FDA.reportPublic FDA data

Bio Reset Jet Lag/Shift Change

Product NDC
66579-0055
11-digit product format
665790055
Labeler code
66579
Product ID
66579-0055_b46b5e93-2d25-497b-9482-20a75633d2a1
Type
HUMAN OTC DRUG
Nonproprietary name
Cocculus indicus, Colchicum autumnale, Gelsemium sempervirens, Juniperus communis, Kali carbonicum, Kali phosphoricum Nux vomica, Passiflora incarnata, Phosphoricum acidum, Phosphorus
Dosage form
LIQUID
Route
ORAL
Labeler
New Sun Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2011-01-06
Marketing end
0000-00-00
Substance
ANAMIRTA COCCULUS SEED; COLCHICUM AUTUMNALE BULB; GELSEMIUM SEMPERVIRENS ROOT; JUNIPER BERRY; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORIC ACID; PHOSPHORUS
Active strength
10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66579-0055-22020-01-31C16284748780-19d75b9d0-bdbb-f424-e053-dadaa90a57ceBio Reset Jet Lag/Shift

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66579-0055-2Bio Reset Jet Lag/Shift Change59 mL in 1 BOTTLE, SPRAYLIQUID591

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANAMIRTA COCCULUS SEEDACTIVE INGREDIENT810258W28UBIO RESET JET LAG/SHIFT CHANGE (COCCULUS INDICUS, COLCHICUM AUTUMNALE, GELSEMIUM SEMPERVIRENS, JUNIPERUS COMMUNIS, KALI CARBONICUM, KALI PHOSPHORICUM NUX VOMICA, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, PHOSPHORUS) LIQUID [NEW SUN INC.]1
COLCHICUM AUTUMNALE BULBACTIVE INGREDIENT993QHL78E6BIO RESET JET LAG/SHIFT CHANGE (COCCULUS INDICUS, COLCHICUM AUTUMNALE, GELSEMIUM SEMPERVIRENS, JUNIPERUS COMMUNIS, KALI CARBONICUM, KALI PHOSPHORICUM NUX VOMICA, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, PHOSPHORUS) LIQUID [NEW SUN INC.]1
GELSEMIUM SEMPERVIRENS ROOTACTIVE INGREDIENT639KR60Q1QBIO RESET JET LAG/SHIFT CHANGE (COCCULUS INDICUS, COLCHICUM AUTUMNALE, GELSEMIUM SEMPERVIRENS, JUNIPERUS COMMUNIS, KALI CARBONICUM, KALI PHOSPHORICUM NUX VOMICA, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, PHOSPHORUS) LIQUID [NEW SUN INC.]1
JUNIPER BERRYACTIVE INGREDIENTO84B5194RLBIO RESET JET LAG/SHIFT CHANGE (COCCULUS INDICUS, COLCHICUM AUTUMNALE, GELSEMIUM SEMPERVIRENS, JUNIPERUS COMMUNIS, KALI CARBONICUM, KALI PHOSPHORICUM NUX VOMICA, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, PHOSPHORUS) LIQUID [NEW SUN INC.]1
PASSIFLORA INCARNATA FLOWERING TOPACTIVE INGREDIENTCLF5YFS11OBIO RESET JET LAG/SHIFT CHANGE (COCCULUS INDICUS, COLCHICUM AUTUMNALE, GELSEMIUM SEMPERVIRENS, JUNIPERUS COMMUNIS, KALI CARBONICUM, KALI PHOSPHORICUM NUX VOMICA, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, PHOSPHORUS) LIQUID [NEW SUN INC.]1
PHOSPHORIC ACIDACTIVE INGREDIENTE4GA8884NNBIO RESET JET LAG/SHIFT CHANGE (COCCULUS INDICUS, COLCHICUM AUTUMNALE, GELSEMIUM SEMPERVIRENS, JUNIPERUS COMMUNIS, KALI CARBONICUM, KALI PHOSPHORICUM NUX VOMICA, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, PHOSPHORUS) LIQUID [NEW SUN INC.]1
