Sleep Well

Product NDC
71742-0006
11-digit product format
717420006
Labeler code
71742
Product ID
71742-0006_76adb01c-5f32-4d49-abfc-adfbd560d699
Type
HUMAN OTC DRUG
Nonproprietary name
Arsenicum Album, Avena Sativa, Coffea Cruda, Kali Carbonicum, Magnesia Carbonica, Nux Vomica, Passiflora Incarnata, Sepia, Valeriana Officinalis
Dosage form
LIQUID
Route
ORAL
Labeler
Guangzhou Renuma Medical Systems Co., Ltd
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2017-10-24
Substance
ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; MAGNESIUM CARBONATE; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM CARBONATE; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; VALERIAN
Active strength
30; 30; 30; 30; 30; 30; 30; 30; 30 [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], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Sleep Well
Brand name suffix
T012
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARSENIC TRIOXIDE30 [hp_X]/mL
AVENA SATIVA FLOWERING TOP30 [hp_X]/mL
ARABICA COFFEE BEAN30 [hp_X]/mL
POTASSIUM CARBONATE30 [hp_X]/mL
MAGNESIUM CARBONATE30 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED30 [hp_X]/mL
PASSIFLORA INCARNATA FLOWERING TOP30 [hp_X]/mL
SEPIA OFFICINALIS JUICE30 [hp_X]/mL
VALERIAN30 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 9 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S7V92P67HOInternal UNII lookup
MA9CQJ3F7FInternal UNII lookup
3SW678MX72Internal UNII lookup
BQN1B9B9HAInternal UNII lookup
0E53J927NAInternal UNII lookup
269XH13919Internal UNII lookup
CLF5YFS11OInternal UNII lookup
QDL83WN8C2Internal UNII lookup
JWF5YAW3QWInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2dc9026a-b847-403b-a92e-5d629e4b3c68Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71742-0006-1Sleep WellT01259 mL in 1 BOTTLE, DROPPERLIQUID591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71742-0006SLEEP WELL T012 (ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS) LIQUID [GUANGZHOU RENUMA MEDICAL SYSTEMS CO., LTD]1Current NDC, Legacy NDC, 1 package rows20171024_2dc9026a-b847-403b-a92e-5d629e4b3c68.zip

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sleep Well T012ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALISGuangzhou Renuma Medical Systems Co., Ltd2dc9026a-b847-403b-a92e-5d629e4b3c682017-10-24WarningsExact identifier
ndc (product): 71742-0006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71742-0006-17174200060159 mL in 1 BOTTLE, DROPPER (71742-0006-1) 59 ml2017-10-240000-00-00NoNoCurrent