Sleepy Jr

Product NDC
68703-316
11-digit product format
687030316
Labeler code
68703
Product ID
68703-316_28687c5e-f464-d9eb-e063-6394a90a9427
Type
HUMAN OTC DRUG
Nonproprietary name
Chamomilla, Cina, Cinchona, Coffea cruda, Nux vom
Dosage form
TABLET
Route
ORAL
Labeler
Silver Star Brands
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2018-12-17
Substance
ARTEMISIA CINA FLOWER; CINCHONA OFFICINALIS BARK; COFFEA ARABICA FRUIT; MATRICARIA CHAMOMILLA FLOWERING TOP OIL; STRYCHNOS NUX-VOMICA SEED
Active strength
30; 30; 6; 6; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage 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
Sleepy Jr
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARTEMISIA CINA FLOWER30 [hp_C]/1
CINCHONA OFFICINALIS BARK30 [hp_C]/1
COFFEA ARABICA FRUIT6 [hp_C]/1
MATRICARIA CHAMOMILLA FLOWERING TOP OIL6 [hp_C]/1
STRYCHNOS NUX-VOMICA SEED30 [hp_C]/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii28M1820ACT, S003A158SB, HOX6BEK27Q, SA8AR2W4ER, 269XH13919

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68703-316-302023-03-06C16284748780-1ba0f9c33-3b91-a910-e053-dadaa90a0b85NativeRemedies® Sleepy Jr.™
68703-316-302021-01-29C16284748780-1ba0f9c33-3b91-a910-e053-dadaa90a0b85NativeRemedies® Sleepy Jr.™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68703-316-30Sleepy Jr180 in 1 BOTTLE, GLASSTABLET1803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68703-316SLEEPY JR (CHAMOMILLA, CINA, CINCHONA, COFFEA CRUDA, NUX VOM) TABLET [SILVER STAR BRANDS]3Current NDC, Legacy NDC, 1 package rows20241207_81a22c7c-69a5-ea2a-e053-2991aa0a1a5c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68703-316-3068703031630180 TABLET in 1 BOTTLE, GLASS (68703-316-30) 180 tablet2018-12-17NoNoHistorical