Insomnia Drops

Product NDC
63083-2035
11-digit product format
630832035
Labeler code
63083
Product ID
63083-2035_6753949b-9e6e-4731-a090-80b34121f204
Type
HUMAN OTC DRUG
Nonproprietary name
Insomnia Drops
Dosage form
LIQUID
Route
ORAL
Labeler
Professional Complementary Health Formulas
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1984-08-15
Substance
ARABICA COFFEE BEAN; ARTEMISIA ANNUA FLOWERING TOP; AVENA SATIVA FLOWERING TOP; PASSIFLORA INCARNATA FLOWERING TOP; PAULLINIA CUPANA SEED; VALERIAN; ZINC
Active strength
6; 1; 2; 6; 24; 1; 3 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Insomnia Drops
Brand name suffix
2035
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARABICA COFFEE BEAN6 [hp_X]/59mL
ARTEMISIA ANNUA FLOWERING TOP1 [hp_X]/59mL
AVENA SATIVA FLOWERING TOP2 [hp_X]/59mL
PASSIFLORA INCARNATA FLOWERING TOP6 [hp_X]/59mL
PAULLINIA CUPANA SEED24 [hp_X]/59mL
VALERIAN1 [hp_X]/59mL
ZINC3 [hp_X]/59mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3SW678MX72, 0UQK6O82OW, MA9CQJ3F7F, CLF5YFS11O, C21GE7524R, JWF5YAW3QW, J41CSQ7QDS

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63083-2035-22026-01-09C16284748780-11030e365-1b72-111a-e063-dadaa90a10e2C35
63083-2035-22026-01-09C16284748780-11030e365-1b72-111a-e063-dadaa90a10e2C35
63083-2035-22024-01-30C16284748780-11030e365-1b72-111a-e063-dadaa90a10e2C35
63083-2035-22024-01-30C16284748780-11030e365-1b72-111a-e063-dadaa90a10e2C35

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-2035-2Insomnia Drops203559 mL in 1 BOTTLE, DROPPERLIQUID592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63083-2035INSOMNIA DROPS 2035 (INSOMNIA DROPS) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS]1Current NDC, Legacy NDC, 1 package rows20220215_49dcc73f-2a20-4938-8671-0fa9dd39d5b8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63083-2035-26308320350259 mL in 1 BOTTLE, DROPPER (63083-2035-2) 59 ml1985-08-150000-00-00NoNoCurrent