Sleepy Jr

Product NDC
68703-316
Requested package NDC
68703-316-30
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…

Additional Listing Data#

Finished product
Yes
Brand name base
Sleepy Jr
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STRYCHNOS NUX-VOMICA SEED30 [hp_C]/1
MATRICARIA CHAMOMILLA FLOWERING TOP OIL30 [hp_C]/1
ARTEMISIA CINA FLOWER6 [hp_C]/1
COFFEA ARABICA FRUIT6 [hp_C]/1
CINCHONA OFFICINALIS BARK30 [hp_C]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
269XH13919Internal UNII lookup
SA8AR2W4ERInternal UNII lookup
28M1820ACTInternal UNII lookup
HOX6BEK27QInternal UNII lookup
S003A158SBInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
81a22c7c-69a5-ea2a-e053-2991aa0a1a5cAvailable on FDA.report

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

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
Sleepy JrCHAMOMILLA, CINA, CINCHONA, COFFEA CRUDA, NUX VOMSilver Star Brands81a22c7c-69a5-ea2a-e053-2991aa0a1a5c2024-12-03WarningsExact identifier
ndc (package): 68703-316-30
ndc (product): 68703-316
ndc11 (package): 68703031630

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 tablet2018-12-17NoNoCurrent