Serene Sleep
- Product NDC
- 50181-0080
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Serene Sleep
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ARABICA COFFEE BEAN | 6 [hp_C]/mL |
| ARTEMISIA CINA PRE-FLOWERING TOP | 6 [hp_C]/mL |
| DIBASIC POTASSIUM PHOSPHATE | 30 [hp_C]/mL |
| ESCHSCHOLZIA CALIFORNICA WHOLE | 3 [hp_C]/mL |
| MATRICARIA CHAMOMILLA WHOLE | 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 |
| STRYCHNOS NUX-VOMICA SEED | 6 [hp_C]/mL |
| TOXICODENDRON PUBESCENS LEAF | 30 [hp_C]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3SW678MX72, 28M1820ACT, CI71S98N1Z, 9315HN272X, G0R4UBI2ZZ, CLF5YFS11O, 8E272251DI, 1NM3M2487K, 269XH13919, 6IO182RP7A |
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 |
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 |