Relaxatone

Product NDC
57520-0304
Requested package NDC
57520-0304-1
11-digit product format
575200304
Labeler code
57520
Product ID
57520-0304_f5721edf-f559-4da2-a1d6-22ee22e81427
Type
HUMAN OTC DRUG
Nonproprietary name
Passiflora incarnata, Scutellaria lateriflora, Valeriana officinalis, Arsenicum album, Calcarea carbonica, Coffea cruda, Ignatia amara, Kali phosphoricum Lycopus virginicus, Staphysagria
Dosage form
LIQUID
Route
ORAL
Labeler
Apotheca Company
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2010-11-11
Marketing end
2022-09-10
Substance
ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; DELPHINIUM STAPHISAGRIA SEED; LYCOPUS VIRGINICUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PASSIFLORA INCARNATA TOP; POTASSIUM PHOSPHATE, DIBASIC; SCUTELLARIA LATERIFLORA; STRYCHNOS IGNATII SEED; VALERIAN
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], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Potassium Compounds [CS], Potassium Salt [EPC], Seed Storage 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 packagepackage57520-030457520-0304-1DDiscontinued 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 · 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
57520-0304-12022-04-01C16284748780-19d75b9d1-0c7b-f424-e053-dadaa90a57ceRelaxatone
57520-0304-12020-01-31C16284748780-19d75b9d1-0c7b-f424-e053-dadaa90a57ceRelaxatone

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARABICA COFFEE BEANACTIVE INGREDIENT3SW678MX72RELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA, IGNATIA AMARA, KALI PHOSPHORICUM LYCOPUS VIRGINICUS, STAPHYSAGRIA) LIQUID [APOTHECA COMPANY]1
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HORELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA, IGNATIA AMARA, KALI PHOSPHORICUM LYCOPUS VIRGINICUS, STAPHYSAGRIA) LIQUID [APOTHECA COMPANY]1
DELPHINIUM STAPHISAGRIA SEEDACTIVE INGREDIENT00543AP1JVRELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA, IGNATIA AMARA, KALI PHOSPHORICUM LYCOPUS VIRGINICUS, STAPHYSAGRIA) LIQUID [APOTHECA COMPANY]1
LYCOPUS VIRGINICUSACTIVE INGREDIENTTWH5125Q6FRELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA, IGNATIA AMARA, KALI PHOSPHORICUM LYCOPUS VIRGINICUS, STAPHYSAGRIA) LIQUID [APOTHECA COMPANY]1
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE INGREDIENT2E32821G6IRELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA, IGNATIA AMARA, KALI PHOSPHORICUM LYCOPUS VIRGINICUS, STAPHYSAGRIA) LIQUID [APOTHECA COMPANY]1
PASSIFLORA INCARNATA TOPACTIVE INGREDIENTCLF5YFS11ORELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA, IGNATIA AMARA, KALI PHOSPHORICUM LYCOPUS VIRGINICUS, STAPHYSAGRIA) LIQUID [APOTHECA COMPANY]1
POTASSIUM PHOSPHATE, DIBASICACTIVE INGREDIENTCI71S98N1ZRELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA, IGNATIA AMARA, KALI PHOSPHORICUM LYCOPUS VIRGINICUS, STAPHYSAGRIA) LIQUID [APOTHECA COMPANY]1
SCUTELLARIA LATERIFLORAACTIVE INGREDIENT7BP4DH5PDCRELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA, IGNATIA AMARA, KALI PHOSPHORICUM LYCOPUS VIRGINICUS, STAPHYSAGRIA) LIQUID [APOTHECA COMPANY]1
STRYCHNOS IGNATII SEEDACTIVE INGREDIENT1NM3M2487KRELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA, IGNATIA AMARA, KALI PHOSPHORICUM LYCOPUS VIRGINICUS, STAPHYSAGRIA) LIQUID [APOTHECA COMPANY]1
VALERIANACTIVE INGREDIENTJWF5YAW3QWRELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA, IGNATIA AMARA, KALI PHOSPHORICUM LYCOPUS VIRGINICUS, STAPHYSAGRIA) LIQUID [APOTHECA COMPANY]1
ARABICA COFFEE BEANACTIVE MOIETY3SW678MX72RELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA, IGNATIA AMARA, KALI PHOSPHORICUM LYCOPUS VIRGINICUS, STAPHYSAGRIA) LIQUID [APOTHECA COMPANY]1
ARSENIC TRIOXIDEACTIVE MOIETYS7V92P67HORELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA, IGNATIA AMARA, KALI PHOSPHORICUM LYCOPUS VIRGINICUS, STAPHYSAGRIA) LIQUID [APOTHECA COMPANY]1
DELPHINIUM STAPHISAGRIA SEEDACTIVE MOIETY00543AP1JVRELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA, IGNATIA AMARA, KALI PHOSPHORICUM LYCOPUS VIRGINICUS, STAPHYSAGRIA) LIQUID [APOTHECA COMPANY]1
LYCOPUS VIRGINICUSACTIVE MOIETYTWH5125Q6FRELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA, IGNATIA AMARA, KALI PHOSPHORICUM LYCOPUS VIRGINICUS, STAPHYSAGRIA) LIQUID [APOTHECA COMPANY]1
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE MOIETY2E32821G6IRELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA, IGNATIA AMARA, KALI PHOSPHORICUM LYCOPUS VIRGINICUS, STAPHYSAGRIA) LIQUID [APOTHECA COMPANY]1
PASSIFLORA INCARNATA TOPACTIVE MOIETYCLF5YFS11ORELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA, IGNATIA AMARA, KALI PHOSPHORICUM LYCOPUS VIRGINICUS, STAPHYSAGRIA) LIQUID [APOTHECA COMPANY]1
POTASSIUM CATIONACTIVE MOIETY295O53K152RELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA, IGNATIA AMARA, KALI PHOSPHORICUM LYCOPUS VIRGINICUS, STAPHYSAGRIA) LIQUID [APOTHECA COMPANY]1
SCUTELLARIA LATERIFLORAACTIVE MOIETY7BP4DH5PDCRELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA, IGNATIA AMARA, KALI PHOSPHORICUM LYCOPUS VIRGINICUS, STAPHYSAGRIA) LIQUID [APOTHECA COMPANY]1
STRYCHNOS IGNATII SEEDACTIVE MOIETY1NM3M2487KRELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA, IGNATIA AMARA, KALI PHOSPHORICUM LYCOPUS VIRGINICUS, STAPHYSAGRIA) LIQUID [APOTHECA COMPANY]1
VALERIANACTIVE MOIETYJWF5YAW3QWRELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA, IGNATIA AMARA, KALI PHOSPHORICUM LYCOPUS VIRGINICUS, STAPHYSAGRIA) LIQUID [APOTHECA COMPANY]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MRELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA, IGNATIA AMARA, KALI PHOSPHORICUM LYCOPUS VIRGINICUS, STAPHYSAGRIA) LIQUID [APOTHECA COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RRELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA, IGNATIA AMARA, KALI PHOSPHORICUM LYCOPUS VIRGINICUS, STAPHYSAGRIA) LIQUID [APOTHECA COMPANY]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57520-0304-15752003040130 mL in 1 BOTTLE, DROPPER (57520-0304-1) 30 ml2010-11-112022-09-10NoNoCurrent