Sprayology SleepEase

Product NDC
61096-0001
11-digit product format
610960001
Labeler code
61096
Product ID
61096-0001_5c97b252-9414-487d-8e67-6aab3520f36d
Type
HUMAN OTC DRUG
Nonproprietary name
Aquilegia vulgaris, Avena sativa, Chamomilla, Coffea cruda, Cypripedium pubescens, Humulus lupulus, Kali phosphoricum, Passiflora incarnata, Valeriana officinalis, Zincum metallicum
Dosage form
LIQUID
Route
ORAL
Labeler
Eight and Company
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2014-01-02
Marketing end
0000-00-00
Substance
AQUILEGIA VULGARIS; AVENA SATIVA FLOWERING TOP; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFOLUM ROOT; HOPS; POTASSIUM PHOSPHATE, DIBASIC; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN; ZINC
Active strength
1 [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct61096-0001IInactivated by FDA2026-08-17
excluded packagepackage61096-000161096-0001-2IInactivated by FDA2026-08-17

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 · 44 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 productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61096-0001-2IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61096-0001-2IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61096-0001-2IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61096-0001-2IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61096-0001-2IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61096-0001-2IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61096-0001-2IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61096-0001-2IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61096-0001-2IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61096-0001-2IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61096-0001-2IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61096-0001-2IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61096-0001-2IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61096-0001-2IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61096-0001-2IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage61096-0001-2IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage61096-0001-2IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage61096-0001-2IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage61096-0001-2IInactivated 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 packagepackage61096-0001-2IInactivated 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 packagepackage61096-0001-2IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage61096-0001-2EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61096-0001-22020-01-31C16284748780-19d75b9cf-f1d0-f424-e053-dadaa90a57ceSprayology SleepEase

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61096-0001-2Sprayology SleepEase41 mL in 1 BOTTLE, SPRAYLIQUID411
61096-0001-2Sprayology SleepEase1 in 1 CARTONLIQUID11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AQUILEGIA VULGARISACTIVE INGREDIENT8POZ61U1G2SPRAYOLOGY SLEEPEASE (AQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ZINCUM METALLICUM) LIQUID [EIGHT AND COMPANY]1
ARABICA COFFEE BEANACTIVE INGREDIENT3SW678MX72SPRAYOLOGY SLEEPEASE (AQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ZINCUM METALLICUM) LIQUID [EIGHT AND COMPANY]1
AVENA SATIVA FLOWERING TOPACTIVE INGREDIENTMA9CQJ3F7FSPRAYOLOGY SLEEPEASE (AQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ZINCUM METALLICUM) LIQUID [EIGHT AND COMPANY]1
CYPRIPEDIUM PARVIFOLUM ROOTACTIVE INGREDIENT21Y9GZ1LZASPRAYOLOGY SLEEPEASE (AQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ZINCUM METALLICUM) LIQUID [EIGHT AND COMPANY]1
HOPSACTIVE INGREDIENT01G73H6H83SPRAYOLOGY SLEEPEASE (AQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ZINCUM METALLICUM) LIQUID [EIGHT AND COMPANY]1
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZSPRAYOLOGY SLEEPEASE (AQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ZINCUM METALLICUM) LIQUID [EIGHT AND COMPANY]1
PASSIFLORA INCARNATA FLOWERING TOPACTIVE INGREDIENTCLF5YFS11OSPRAYOLOGY SLEEPEASE (AQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ZINCUM METALLICUM) LIQUID [EIGHT AND COMPANY]1
POTASSIUM PHOSPHATE, DIBASICACTIVE INGREDIENTCI71S98N1ZSPRAYOLOGY SLEEPEASE (AQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ZINCUM METALLICUM) LIQUID [EIGHT AND COMPANY]1
VALERIANACTIVE INGREDIENTJWF5YAW3QWSPRAYOLOGY SLEEPEASE (AQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ZINCUM METALLICUM) LIQUID [EIGHT AND COMPANY]1
ZINCACTIVE INGREDIENTJ41CSQ7QDSSPRAYOLOGY SLEEPEASE (AQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ZINCUM METALLICUM) LIQUID [EIGHT AND COMPANY]1
AQUILEGIA VULGARISACTIVE MOIETY8POZ61U1G2SPRAYOLOGY SLEEPEASE (AQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ZINCUM METALLICUM) LIQUID [EIGHT AND COMPANY]1
ARABICA COFFEE BEANACTIVE MOIETY3SW678MX72SPRAYOLOGY SLEEPEASE (AQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ZINCUM METALLICUM) LIQUID [EIGHT AND COMPANY]1
AVENA SATIVA FLOWERING TOPACTIVE MOIETYMA9CQJ3F7FSPRAYOLOGY SLEEPEASE (AQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ZINCUM METALLICUM) LIQUID [EIGHT AND COMPANY]1
CYPRIPEDIUM PARVIFOLUM ROOTACTIVE MOIETY21Y9GZ1LZASPRAYOLOGY SLEEPEASE (AQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ZINCUM METALLICUM) LIQUID [EIGHT AND COMPANY]1
HOPSACTIVE MOIETY01G73H6H83SPRAYOLOGY SLEEPEASE (AQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ZINCUM METALLICUM) LIQUID [EIGHT AND COMPANY]1
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZSPRAYOLOGY SLEEPEASE (AQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ZINCUM METALLICUM) LIQUID [EIGHT AND COMPANY]1
PASSIFLORA INCARNATA FLOWERING TOPACTIVE MOIETYCLF5YFS11OSPRAYOLOGY SLEEPEASE (AQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ZINCUM METALLICUM) LIQUID [EIGHT AND COMPANY]1
PHOSPHATE IONACTIVE MOIETYNK08V8K8HRSPRAYOLOGY SLEEPEASE (AQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ZINCUM METALLICUM) LIQUID [EIGHT AND COMPANY]1
VALERIANACTIVE MOIETYJWF5YAW3QWSPRAYOLOGY SLEEPEASE (AQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ZINCUM METALLICUM) LIQUID [EIGHT AND COMPANY]1
ZINCACTIVE MOIETYJ41CSQ7QDSSPRAYOLOGY SLEEPEASE (AQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ZINCUM METALLICUM) LIQUID [EIGHT AND COMPANY]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MSPRAYOLOGY SLEEPEASE (AQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ZINCUM METALLICUM) LIQUID [EIGHT AND COMPANY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSPRAYOLOGY SLEEPEASE (AQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ZINCUM METALLICUM) LIQUID [EIGHT AND COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RSPRAYOLOGY SLEEPEASE (AQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ZINCUM METALLICUM) LIQUID [EIGHT AND COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61096-0001SPRAYOLOGY SLEEPEASE (AQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ZINCUM METALLICUM) LIQUID [EIGHT AND COMPANY]1Legacy NDC, 2 package rows20140102_9ff35a9d-c330-42d1-859e-d75cf0f64463.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
61096-0001-26109600010241 mL in 1 BOTTLE, SPRAY41 mlHistorical