PHOSPHORUSACTIVE INGREDIENT27YLU75U4WBIO RESET JET LAG/SHIFT CHANGE (COCCULUS INDICUS, COLCHICUM AUTUMNALE, GELSEMIUM SEMPERVIRENS, JUNIPERUS COMMUNIS, KALI CARBONICUM, KALI PHOSPHORICUM NUX VOMICA, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, PHOSPHORUS) LIQUID [NEW SUN INC.]1
POTASSIUM CARBONATEACTIVE INGREDIENTBQN1B9B9HABIO RESET JET LAG/SHIFT CHANGE (COCCULUS INDICUS, COLCHICUM AUTUMNALE, GELSEMIUM SEMPERVIRENS, JUNIPERUS COMMUNIS, KALI CARBONICUM, KALI PHOSPHORICUM NUX VOMICA, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, PHOSPHORUS) LIQUID [NEW SUN INC.]1
POTASSIUM PHOSPHATE, DIBASICACTIVE INGREDIENTCI71S98N1ZBIO RESET JET LAG/SHIFT CHANGE (COCCULUS INDICUS, COLCHICUM AUTUMNALE, GELSEMIUM SEMPERVIRENS, JUNIPERUS COMMUNIS, KALI CARBONICUM, KALI PHOSPHORICUM NUX VOMICA, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, PHOSPHORUS) LIQUID [NEW SUN INC.]1
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH13919BIO RESET JET LAG/SHIFT CHANGE (COCCULUS INDICUS, COLCHICUM AUTUMNALE, GELSEMIUM SEMPERVIRENS, JUNIPERUS COMMUNIS, KALI CARBONICUM, KALI PHOSPHORICUM NUX VOMICA, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, PHOSPHORUS) LIQUID [NEW SUN INC.]1
ANAMIRTA COCCULUS SEEDACTIVE MOIETY810258W28UBIO RESET JET LAG/SHIFT CHANGE (COCCULUS INDICUS, COLCHICUM AUTUMNALE, GELSEMIUM SEMPERVIRENS, JUNIPERUS COMMUNIS, KALI CARBONICUM, KALI PHOSPHORICUM NUX VOMICA, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, PHOSPHORUS) LIQUID [NEW SUN INC.]1
CARBONATE IONACTIVE MOIETY7UJQ5OPE7DBIO RESET JET LAG/SHIFT CHANGE (COCCULUS INDICUS, COLCHICUM AUTUMNALE, GELSEMIUM SEMPERVIRENS, JUNIPERUS COMMUNIS, KALI CARBONICUM, KALI PHOSPHORICUM NUX VOMICA, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, PHOSPHORUS) LIQUID [NEW SUN INC.]1
COLCHICUM AUTUMNALE BULBACTIVE MOIETY993QHL78E6BIO RESET JET LAG/SHIFT CHANGE (COCCULUS INDICUS, COLCHICUM AUTUMNALE, GELSEMIUM SEMPERVIRENS, JUNIPERUS COMMUNIS, KALI CARBONICUM, KALI PHOSPHORICUM NUX VOMICA, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, PHOSPHORUS) LIQUID [NEW SUN INC.]1
GELSEMIUM SEMPERVIRENS ROOTACTIVE MOIETY639KR60Q1QBIO RESET JET LAG/SHIFT CHANGE (COCCULUS INDICUS, COLCHICUM AUTUMNALE, GELSEMIUM SEMPERVIRENS, JUNIPERUS COMMUNIS, KALI CARBONICUM, KALI PHOSPHORICUM NUX VOMICA, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, PHOSPHORUS) LIQUID [NEW SUN INC.]1
JUNIPER BERRYACTIVE MOIETYO84B5194RLBIO RESET JET LAG/SHIFT CHANGE (COCCULUS INDICUS, COLCHICUM AUTUMNALE, GELSEMIUM SEMPERVIRENS, JUNIPERUS COMMUNIS, KALI CARBONICUM, KALI PHOSPHORICUM NUX VOMICA, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, PHOSPHORUS) LIQUID [NEW SUN INC.]1
