FDA.reportPublic FDA data

Sleep gummies

Product NDC
83739-004
11-digit product format
837390004
Labeler code
83739
Product ID
83739-004_2e4f9fab-aa87-dfe2-e063-6294a90aa5b9
Type
HUMAN OTC DRUG
Nonproprietary name
Sleep gummies
Dosage form
CHEWABLE GEL
Route
ORAL
Labeler
XIAN CHIANG COMPANY LIMITED
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-10-14
Substance
AMINO ACIDS; BARLEY MALT
Active strength
2; 1 g/1001; g/1001
Pharmacologic classes
Allergens [CS], Amino Acid Hypertonic Solution [EPC], Amino Acids [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sleep gummies
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMINO ACIDS2 g/1001
BARLEY MALT1 g/1001

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0O72R8RF8A, R3NBG8914U

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83739-004-012025-02-17C16284748780-12cef2736-75c2-d83d-e063-dadaa90ab31f83739-004
83739-004-012025-01-30C16284748780-12cef2736-75c2-d83d-e063-dadaa90ab31f83739-004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83739-004-01Sleep gummies60 in 1 BOTTLECHEWABLE GEL602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83739-004SLEEP GUMMIES CHEWABLE GEL [XIAN CHIANG COMPANY LIMITED]2Current NDC, 1 package rows20250221_07a88f30-6a66-40d5-e063-6394a90a19a3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83739-004-018373900040160 CHEWABLE GEL in 1 BOTTLE (83739-004-01) 60 chewable gel2023-10-14NoNoCurrent