FDA.reportPublic FDA data

soothe and sleep

Product NDC
69779-018
Requested package NDC
69779-018-02
11-digit product format
697790018
Labeler code
69779
Product ID
69779-018_d66f7484-dd48-333f-e053-2995a90a37ca
Type
HUMAN OTC DRUG
Nonproprietary name
Aesculus hippocastanum, flos, Chamomilla, Ferr Phos, Helianthemum nummularium, flos, mimulus guttatus, flos, Nat Mur, Nat Phos, Nat Sulph, Phosphorus, Verbena officinalis, flos
Dosage form
SPRAY
Route
ORAL; TOPICAL
Labeler
Siddha Flower Essences LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2017-03-01
Marketing end
0000-00-00
Substance
AESCULUS HIPPOCASTANUM FLOWER; FERROSOFERRIC PHOSPHATE; HELIANTHEMUM NUMMULARIUM FLOWER; MATRICARIA RECUTITA; MIMULUS GUTTATUS FLOWERING TOP; PHOSPHORUS; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; VERBENA OFFICINALIS FLOWERING TOP
Active strength
5 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_C]/29.6mL; [hp_X]/29.6mL; [hp_C]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL
Pharmacologic classes
Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69779-01869779-018-02DDiscontinued 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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
69779-018-012026-01-01Drug Facts
69779-018-022026-01-01Drug Facts
69779-018-012024-01-30Drug Facts
69779-018-022024-01-30Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AESCULUS HIPPOCASTANUM FLOWERACTIVE INGREDIENTKK0Z92II8MSOOTHE AND SLEEP (AESCULUS HIPPOCASTANUM, FLOS, CHAMOMILLA, FERR PHOS, HELIANTHEMUM NUMMULARIUM, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, NAT SULPH, PHOSPHORUS, VERBENA OFFICINALIS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
FERROSOFERRIC PHOSPHATEACTIVE INGREDIENT91GQH8I5F7SOOTHE AND SLEEP (AESCULUS HIPPOCASTANUM, FLOS, CHAMOMILLA, FERR PHOS, HELIANTHEMUM NUMMULARIUM, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, NAT SULPH, PHOSPHORUS, VERBENA OFFICINALIS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
HELIANTHEMUM NUMMULARIUM FLOWERACTIVE INGREDIENT51BRR32WPPSOOTHE AND SLEEP (AESCULUS HIPPOCASTANUM, FLOS, CHAMOMILLA, FERR PHOS, HELIANTHEMUM NUMMULARIUM, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, NAT SULPH, PHOSPHORUS, VERBENA OFFICINALIS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZSOOTHE AND SLEEP (AESCULUS HIPPOCASTANUM, FLOS, CHAMOMILLA, FERR PHOS, HELIANTHEMUM NUMMULARIUM, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, NAT SULPH, PHOSPHORUS, VERBENA OFFICINALIS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
MIMULUS GUTTATUS FLOWERING TOPACTIVE INGREDIENT192426I5JUSOOTHE AND SLEEP (AESCULUS HIPPOCASTANUM, FLOS, CHAMOMILLA, FERR PHOS, HELIANTHEMUM NUMMULARIUM, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, NAT SULPH, PHOSPHORUS, VERBENA OFFICINALIS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
PHOSPHORUSACTIVE INGREDIENT27YLU75U4WSOOTHE AND SLEEP (AESCULUS HIPPOCASTANUM, FLOS, CHAMOMILLA, FERR PHOS, HELIANTHEMUM NUMMULARIUM, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, NAT SULPH, PHOSPHORUS, VERBENA OFFICINALIS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XSOOTHE AND SLEEP (AESCULUS HIPPOCASTANUM, FLOS, CHAMOMILLA, FERR PHOS, HELIANTHEMUM NUMMULARIUM, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, NAT SULPH, PHOSPHORUS, VERBENA OFFICINALIS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEACTIVE INGREDIENT70WT22SF4BSOOTHE AND SLEEP (AESCULUS HIPPOCASTANUM, FLOS, CHAMOMILLA, FERR PHOS, HELIANTHEMUM NUMMULARIUM, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, NAT SULPH, PHOSPHORUS, VERBENA OFFICINALIS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
SODIUM SULFATEACTIVE INGREDIENT0YPR65R21JSOOTHE AND SLEEP (AESCULUS HIPPOCASTANUM, FLOS, CHAMOMILLA, FERR PHOS, HELIANTHEMUM NUMMULARIUM, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, NAT SULPH, PHOSPHORUS, VERBENA OFFICINALIS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
VERBENA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT311PNK9CDZSOOTHE AND SLEEP (AESCULUS HIPPOCASTANUM, FLOS, CHAMOMILLA, FERR PHOS, HELIANTHEMUM NUMMULARIUM, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, NAT SULPH, PHOSPHORUS, VERBENA OFFICINALIS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
