FDA.reportPublic FDA data

NDC 15631-0331-07 - PASSIFLORA INCARNATA

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
15631-0331
Requested NDC
15631-0331-07
Package NDCs from labels
15631-0331-0, 15631-0331-1, 15631-0331-2, 15631-0331-3, 15631-0331-4, 15631-0331-5, 15631-0331-6, 15631-0331-7, 15631-0331-07
Manufacturer
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc
Effective date
2021-10-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PASSIFLORA INCARNATA - Rxhomeo Private Limited d.b.a. Rxhomeo, IncRxhomeo Private Limited d.b.a. Rxhomeo, Inc2021-10-23HUMAN OTC DRUG LABEL
Rxhomeo Homeopathic ComboRxhomeo Private Limited d.b.a. | Rxhomeo Private Limited d.b.a. Rxhomeo, Inc2016-10-13HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
15631-0331-02020-03-243c2a9fa1-0d7a-48db-ac73-f6e74d0aba98
15631-0331-12020-03-243c2a9fa1-0d7a-48db-ac73-f6e74d0aba98
15631-0331-22020-03-243c2a9fa1-0d7a-48db-ac73-f6e74d0aba98
15631-0331-32020-03-243c2a9fa1-0d7a-48db-ac73-f6e74d0aba98
15631-0331-42020-03-243c2a9fa1-0d7a-48db-ac73-f6e74d0aba98
15631-0331-52020-03-243c2a9fa1-0d7a-48db-ac73-f6e74d0aba98
15631-0331-02020-01-313c2a9fa1-0d7a-48db-ac73-f6e74d0aba98
15631-0331-12020-01-313c2a9fa1-0d7a-48db-ac73-f6e74d0aba98
15631-0331-22020-01-313c2a9fa1-0d7a-48db-ac73-f6e74d0aba98
15631-0331-32020-01-313c2a9fa1-0d7a-48db-ac73-f6e74d0aba98
15631-0331-42020-01-313c2a9fa1-0d7a-48db-ac73-f6e74d0aba98
15631-0331-52020-01-313c2a9fa1-0d7a-48db-ac73-f6e74d0aba98

