Sleep Now Remedy

Product NDC
53852-0009
11-digit product format
538520009
Labeler code
53852
Product ID
53852-0009_482be1cf-f0eb-4b47-b715-61cc0fb7119c
Type
HUMAN OTC DRUG
Nonproprietary name
avena sativa, camphora, coffea cruda, cypripedium pubescens, ignatia amara, passiflora incarnata, valeriana officinalis
Dosage form
LIQUID
Route
ORAL
Labeler
Living Well Remedies, LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2010-07-16
Marketing end
0000-00-00
Substance
AVENA SATIVA FLOWERING TOP; CAMPHOR (NATURAL); ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFOLUM ROOT; STRYCHNOS IGNATII SEED; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN
Active strength
10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL
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 productproduct53852-0009IInactivated by FDA2026-08-11
excluded packagepackage53852-000953852-0009-2IInactivated by FDA2026-08-11

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 · 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 packagepackage53852-0009-2IInactivated 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 packagepackage53852-0009-2IInactivated 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 packagepackage53852-0009-2IInactivated 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 packagepackage53852-0009-2IInactivated 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 packagepackage53852-0009-2IInactivated 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 packagepackage53852-0009-2IInactivated 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 packagepackage53852-0009-2IInactivated 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 packagepackage53852-0009-2IInactivated 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 packagepackage53852-0009-2IInactivated 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 packagepackage53852-0009-2IInactivated 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 packagepackage53852-0009-2IInactivated 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 packagepackage53852-0009-2IInactivated 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 packagepackage53852-0009-2IInactivated 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 packagepackage53852-0009-2IInactivated 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 packagepackage53852-0009-2IInactivated 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 packagepackage53852-0009-2IInactivated 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 packagepackage53852-0009-2IInactivated 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 packagepackage53852-0009-2IInactivated 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 packagepackage53852-0009-2IInactivated 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 packagepackage53852-0009-2IInactivated 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 packagepackage53852-0009-2IInactivated 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 packagepackage53852-0009-2EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53852-0009-22020-01-31C16284748780-19d75b9cf-e1cb-f424-e053-dadaa90a57ceSleep Now Remedy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53852-0009-2Sleep Now Remedy59 mL in 1 BOTTLE, SPRAYLIQUID591

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARABICA COFFEE BEANACTIVE INGREDIENT3SW678MX72SLEEP NOW REMEDY (AVENA SATIVA, CAMPHORA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, IGNATIA AMARA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [LIVING WELL REMEDIES, LLC]1
AVENA SATIVA FLOWERING TOPACTIVE INGREDIENTMA9CQJ3F7FSLEEP NOW REMEDY (AVENA SATIVA, CAMPHORA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, IGNATIA AMARA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [LIVING WELL REMEDIES, LLC]1
CAMPHOR (NATURAL)ACTIVE INGREDIENTN20HL7Q941SLEEP NOW REMEDY (AVENA SATIVA, CAMPHORA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, IGNATIA AMARA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [LIVING WELL REMEDIES, LLC]1
CYPRIPEDIUM PARVIFOLUM ROOTACTIVE INGREDIENT21Y9GZ1LZASLEEP NOW REMEDY (AVENA SATIVA, CAMPHORA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, IGNATIA AMARA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [LIVING WELL REMEDIES, LLC]1
PASSIFLORA INCARNATA FLOWERING TOPACTIVE INGREDIENTCLF5YFS11OSLEEP NOW REMEDY (AVENA SATIVA, CAMPHORA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, IGNATIA AMARA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [LIVING WELL REMEDIES, LLC]1
STRYCHNOS IGNATII SEEDACTIVE INGREDIENT1NM3M2487KSLEEP NOW REMEDY (AVENA SATIVA, CAMPHORA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, IGNATIA AMARA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [LIVING WELL REMEDIES, LLC]1
VALERIANACTIVE INGREDIENTJWF5YAW3QWSLEEP NOW REMEDY (AVENA SATIVA, CAMPHORA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, IGNATIA AMARA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [LIVING WELL REMEDIES, LLC]1
ARABICA COFFEE BEANACTIVE MOIETY3SW678MX72SLEEP NOW REMEDY (AVENA SATIVA, CAMPHORA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, IGNATIA AMARA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [LIVING WELL REMEDIES, LLC]1
AVENA SATIVA FLOWERING TOPACTIVE MOIETYMA9CQJ3F7FSLEEP NOW REMEDY (AVENA SATIVA, CAMPHORA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, IGNATIA AMARA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [LIVING WELL REMEDIES, LLC]1
CAMPHOR (NATURAL)ACTIVE MOIETYN20HL7Q941SLEEP NOW REMEDY (AVENA SATIVA, CAMPHORA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, IGNATIA AMARA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [LIVING WELL REMEDIES, LLC]1
CYPRIPEDIUM PARVIFOLUM ROOTACTIVE MOIETY21Y9GZ1LZASLEEP NOW REMEDY (AVENA SATIVA, CAMPHORA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, IGNATIA AMARA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [LIVING WELL REMEDIES, LLC]1
PASSIFLORA INCARNATA FLOWERING TOPACTIVE MOIETYCLF5YFS11OSLEEP NOW REMEDY (AVENA SATIVA, CAMPHORA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, IGNATIA AMARA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [LIVING WELL REMEDIES, LLC]1
STRYCHNOS IGNATII SEEDACTIVE MOIETY1NM3M2487KSLEEP NOW REMEDY (AVENA SATIVA, CAMPHORA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, IGNATIA AMARA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [LIVING WELL REMEDIES, LLC]1
VALERIANACTIVE MOIETYJWF5YAW3QWSLEEP NOW REMEDY (AVENA SATIVA, CAMPHORA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, IGNATIA AMARA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [LIVING WELL REMEDIES, LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSLEEP NOW REMEDY (AVENA SATIVA, CAMPHORA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, IGNATIA AMARA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [LIVING WELL REMEDIES, LLC]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4SLEEP NOW REMEDY (AVENA SATIVA, CAMPHORA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, IGNATIA AMARA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [LIVING WELL REMEDIES, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RSLEEP NOW REMEDY (AVENA SATIVA, CAMPHORA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, IGNATIA AMARA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [LIVING WELL REMEDIES, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53852-0009SLEEP NOW REMEDY (AVENA SATIVA, CAMPHORA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, IGNATIA AMARA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) LIQUID [LIVING WELL REMEDIES, LLC]1Legacy NDC, 1 package rows20141030_e94df5c4-d6da-4a89-958e-e84deb029ad0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
53852-0009-25385200090259 mL in 1 BOTTLE, SPRAY59 mlHistorical