FDA.reportPublic FDA data

Sleep Disorder Drops

Product NDC
63083-2152
11-digit product format
630832152
Labeler code
63083
Product ID
63083-2152_cb77291c-0246-4516-82f9-857477cd8a4f
Type
HUMAN OTC DRUG
Nonproprietary name
Sleep Disorder Drops
Dosage form
LIQUID
Route
ORAL
Labeler
Professional Complementary Health Formulas
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1984-08-15
Substance
ACONITUM NAPELLUS WHOLE; AMBER; ARNICA MONTANA WHOLE; ARSENIC TRIOXIDE; ARTEMISIA ANNUA FLOWERING TOP; ASIAN GINSENG; BARIUM CARBONATE; GRAPHITE; MERCURIUS SOLUBILIS; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; RAUWOLFIA SERPENTINA; SCHISANDRIN B, (+/-)-; SEPIA OFFICINALIS JUICE; SULFUR
Active strength
9; 3; 12; 30; 3; 3; 9; 8; 30; 3; 9; 6; 3; 30; 12 [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; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sleep Disorder Drops
Brand name suffix
2152
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARTEMISIA ANNUA FLOWERING TOP9 [hp_X]/59mL
ASIAN GINSENG3 [hp_X]/59mL
PASSIFLORA INCARNATA FLOWERING TOP12 [hp_X]/59mL
SCHISANDRIN B, (+/-)-30 [hp_X]/59mL
AMBER3 [hp_X]/59mL
RAUWOLFIA SERPENTINA3 [hp_X]/59mL
GRAPHITE9 [hp_X]/59mL
ACONITUM NAPELLUS WHOLE8 [hp_X]/59mL
BARIUM CARBONATE30 [hp_X]/59mL
PHOSPHORUS3 [hp_X]/59mL
ARNICA MONTANA WHOLE9 [hp_X]/59mL
SULFUR6 [hp_X]/59mL
ARSENIC TRIOXIDE3 [hp_X]/59mL
MERCURIUS SOLUBILIS30 [hp_X]/59mL
SEPIA OFFICINALIS JUICE12 [hp_X]/59mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0UQK6O82OW, CUQ3A77YXI, CLF5YFS11O, 02XA4X3KZW, 70J9Z0J26P, H192N84N1G, 4QQN74LH4O, U0NQ8555JD, 6P669D8HQ8, 27YLU75U4W, O80TY208ZW, 70FD1KFU70, S7V92P67HO, 324Y4038G2, QDL83WN8C2

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63083-2152-22026-01-09C16284748780-11030e364-f945-111a-e063-dadaa90a10e2C152
63083-2152-22026-01-09C16284748780-11030e364-f945-111a-e063-dadaa90a10e2C152
63083-2152-22024-01-30C16284748780-11030e364-f945-111a-e063-dadaa90a10e2C152
63083-2152-22024-01-30C16284748780-11030e364-f945-111a-e063-dadaa90a10e2C152

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-2152-2Sleep Disorder Drops215259 mL in 1 BOTTLE, DROPPERLIQUID592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63083-2152SLEEP DISORDER DROPS 2152 (SLEEP DISORDER DROPS) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS]1Current NDC, Legacy NDC, 1 package rows20220216_55af88df-8e5a-4e84-a8f6-fc3063d91381.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63083-2152-26308321520259 mL in 1 BOTTLE, DROPPER (63083-2152-2) 59 ml1985-08-150000-00-00NoNoCurrent