PASSIFLORA INCARNATA FLOWERING TOPACTIVE MOIETYCLF5YFS11OBIO RESET JET LAG/SHIFT CHANGE (COCCULUS INDICUS, COLCHICUM AUTUMNALE, GELSEMIUM SEMPERVIRENS, JUNIPERUS COMMUNIS, KALI CARBONICUM, KALI PHOSPHORICUM NUX VOMICA, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, PHOSPHORUS) LIQUID [NEW SUN INC.]1
PHOSPHATE IONACTIVE MOIETYNK08V8K8HRBIO RESET JET LAG/SHIFT CHANGE (COCCULUS INDICUS, COLCHICUM AUTUMNALE, GELSEMIUM SEMPERVIRENS, JUNIPERUS COMMUNIS, KALI CARBONICUM, KALI PHOSPHORICUM NUX VOMICA, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, PHOSPHORUS) LIQUID [NEW SUN INC.]1
PHOSPHORIC ACIDACTIVE MOIETYE4GA8884NNBIO RESET JET LAG/SHIFT CHANGE (COCCULUS INDICUS, COLCHICUM AUTUMNALE, GELSEMIUM SEMPERVIRENS, JUNIPERUS COMMUNIS, KALI CARBONICUM, KALI PHOSPHORICUM NUX VOMICA, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, PHOSPHORUS) LIQUID [NEW SUN INC.]1
PHOSPHORUSACTIVE MOIETY27YLU75U4WBIO RESET JET LAG/SHIFT CHANGE (COCCULUS INDICUS, COLCHICUM AUTUMNALE, GELSEMIUM SEMPERVIRENS, JUNIPERUS COMMUNIS, KALI CARBONICUM, KALI PHOSPHORICUM NUX VOMICA, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, PHOSPHORUS) LIQUID [NEW SUN INC.]1
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH13919BIO RESET JET LAG/SHIFT CHANGE (COCCULUS INDICUS, COLCHICUM AUTUMNALE, GELSEMIUM SEMPERVIRENS, JUNIPERUS COMMUNIS, KALI CARBONICUM, KALI PHOSPHORICUM NUX VOMICA, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, PHOSPHORUS) LIQUID [NEW SUN INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBIO RESET JET LAG/SHIFT CHANGE (COCCULUS INDICUS, COLCHICUM AUTUMNALE, GELSEMIUM SEMPERVIRENS, JUNIPERUS COMMUNIS, KALI CARBONICUM, KALI PHOSPHORICUM NUX VOMICA, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, PHOSPHORUS) LIQUID [NEW SUN INC.]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4BIO RESET JET LAG/SHIFT CHANGE (COCCULUS INDICUS, COLCHICUM AUTUMNALE, GELSEMIUM SEMPERVIRENS, JUNIPERUS COMMUNIS, KALI CARBONICUM, KALI PHOSPHORICUM NUX VOMICA, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, PHOSPHORUS) LIQUID [NEW SUN INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RBIO RESET JET LAG/SHIFT CHANGE (COCCULUS INDICUS, COLCHICUM AUTUMNALE, GELSEMIUM SEMPERVIRENS, JUNIPERUS COMMUNIS, KALI CARBONICUM, KALI PHOSPHORICUM NUX VOMICA, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, PHOSPHORUS) LIQUID [NEW SUN INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66579-0055BIO RESET JET LAG/SHIFT CHANGE (COCCULUS INDICUS, COLCHICUM AUTUMNALE, GELSEMIUM SEMPERVIRENS, JUNIPERUS COMMUNIS, KALI CARBONICUM, KALI PHOSPHORICUM NUX VOMICA, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, PHOSPHORUS) LIQUID [NEW SUN INC.]1Legacy NDC, 1 package rows20141024_c373810d-f588-4245-8816-80fa059841c3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
66579-0055-26657900550259 mL in 1 BOTTLE, SPRAY59 mlHistorical