Sleep Assist

Product NDC
43689-0002
11-digit product format
436890002
Labeler code
43689
Product ID
43689-0002_1924e828-2bb6-4a22-b460-a8b23e4c81ca
Type
HUMAN OTC DRUG
Nonproprietary name
Chamomilla, Coffea cruda, Avena sativa, Nux Vomica, Passiflora incarnata,
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
The Magni Company
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2012-09-10
Marketing end
0000-00-00
Substance
MATRICARIA CHAMOMILLA WHOLE; ARABICA COFFEE BEAN; AVENA SATIVA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA FLOWERING TOP
Active strength
4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43689-0002DDiscontinued by firm2026-10-15
excluded packagepackage43689-000243689-0002-1DDiscontinued by firm2026-10-15

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43689-0002-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43689-0002-1DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43689-0002-1DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43689-0002-1DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43689-0002-1DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43689-0002-1DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43689-0002-1DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43689-0002-1DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43689-0002-1DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43689-0002-1DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43689-0002-1DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43689-0002-1DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage43689-0002-1IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage43689-0002-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage43689-0002-1IInactivated by FDA9bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43689-0002-12022-01-10C16284748780-19d75b9d0-8833-f424-e053-dadaa90a57ceSleep Assist
43689-0002-12020-01-31C16284748780-19d75b9d0-8833-f424-e053-dadaa90a57ceSleep Assist

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARABICA COFFEE BEANACTIVE INGREDIENT3SW678MX72SLEEP ASSIST (CHAMOMILLA, COFFEA CRUDA, AVENA SATIVA, NUX VOMICA, PASSIFLORA INCARNATA,) TABLET, ORALLY DISINTEGRATING [THE MAGNI COMPANY]2
AVENA SATIVA FLOWERING TOPACTIVE INGREDIENTMA9CQJ3F7FSLEEP ASSIST (CHAMOMILLA, COFFEA CRUDA, AVENA SATIVA, NUX VOMICA, PASSIFLORA INCARNATA,) TABLET, ORALLY DISINTEGRATING [THE MAGNI COMPANY]2
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZSLEEP ASSIST (CHAMOMILLA, COFFEA CRUDA, AVENA SATIVA, NUX VOMICA, PASSIFLORA INCARNATA,) TABLET, ORALLY DISINTEGRATING [THE MAGNI COMPANY]2
PASSIFLORA INCARNATA FLOWERING TOPACTIVE INGREDIENTCLF5YFS11OSLEEP ASSIST (CHAMOMILLA, COFFEA CRUDA, AVENA SATIVA, NUX VOMICA, PASSIFLORA INCARNATA,) TABLET, ORALLY DISINTEGRATING [THE MAGNI COMPANY]2
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH13919SLEEP ASSIST (CHAMOMILLA, COFFEA CRUDA, AVENA SATIVA, NUX VOMICA, PASSIFLORA INCARNATA,) TABLET, ORALLY DISINTEGRATING [THE MAGNI COMPANY]2
ARABICA COFFEE BEANACTIVE MOIETY3SW678MX72SLEEP ASSIST (CHAMOMILLA, COFFEA CRUDA, AVENA SATIVA, NUX VOMICA, PASSIFLORA INCARNATA,) TABLET, ORALLY DISINTEGRATING [THE MAGNI COMPANY]2
AVENA SATIVA FLOWERING TOPACTIVE MOIETYMA9CQJ3F7FSLEEP ASSIST (CHAMOMILLA, COFFEA CRUDA, AVENA SATIVA, NUX VOMICA, PASSIFLORA INCARNATA,) TABLET, ORALLY DISINTEGRATING [THE MAGNI COMPANY]2
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZSLEEP ASSIST (CHAMOMILLA, COFFEA CRUDA, AVENA SATIVA, NUX VOMICA, PASSIFLORA INCARNATA,) TABLET, ORALLY DISINTEGRATING [THE MAGNI COMPANY]2
PASSIFLORA INCARNATA FLOWERING TOPACTIVE MOIETYCLF5YFS11OSLEEP ASSIST (CHAMOMILLA, COFFEA CRUDA, AVENA SATIVA, NUX VOMICA, PASSIFLORA INCARNATA,) TABLET, ORALLY DISINTEGRATING [THE MAGNI COMPANY]2
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH13919SLEEP ASSIST (CHAMOMILLA, COFFEA CRUDA, AVENA SATIVA, NUX VOMICA, PASSIFLORA INCARNATA,) TABLET, ORALLY DISINTEGRATING [THE MAGNI COMPANY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USLEEP ASSIST (CHAMOMILLA, COFFEA CRUDA, AVENA SATIVA, NUX VOMICA, PASSIFLORA INCARNATA,) TABLET, ORALLY DISINTEGRATING [THE MAGNI COMPANY]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GSLEEP ASSIST (CHAMOMILLA, COFFEA CRUDA, AVENA SATIVA, NUX VOMICA, PASSIFLORA INCARNATA,) TABLET, ORALLY DISINTEGRATING [THE MAGNI COMPANY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SLEEP ASSIST (CHAMOMILLA, COFFEA CRUDA, AVENA SATIVA, NUX VOMICA, PASSIFLORA INCARNATA,) TABLET, ORALLY DISINTEGRATING [THE MAGNI COMPANY]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43689-0002-143689000201125 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (43689-0002-1) 2012-09-100000-00-00NoNoCurrent