Stress and Insomnia

Product NDC
69607-0011
11-digit product format
696070011
Labeler code
69607
Product ID
69607-0011_ca2f199b-a1b3-4da2-8f62-f72a81fc222d
Type
HUMAN OTC DRUG
Nonproprietary name
Avena Sativa, Chamomilla , Humulus Lupulus, Passiflora Incarnata
Dosage form
TABLET
Route
ORAL
Labeler
Biovea
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-07-06
Marketing end
2021-10-20
Substance
AVENA SATIVA FLOWERING TOP; MATRICARIA RECUTITA; HOPS; PASSIFLORA INCARNATA FLOWERING TOP
Active strength
3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct69607-0011DDiscontinued by firm2026-08-11
excluded packagepackage69607-001169607-0011-1DDiscontinued by firm2026-08-11

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69607-0011-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69607-0011-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69607-0011-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69607-0011-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69607-0011-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69607-0011-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69607-0011-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69607-0011-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69607-0011-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69607-0011-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69607-0011-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69607-0011-1557ba5c1ecfa…9c80585c8c6e…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVENA SATIVA FLOWERING TOPACTIVE INGREDIENTMA9CQJ3F7FSTRESS AND INSOMNIA (AVENA SATIVA, CHAMOMILLA , HUMULUS LUPULUS, PASSIFLORA INCARNATA) TABLET [BIOVEA]1
HOPSACTIVE INGREDIENT01G73H6H83STRESS AND INSOMNIA (AVENA SATIVA, CHAMOMILLA , HUMULUS LUPULUS, PASSIFLORA INCARNATA) TABLET [BIOVEA]1
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZSTRESS AND INSOMNIA (AVENA SATIVA, CHAMOMILLA , HUMULUS LUPULUS, PASSIFLORA INCARNATA) TABLET [BIOVEA]1
PASSIFLORA INCARNATA FLOWERING TOPACTIVE INGREDIENTCLF5YFS11OSTRESS AND INSOMNIA (AVENA SATIVA, CHAMOMILLA , HUMULUS LUPULUS, PASSIFLORA INCARNATA) TABLET [BIOVEA]1
AVENA SATIVA FLOWERING TOPACTIVE MOIETYMA9CQJ3F7FSTRESS AND INSOMNIA (AVENA SATIVA, CHAMOMILLA , HUMULUS LUPULUS, PASSIFLORA INCARNATA) TABLET [BIOVEA]1
HOPSACTIVE MOIETY01G73H6H83STRESS AND INSOMNIA (AVENA SATIVA, CHAMOMILLA , HUMULUS LUPULUS, PASSIFLORA INCARNATA) TABLET [BIOVEA]1
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZSTRESS AND INSOMNIA (AVENA SATIVA, CHAMOMILLA , HUMULUS LUPULUS, PASSIFLORA INCARNATA) TABLET [BIOVEA]1
PASSIFLORA INCARNATA FLOWERING TOPACTIVE MOIETYCLF5YFS11OSTRESS AND INSOMNIA (AVENA SATIVA, CHAMOMILLA , HUMULUS LUPULUS, PASSIFLORA INCARNATA) TABLET [BIOVEA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USTRESS AND INSOMNIA (AVENA SATIVA, CHAMOMILLA , HUMULUS LUPULUS, PASSIFLORA INCARNATA) TABLET [BIOVEA]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GSTRESS AND INSOMNIA (AVENA SATIVA, CHAMOMILLA , HUMULUS LUPULUS, PASSIFLORA INCARNATA) TABLET [BIOVEA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30STRESS AND INSOMNIA (AVENA SATIVA, CHAMOMILLA , HUMULUS LUPULUS, PASSIFLORA INCARNATA) TABLET [BIOVEA]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69607-0011-169607001101100 TABLET in 1 BOTTLE (69607-0011-1) 100 tablet2015-07-062021-10-20NoNoCurrent