Home NDC 69631-0001 Harmony Slumber
Product NDC 69631-0001
11-digit product format 696310001
Labeler code 69631
Product ID 69631-0001_5e15748d-a92f-4ea0-a21f-a58e2424b1ac
Type HUMAN OTC DRUG
Nonproprietary name Avena sativa, Chamomilla, Cypripedium pubescens, Daphne indica, Humulus lupulus, Hyoscyamus niger, kali bromatum, Kali phosphoricum, Lithium muriaticum, Passiflora incarnata, Scutellaria lateriflora, Stramonium, Succinum, Sumbul, Valeriana officinalis, Xanthoxylum fraxineum, Ferrum phosphoricum, Lecithin, Manganum phosphoricum, Arsenicum album, Coffea cruda, Ignatia amara, Nux moschata, agaricus muscarius, Belladonna, Cocculus indicus, Helleborus niger, Jequirity, Melissa officinalis, Viburnum opulus
Dosage form LIQUID
Route ORAL
Labeler Life Harmony Energies, LLC.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2015-10-08
Marketing end 0000-00-00
Substance AVENA SATIVA FLOWERING TOP; MATRICARIA RECUTITA; CYPRIPEDIUM PARVIFOLUM ROOT; DAPHNE ODORA BARK; HOPS; HYOSCYAMUS NIGER; POTASSIUM BROMIDE; POTASSIUM PHOSPHATE, DIBASIC; LITHIUM CHLORIDE; PASSIFLORA INCARNATA FLOWERING TOP; SCUTELLARIA LATERIFLORA; DATURA STRAMONIUM; AMBER; FERULA SUMBUL ROOT; VALERIAN; ZANTHOXYLUM AMERICANUM BARK; FERROSOFERRIC PHOSPHATE; EGG PHOSPHOLIPIDS; MANGANESE PHOSPHATE, DIBASIC; ARSENIC TRIOXIDE; ARABICA COFFEE BEAN; STRYCHNOS IGNATII SEED; NUTMEG; AMANITA MUSCARIA FRUITING BODY; ATROPA BELLADONNA; ANAMIRTA COCCULUS SEED; HELLEBORUS NIGER ROOT; ABRUS PRECATORIUS SEED; MELISSA OFFICINALIS; VIBURNUM OPULUS BARK
Active strength 6 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record 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 date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69631-0001-2 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 69631-0001-2 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 69631-0001-2 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 69631-0001-2 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 69631-0001-2 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 69631-0001-2 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 69631-0001-2 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 69631-0001-2 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69631-0001-2 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 69631-0001-2 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 69631-0001-2 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 69631-0001-2 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 69631-0001-2 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 69631-0001-2 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 69631-0001-2 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 69631-0001-2 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 69631-0001-2 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 69631-0001-2 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 69631-0001-2 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 69631-0001-2 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 69631-0001-2 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 69631-0001-2 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69631-0001-2 Harmony Slumber 60 mL in 1 BOTTLE, SPRAY LIQUID 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69631-0001 HARMONY SLUMBER (AVENA SATIVA, CHAMOMILLA, CYPRIPEDIUM PUBESCENS, DAPHNE INDICA, HUMULUS LUPULUS, HYOSCYAMUS NIGER, KALI BROMATUM, KALI PHOSPHORICUM, LITHIUM MURIATICUM, PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, STRAMONIUM, SUCCINUM, SUMBUL, VALERIANA OFFICINALIS, XANTHOXYLUM FRAXINEUM, FERRUM PHOSPHORICUM, LECITHIN, MANGANUM PHOSPHORICUM, ARSENICUM ALBUM, COFFEA CRUDA, IGNATIA AMARA, NUX MOSCHATA, AGARICUS MUSCARIUS, BELLADONNA, COCCULUS INDICUS, HELLEBORUS NIGER, JEQUIRITY, MELISSA OFFICINALIS, VIBURNUM OPULUS) LIQUID [LIFE HARMONY ENERGIES, LLC.] 1 Legacy NDC, 1 package rows 20160304_7553ccad-c798-4430-8179-9b908eaceea1.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 69631-0001-2 69631000102 60 mL in 1 BOTTLE, SPRAY 60 ml Historical