Home NDC 50181-0080-1 Serene Sleep
Product NDC 50181-0080
Requested package NDC 50181-0080-1
11-digit product format 501810080
Labeler code 50181
Product ID 50181-0080_5b0d0301-c85f-4047-960f-ac9c150d827c
Type HUMAN OTC DRUG
Nonproprietary name Eschscholtzia Californica, Chamomilla, Cina, Coffea Cruda, Nux Vomica, Passiflora Incarnata, Pulsatilla (Pratensis), Ignatia Amara, Kali Phosphoricum, Rhus Tox
Dosage form SPRAY
Route ORAL
Labeler The Wellness Center for Research a
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2022-02-14
Marketing end 2027-03-22
Substance ARABICA COFFEE BEAN; ARTEMISIA CINA PRE-FLOWERING TOP; DIBASIC POTASSIUM PHOSPHATE; ESCHSCHOLZIA CALIFORNICA WHOLE; MATRICARIA CHAMOMILLA WHOLE; PASSIFLORA INCARNATA FLOWERING TOP; PULSATILLA PRATENSIS WHOLE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF
Active strength 6; 6; 30; 3; 3; 6; 6; 30; 6; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
Pharmacologic classes Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag No
Current FDA listing Yes 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 · 13 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Additional Listing Data#
Finished product Yes
Brand name base Serene Sleep Active Ingredients# Ingredient, Strength table Ingredient Strength ESCHSCHOLZIA CALIFORNICA WHOLE 6 [hp_C]/mL MATRICARIA CHAMOMILLA WHOLE 6 [hp_C]/mL ARTEMISIA CINA PRE-FLOWERING TOP 30 [hp_C]/mL ARABICA COFFEE BEAN 3 [hp_C]/mL STRYCHNOS NUX-VOMICA SEED 3 [hp_C]/mL PASSIFLORA INCARNATA FLOWERING TOP 6 [hp_C]/mL PULSATILLA PRATENSIS WHOLE 6 [hp_C]/mL STRYCHNOS IGNATII SEED 30 [hp_C]/mL DIBASIC POTASSIUM PHOSPHATE 6 [hp_C]/mL TOXICODENDRON PUBESCENS LEAF 30 [hp_C]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 10 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 50181-0080-1 Serene Sleep 30 mL in 1 BOTTLE, SPRAY SPRAY 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50181-0080 SERENE SLEEP (ESCHSCHOLTZIA CALIFORNICA, CHAMOMILLA, CINA, COFFEA CRUDA, NUX VOMICA, PASSIFLORA INCARNATA, PULSATILLA (PRATENSIS), IGNATIA AMARA, KALI PHOSPHORICUM, RHUS TOX) SPRAY [THE WELLNESS CENTER FOR RESEARCH A] 1 Current NDC, Legacy NDC, 1 package rows 20220215_2d5bbd0d-9b50-45ce-aa23-05bd05b54645.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Serene Sleep ESCHSCHOLTZIA CALIFORNICA, CHAMOMILLA, CINA, COFFEA CRUDA, NUX VOMICA, PASSIFLORA INCARNATA, PULSATILLA (PRATENSIS), IGNATIA AMARA, KALI PHOSPHORICUM, RHUS TOX The Wellness Center for Research a 2d5bbd0d-9b50-45ce-aa23-05bd05b54645 2025-06-06 Warnings Exact identifier ndc (package): 50181-0080-1 ndc (product): 50181-0080 ndc11 (package): 50181008001
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50181-0080-1 50181008001 30 mL in 1 BOTTLE, SPRAY (50181-0080-1) 30 ml 2022-02-14 2027-03-22 No No Current