Quietude

Product NDC
0220-9314
11-digit product format
002209314
Labeler code
0220
Product ID
0220-9314_6b3ded40-9f0e-298f-e053-2991aa0a1d0a
Type
HUMAN OTC DRUG
Nonproprietary name
HYOSCYAMUS NIGER, NUTMEG, PASSIFLORA INCARNATA TOP, DATURA STRAMONIUM
Dosage form
TABLET
Route
ORAL
Labeler
Laboratoires Boiron
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2013-10-01
Marketing end
0000-00-00
Substance
HYOSCYAMUS NIGER; NUTMEG; PASSIFLORA INCARNATA TOP; DATURA STRAMONIUM
Active strength
3 [hp_C]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct0220-9314DDiscontinued by firm2026-10-05
excluded packagepackage0220-93140220-9314-04DDiscontinued by firm2026-10-05

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 · 20 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 packagepackage0220-9314-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0220-9314-04f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0220-9314-042ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0220-9314-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0220-9314-04cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0220-9314-04cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0220-9314-04302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0220-9314-04ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0220-9314-040efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0220-9314-04ad56d346431e…cc804d4bbf1e…

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
0220-9314-042023-11-29C16284748780-1f386c649-ece6-0266-e053-dadaa90a7c1aQuietude
0220-9314-042023-01-30C16284748780-1f386c649-ece6-0266-e053-dadaa90a7c1aQuietude

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DATURA STRAMONIUMACTIVE INGREDIENTG6W4F0V8Z3QUIETUDE (HYOSCYAMUS NIGER, NUTMEG, PASSIFLORA INCARNATA TOP, DATURA STRAMONIUM) TABLET [LABORATOIRES BOIRON]3
HYOSCYAMUS NIGERACTIVE INGREDIENT4WRK2153H3QUIETUDE (HYOSCYAMUS NIGER, NUTMEG, PASSIFLORA INCARNATA TOP, DATURA STRAMONIUM) TABLET [LABORATOIRES BOIRON]3
NUTMEGACTIVE INGREDIENTAEE24M3MQ9QUIETUDE (HYOSCYAMUS NIGER, NUTMEG, PASSIFLORA INCARNATA TOP, DATURA STRAMONIUM) TABLET [LABORATOIRES BOIRON]3
PASSIFLORA INCARNATA TOPACTIVE INGREDIENTCLF5YFS11OQUIETUDE (HYOSCYAMUS NIGER, NUTMEG, PASSIFLORA INCARNATA TOP, DATURA STRAMONIUM) TABLET [LABORATOIRES BOIRON]3
DATURA STRAMONIUMACTIVE MOIETYG6W4F0V8Z3QUIETUDE (HYOSCYAMUS NIGER, NUTMEG, PASSIFLORA INCARNATA TOP, DATURA STRAMONIUM) TABLET [LABORATOIRES BOIRON]3
HYOSCYAMUS NIGERACTIVE MOIETY4WRK2153H3QUIETUDE (HYOSCYAMUS NIGER, NUTMEG, PASSIFLORA INCARNATA TOP, DATURA STRAMONIUM) TABLET [LABORATOIRES BOIRON]3
NUTMEGACTIVE MOIETYAEE24M3MQ9QUIETUDE (HYOSCYAMUS NIGER, NUTMEG, PASSIFLORA INCARNATA TOP, DATURA STRAMONIUM) TABLET [LABORATOIRES BOIRON]3
PASSIFLORA INCARNATA TOPACTIVE MOIETYCLF5YFS11OQUIETUDE (HYOSCYAMUS NIGER, NUTMEG, PASSIFLORA INCARNATA TOP, DATURA STRAMONIUM) TABLET [LABORATOIRES BOIRON]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48QUIETUDE (HYOSCYAMUS NIGER, NUTMEG, PASSIFLORA INCARNATA TOP, DATURA STRAMONIUM) TABLET [LABORATOIRES BOIRON]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GQUIETUDE (HYOSCYAMUS NIGER, NUTMEG, PASSIFLORA INCARNATA TOP, DATURA STRAMONIUM) TABLET [LABORATOIRES BOIRON]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUIETUDE (HYOSCYAMUS NIGER, NUTMEG, PASSIFLORA INCARNATA TOP, DATURA STRAMONIUM) TABLET [LABORATOIRES BOIRON]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0220-9314-040022093140460 TABLET in 1 BOX (0220-9314-04) 60 tablet2013-10-010000-00-00NoNoCurrent