInactivated 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 packagepackage57520-0417-1IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage57520-0417-1EExcluded 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
57520-0417-12022-03-24C16284748780-19d75b9d1-008a-f424-e053-dadaa90a57ceCystotone
57520-0417-12020-01-31C16284748780-19d75b9d1-008a-f424-e053-dadaa90a57ceCystotone

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARCTOSTAPHYLOS UVA-URSI LEAFACTIVE INGREDIENT3M5V3D1X36CYSTOTONE (SARSAPARILLA, UVA-URSI, ARSENICUM ALBUM, CANTHARIS, PAREIRA BRAVA, PULSATILLA, SEPIA, TEREBINTHINA, POPULUS TREMULOIDES) LIQUID [APOTHECA COMPANY]1
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HOCYSTOTONE (SARSAPARILLA, UVA-URSI, ARSENICUM ALBUM, CANTHARIS, PAREIRA BRAVA, PULSATILLA, SEPIA, TEREBINTHINA, POPULUS TREMULOIDES) LIQUID [APOTHECA COMPANY]1
CHONDRODENDRON TOMENTOSUM ROOTACTIVE INGREDIENT395A3P448ZCYSTOTONE (SARSAPARILLA, UVA-URSI, ARSENICUM ALBUM, CANTHARIS, PAREIRA BRAVA, PULSATILLA, SEPIA, TEREBINTHINA, POPULUS TREMULOIDES) LIQUID [APOTHECA COMPANY]1
LYTTA VESICATORIAACTIVE INGREDIENT3Q034RO3BTCYSTOTONE (SARSAPARILLA, UVA-URSI, ARSENICUM ALBUM, CANTHARIS, PAREIRA BRAVA, PULSATILLA, SEPIA, TEREBINTHINA, POPULUS TREMULOIDES) LIQUID [APOTHECA COMPANY]1
POPULUS TREMULOIDES LEAFACTIVE INGREDIENT7IIH57D9E0CYSTOTONE (SARSAPARILLA, UVA-URSI, ARSENICUM ALBUM, CANTHARIS, PAREIRA BRAVA, PULSATILLA, SEPIA, TEREBINTHINA, POPULUS TREMULOIDES) LIQUID [APOTHECA COMPANY]1
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEVCYSTOTONE (SARSAPARILLA, UVA-URSI, ARSENICUM ALBUM, CANTHARIS, PAREIRA BRAVA, PULSATILLA, SEPIA, TEREBINTHINA, POPULUS TREMULOIDES) LIQUID [APOTHECA COMPANY]1
SARSAPARILLAACTIVE INGREDIENT2H1576D5WGCYSTOTONE (SARSAPARILLA, UVA-URSI, ARSENICUM ALBUM, CANTHARIS, PAREIRA BRAVA, PULSATILLA, SEPIA, TEREBINTHINA, POPULUS TREMULOIDES) LIQUID [APOTHECA COMPANY]1
SEPIA OFFICINALIS JUICEACTIVE INGREDIENTQDL83WN8C2CYSTOTONE (SARSAPARILLA, UVA-URSI, ARSENICUM ALBUM, CANTHARIS, PAREIRA BRAVA, PULSATILLA, SEPIA, TEREBINTHINA, POPULUS TREMULOIDES) LIQUID [APOTHECA COMPANY]1
TURPENTINEACTIVE INGREDIENTXJ6RUH0O4GCYSTOTONE (SARSAPARILLA, UVA-URSI, ARSENICUM ALBUM, CANTHARIS, PAREIRA BRAVA, PULSATILLA, SEPIA, TEREBINTHINA, POPULUS TREMULOIDES) LIQUID [APOTHECA COMPANY]1
