Insomnia

Product NDC
70163-0001
11-digit product format
701630001
Labeler code
70163
Product ID
70163-0001_0d37567f-e29d-4e20-9e93-cf8d93ad521c
Type
HUMAN OTC DRUG
Nonproprietary name
Arsenicum Album, Avena Sativa, Coffea Cruda, Kali Carbonicum, Magnesia Carbonica, Nux Vomica, Passiflora Incarnata, Sepia, Valeriana Officinalis
Dosage form
LIQUID
Route
ORAL
Labeler
Grato Holdings, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-11-23
Marketing end
2024-01-24
Substance
ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; ARABICA COFFEE BEAN; POTASSIUM CARBONATE; MAGNESIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA FLOWERING TOP; SEPIA OFFICINALIS JUICE; VALERIAN
Active strength
30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
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 productproduct70163-0001DDiscontinued by firm2026-08-11
excluded packagepackage70163-000170163-0001-1DDiscontinued 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 packagepackage70163-0001-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70163-0001-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70163-0001-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70163-0001-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70163-0001-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70163-0001-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70163-0001-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70163-0001-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70163-0001-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70163-0001-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70163-0001-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70163-0001-1557ba5c1ecfa…9c80585c8c6e…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARABICA COFFEE BEANACTIVE INGREDIENT3SW678MX72INSOMNIA HP (ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS) LIQUID [GRATO HOLDINGS, INC.]1
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HOINSOMNIA HP (ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS) LIQUID [GRATO HOLDINGS, INC.]1
AVENA SATIVA FLOWERING TOPACTIVE INGREDIENTMA9CQJ3F7FINSOMNIA HP (ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS) LIQUID [GRATO HOLDINGS, INC.]1
MAGNESIUM CARBONATEACTIVE INGREDIENT0E53J927NAINSOMNIA HP (ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS) LIQUID [GRATO HOLDINGS, INC.]1
PASSIFLORA INCARNATA FLOWERING TOPACTIVE INGREDIENTCLF5YFS11OINSOMNIA HP (ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS) LIQUID [GRATO HOLDINGS, INC.]1
POTASSIUM CARBONATEACTIVE INGREDIENTBQN1B9B9HAINSOMNIA HP (ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS) LIQUID [GRATO HOLDINGS, INC.]1
SEPIA OFFICINALIS JUICEACTIVE INGREDIENTQDL83WN8C2INSOMNIA HP (ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS) LIQUID [GRATO HOLDINGS, INC.]1
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH13919INSOMNIA HP (ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS) LIQUID [GRATO HOLDINGS, INC.]1
VALERIANACTIVE INGREDIENTJWF5YAW3QWINSOMNIA HP (ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS) LIQUID [GRATO HOLDINGS, INC.]1
ARABICA COFFEE BEANACTIVE MOIETY3SW678MX72INSOMNIA HP (ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS) LIQUID [GRATO HOLDINGS, INC.]1
ARSENIC CATION (3+)ACTIVE MOIETYC96613F5AVINSOMNIA HP (ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS) LIQUID [GRATO HOLDINGS, INC.]1
AVENA SATIVA FLOWERING TOPACTIVE MOIETYMA9CQJ3F7FINSOMNIA HP (ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS) LIQUID [GRATO HOLDINGS, INC.]1
CARBONATE IONACTIVE MOIETY7UJQ5OPE7DINSOMNIA HP (ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS) LIQUID [GRATO HOLDINGS, INC.]1
PASSIFLORA INCARNATA FLOWERING TOPACTIVE MOIETYCLF5YFS11OINSOMNIA HP (ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS) LIQUID [GRATO HOLDINGS, INC.]1
SEPIA OFFICINALIS JUICEACTIVE MOIETYQDL83WN8C2INSOMNIA HP (ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS) LIQUID [GRATO HOLDINGS, INC.]1
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH13919INSOMNIA HP (ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS) LIQUID [GRATO HOLDINGS, INC.]1
VALERIANACTIVE MOIETYJWF5YAW3QWINSOMNIA HP (ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS) LIQUID [GRATO HOLDINGS, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MINSOMNIA HP (ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS) LIQUID [GRATO HOLDINGS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RINSOMNIA HP (ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS) LIQUID [GRATO HOLDINGS, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70163-0001-17016300010130 mL in 1 BOTTLE, DROPPER (70163-0001-1) 30 ml2016-10-142024-01-24NoNoCurrent