AESCULUS HIPPOCASTANUM FLOWERACTIVE MOIETYKK0Z92II8MSOOTHE AND SLEEP (AESCULUS HIPPOCASTANUM, FLOS, CHAMOMILLA, FERR PHOS, HELIANTHEMUM NUMMULARIUM, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, NAT SULPH, PHOSPHORUS, VERBENA OFFICINALIS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
FERROSOFERRIC PHOSPHATEACTIVE MOIETY91GQH8I5F7SOOTHE AND SLEEP (AESCULUS HIPPOCASTANUM, FLOS, CHAMOMILLA, FERR PHOS, HELIANTHEMUM NUMMULARIUM, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, NAT SULPH, PHOSPHORUS, VERBENA OFFICINALIS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
HELIANTHEMUM NUMMULARIUM FLOWERACTIVE MOIETY51BRR32WPPSOOTHE AND SLEEP (AESCULUS HIPPOCASTANUM, FLOS, CHAMOMILLA, FERR PHOS, HELIANTHEMUM NUMMULARIUM, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, NAT SULPH, PHOSPHORUS, VERBENA OFFICINALIS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZSOOTHE AND SLEEP (AESCULUS HIPPOCASTANUM, FLOS, CHAMOMILLA, FERR PHOS, HELIANTHEMUM NUMMULARIUM, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, NAT SULPH, PHOSPHORUS, VERBENA OFFICINALIS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
MIMULUS GUTTATUS FLOWERING TOPACTIVE MOIETY192426I5JUSOOTHE AND SLEEP (AESCULUS HIPPOCASTANUM, FLOS, CHAMOMILLA, FERR PHOS, HELIANTHEMUM NUMMULARIUM, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, NAT SULPH, PHOSPHORUS, VERBENA OFFICINALIS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
PHOSPHORUSACTIVE MOIETY27YLU75U4WSOOTHE AND SLEEP (AESCULUS HIPPOCASTANUM, FLOS, CHAMOMILLA, FERR PHOS, HELIANTHEMUM NUMMULARIUM, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, NAT SULPH, PHOSPHORUS, VERBENA OFFICINALIS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
SODIUM CATIONACTIVE MOIETYLYR4M0NH37SOOTHE AND SLEEP (AESCULUS HIPPOCASTANUM, FLOS, CHAMOMILLA, FERR PHOS, HELIANTHEMUM NUMMULARIUM, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, NAT SULPH, PHOSPHORUS, VERBENA OFFICINALIS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
SODIUM SULFATE ANHYDROUSACTIVE MOIETY36KCS0R750SOOTHE AND SLEEP (AESCULUS HIPPOCASTANUM, FLOS, CHAMOMILLA, FERR PHOS, HELIANTHEMUM NUMMULARIUM, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, NAT SULPH, PHOSPHORUS, VERBENA OFFICINALIS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
VERBENA OFFICINALIS FLOWERING TOPACTIVE MOIETY311PNK9CDZSOOTHE AND SLEEP (AESCULUS HIPPOCASTANUM, FLOS, CHAMOMILLA, FERR PHOS, HELIANTHEMUM NUMMULARIUM, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, NAT SULPH, PHOSPHORUS, VERBENA OFFICINALIS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
LICORICEINACTIVE INGREDIENT61ZBX54883SOOTHE AND SLEEP (AESCULUS HIPPOCASTANUM, FLOS, CHAMOMILLA, FERR PHOS, HELIANTHEMUM NUMMULARIUM, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, NAT SULPH, PHOSPHORUS, VERBENA OFFICINALIS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
MATRICARIA RECUTITA FLOWERING TOPINACTIVE INGREDIENT3VNC7T6Z02SOOTHE AND SLEEP (AESCULUS HIPPOCASTANUM, FLOS, CHAMOMILLA, FERR PHOS, HELIANTHEMUM NUMMULARIUM, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, NAT SULPH, PHOSPHORUS, VERBENA OFFICINALIS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
MELISSA OFFICINALIS FLOWERING TOPINACTIVE INGREDIENT5JQG17B06JSOOTHE AND SLEEP (AESCULUS HIPPOCASTANUM, FLOS, CHAMOMILLA, FERR PHOS, HELIANTHEMUM NUMMULARIUM, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, NAT SULPH, PHOSPHORUS, VERBENA OFFICINALIS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
VALERIANINACTIVE INGREDIENTJWF5YAW3QWSOOTHE AND SLEEP (AESCULUS HIPPOCASTANUM, FLOS, CHAMOMILLA, FERR PHOS, HELIANTHEMUM NUMMULARIUM, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, NAT SULPH, PHOSPHORUS, VERBENA OFFICINALIS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RSOOTHE AND SLEEP (AESCULUS HIPPOCASTANUM, FLOS, CHAMOMILLA, FERR PHOS, HELIANTHEMUM NUMMULARIUM, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, NAT SULPH, PHOSPHORUS, VERBENA OFFICINALIS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69779-018SOOTHE AND SLEEP (AESCULUS HIPPOCASTANUM, FLOS, CHAMOMILLA, FERR PHOS, HELIANTHEMUM NUMMULARIUM, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, NAT SULPH, PHOSPHORUS, VERBENA OFFICINALIS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]3Legacy NDC20220126_1bec3bf3-82e4-4eb4-8c7f-d0105b88b575.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69779-018-02697790018021 BOTTLE in 1 CARTON (69779-018-02) > 7.5 mL in 1 BOTTLE1 bottle2017-04-030000-00-00NoNoCurrent