ARCTOSTAPHYLOS UVA-URSI LEAFACTIVE MOIETY3M5V3D1X36CYSTOTONE (SARSAPARILLA, UVA-URSI, ARSENICUM ALBUM, CANTHARIS, PAREIRA BRAVA, PULSATILLA, SEPIA, TEREBINTHINA, POPULUS TREMULOIDES) LIQUID [APOTHECA COMPANY]1
ARSENIC TRIOXIDEACTIVE MOIETYS7V92P67HOCYSTOTONE (SARSAPARILLA, UVA-URSI, ARSENICUM ALBUM, CANTHARIS, PAREIRA BRAVA, PULSATILLA, SEPIA, TEREBINTHINA, POPULUS TREMULOIDES) LIQUID [APOTHECA COMPANY]1
CHONDRODENDRON TOMENTOSUM ROOTACTIVE MOIETY395A3P448ZCYSTOTONE (SARSAPARILLA, UVA-URSI, ARSENICUM ALBUM, CANTHARIS, PAREIRA BRAVA, PULSATILLA, SEPIA, TEREBINTHINA, POPULUS TREMULOIDES) LIQUID [APOTHECA COMPANY]1
LYTTA VESICATORIAACTIVE MOIETY3Q034RO3BTCYSTOTONE (SARSAPARILLA, UVA-URSI, ARSENICUM ALBUM, CANTHARIS, PAREIRA BRAVA, PULSATILLA, SEPIA, TEREBINTHINA, POPULUS TREMULOIDES) LIQUID [APOTHECA COMPANY]1
POPULUS TREMULOIDES LEAFACTIVE MOIETY7IIH57D9E0CYSTOTONE (SARSAPARILLA, UVA-URSI, ARSENICUM ALBUM, CANTHARIS, PAREIRA BRAVA, PULSATILLA, SEPIA, TEREBINTHINA, POPULUS TREMULOIDES) LIQUID [APOTHECA COMPANY]1
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEVCYSTOTONE (SARSAPARILLA, UVA-URSI, ARSENICUM ALBUM, CANTHARIS, PAREIRA BRAVA, PULSATILLA, SEPIA, TEREBINTHINA, POPULUS TREMULOIDES) LIQUID [APOTHECA COMPANY]1
SARSAPARILLAACTIVE MOIETY2H1576D5WGCYSTOTONE (SARSAPARILLA, UVA-URSI, ARSENICUM ALBUM, CANTHARIS, PAREIRA BRAVA, PULSATILLA, SEPIA, TEREBINTHINA, POPULUS TREMULOIDES) LIQUID [APOTHECA COMPANY]1
SEPIA OFFICINALIS JUICEACTIVE MOIETYQDL83WN8C2CYSTOTONE (SARSAPARILLA, UVA-URSI, ARSENICUM ALBUM, CANTHARIS, PAREIRA BRAVA, PULSATILLA, SEPIA, TEREBINTHINA, POPULUS TREMULOIDES) LIQUID [APOTHECA COMPANY]1
TURPENTINEACTIVE MOIETYXJ6RUH0O4GCYSTOTONE (SARSAPARILLA, UVA-URSI, ARSENICUM ALBUM, CANTHARIS, PAREIRA BRAVA, PULSATILLA, SEPIA, TEREBINTHINA, POPULUS TREMULOIDES) LIQUID [APOTHECA COMPANY]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MCYSTOTONE (SARSAPARILLA, UVA-URSI, ARSENICUM ALBUM, CANTHARIS, PAREIRA BRAVA, PULSATILLA, SEPIA, TEREBINTHINA, POPULUS TREMULOIDES) LIQUID [APOTHECA COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RCYSTOTONE (SARSAPARILLA, UVA-URSI, ARSENICUM ALBUM, CANTHARIS, PAREIRA BRAVA, PULSATILLA, SEPIA, TEREBINTHINA, POPULUS TREMULOIDES) LIQUID [APOTHECA COMPANY]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57520-0417-15752004170130 mL in 1 BOTTLE, DROPPER (57520-0417-1) 30 ml2010-05-172022-09-20NoNoCurrent