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15631-0331-0PASSIFLORA INCARNATA100 in 1 PACKAGEPELLET1004
15631-0331-1PASSIFLORA INCARNATA200 in 1 PACKAGEPELLET2004
15631-0331-2PASSIFLORA INCARNATA400 in 1 PACKAGEPELLET4004
15631-0331-3PASSIFLORA INCARNATA750 in 1 PACKAGEPELLET7504
15631-0331-4PASSIFLORA INCARNATA2500 in 1 PACKAGEPELLET25004
15631-0331-5PASSIFLORA INCARNATA12500 in 1 PACKAGEPELLET125004
15631-0331-6PASSIFLORA INCARNATA500 in 1 PACKAGEPELLET5004
15631-0331-7PASSIFLORA INCARNATA1000 in 1 PACKAGEPELLET10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15631-0331PASSIFLORA INCARNATA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]4Current NDC, Legacy NDC, 8 package rows20211024_3c2a9fa1-0d7a-48db-ac73-f6e74d0aba98.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PASSIFLORA INCARNATA FLOWERING TOPACTIVE INGREDIENTCLF5YFS11OPASSIFLORA INCARNATA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]2
PASSIFLORA INCARNATA FLOWERING TOPACTIVE MOIETYCLF5YFS11OPASSIFLORA INCARNATA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]2
SUCROSEINACTIVE INGREDIENTC151H8M554PASSIFLORA INCARNATA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 19 of 23 · 441 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hyperactivity-Mental FocusADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORANewton Laboratories, Inc.fecece1f-22bc-21dc-e053-6294a90ad0c32023-06-23WarningsExact identifier
unii: CLF5YFS11O
Hyperactivity-Mental FocusADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORANewton Laboratories, Inc.fed03a1c-0ea8-1f8e-e053-6394a90a04c02023-06-23WarningsExact identifier
unii: CLF5YFS11O
Hyperactivity-Mental FocusADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORANewton Laboratories, Inc.febf610e-e08a-4797-e053-6294a90a3eb52023-06-22WarningsExact identifier
unii: CLF5YFS11O
Grain and Seed AntigensAMARANTH, BAMBOO, BARLEY, BUCKWHEAT, CORN, FLAX SEED, LENTILS, MILLET, MILO, OAT, POPPY SEED, RICE, RYE, SESAME, SOYBEAN, SUGARCANE, SUNFLOWER SEED, WHEAT, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHURBioActive Nutritional, Inc.36ce44a5-e5ac-4eea-b76d-424dcd4e6b072023-06-20WarningsExact identifier
unii: C151H8M554
Kali PhosphoricumKALI PHOSPHORICUMRatis, LLC43284190-e5b0-4561-9e7a-f84d374d59132023-05-25WarningsExact identifier
unii: CI71S98N1Z
PeacefuliAVENA SATIVA, HUMULUS LUPULUS, PASSIFLORA INCARNATA, KALI PHOSPHORICUM, ANACARDIUM ORIENTALE, ARGENTUM NITRICUM, IGNATIA AMARARatis, LLCeb3bc662-3d3d-4e4d-8561-330ad0eb08f22023-05-25WarningsExact identifier
unii: CI71S98N1Z
unii: CLF5YFS11O
Pain ReliefDIBASIC POTASSIUM PHOSPHATE,HYPERICUM PERFORATUM,TOXICODENDRON PUBESCENS LEAF,BRYONIA ALBA ROOT AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHyland's Inc.a57ac701-c42d-6b2f-e053-2995a90a112d2023-05-08WarningsExact identifier
unii: CI71S98N1Z
Kali phosphoricumDIBASIC POTASSIUM PHOSPHATEBoiron8609d979-1e48-4152-e053-2991aa0a11a22023-04-11Exact identifier
unii: CI71S98N1Z
Kali phosphoricumDIBASIC POTASSIUM PHOSPHATEBoiron8609b2fe-c962-24aa-e053-2a91aa0a82882023-03-27Exact identifier
unii: CI71S98N1Z
Kali phosphoricumPOTASSIUM PHOSPHATE, DIBASICLaboratoires Boiron937f07e0-7be2-11e6-ae5d-424c583030312023-03-09WarningsExact identifier
unii: CI71S98N1Z
Kali PhosphoricumKALI PHOSPHORICUMHahnemann Laboratories, INC.f66e6f3f-4999-e60f-e053-2995a90ae5e02023-03-08Exact identifier
unii: CI71S98N1Z
Passiflora incarnataPASSIFLORA INCARNATA FLOWERING TOPBoiron865c4aad-7d88-3938-e053-2a91aa0afab62023-03-03Exact identifier
unii: CLF5YFS11O
Perfect SleepADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUSDeseret Biologicals, Inc.d29af0e7-0d04-47e3-9a50-d99c7e14b44d2023-02-20WarningsExact identifier
unii: CLF5YFS11O
Saccharum officinaleSUCROSEBoiron6858f374-8549-4b00-e053-2991aa0a5c3c2023-02-20Exact identifier
unii: C151H8M554
Saccharum OfficinaleSACCHARUM OFFICINALEHahnemann Laboratories, INC.f04b0ab3-af1c-ec2d-e053-2995a90a78552023-01-27Exact identifier
unii: C151H8M554
Kali phosphoricumDIBASIC POTASSIUM PHOSPHATEBoiron860a5c8e-6d7b-e64d-e053-2991aa0af8022023-01-23Exact identifier
unii: CI71S98N1Z
AllermilkTARAXACUM OFFICINALE, HYDRASTIS CANADENSIS, BENZOICUM ACIDUM, CHOLINUM, CINNAMIC ACID, EUGENOL, FOLIC ACID, HISTAMINUM HYDROCHLORICUM, L-ASPARAGINE (MONOHYDRATE), MENADIONE, OOPHORINUM (SUIS), PHENYL ISOTHIOCYANATE, PIPERINE, PROGESTERONE, QUERCETIN, RUTIN, SACCHARUM LACTIS, TYRAMINE, XANTHINE, COUMARINUM, FOLLICULINUM, FORMALINUM, GABA (GAMMA-AMINOBUTYRIC ACID), VANILLYLAMINE, APIOLUMDeseret Biologicals, Inc.c13cbfb9-1c1f-43b5-b218-e58c3c521f932023-01-12WarningsExact identifier
unii: J2B2A4N98G
Perfect SleepADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, UBIDECARENONUM, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, MELATONIN, PYRROLE, TRYPTOPHAN, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUSDeseret Biologicals, Inc.f267fff4-f331-49b8-bd48-7d383da522462023-01-11WarningsExact identifier
unii: CLF5YFS11O
Calm Anxiety and StressCLEMATIS VITALBA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, ORNITHOGALUM UMBELLATUM, FLOS, PASSIFLORA INCARNATA, ANGELICA SINENSIS, ARGENTUM NITRICUM, CACAO, LITHIUM CARBONICUM, PRUNUS CERASIFERA, FLOS, VALERIANA OFFICINALIS, PIPER METHYSTICUM, GLANDULA SUPRARENALIS SUIS, ACONITUM NAPELLUS, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, CALCAREA CARBONICA, COCCULUS INDICUS, IGNATIA AMARA, GELSEMIUM SEMPERVIRENSPro Weight Loss Inc.f5fb248f-e078-4dba-9bee-be0e803b6a132023-01-10WarningsExact identifier
unii: CLF5YFS11O
Chip CravingsCOUMARINUM, QUERCETIN, RUTIN, BAMBOO, BARLEY, POPPY SEED, CORN (ZEA MAYS), FLAX SEED (LINUM USITATISSIMUM), BUCKWHEAT (FAGOPYRUM ESULENTUM), MILLET, MILO, OAT, RICE, RYE, LENTILS, SESAME, AMARANTH, SOYBEAN, SUGARCANE (SACCHARUM OFFICINALE), SUNFLOWER SEED, WHEAT, AMARANTH, AVENA SATIVA, NATRUM SULPHURICUM, SARCOLACTICUM ACIDUM, TRITICUM REPENS, ADRENOCORTICOTROPHIN, SYCOTIC CO BACILLUSDr. Donna Restivo DC719ef104-88f3-4db5-9c3a-1ac9a1a63c262023-01-10WarningsExact identifier
unii: C151H8M554

Reported adverse events (FAERS/openFDA)#

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