Neuro Calming Formula

Product NDC
83027-0013
11-digit product format
830270013
Labeler code
83027
Product ID
83027-0013_d3ac609b-8199-48d9-8275-4ea9bfa08772
Type
HUMAN OTC DRUG
Nonproprietary name
Avena Sativa, Humulus Lupulus, Passiflora Incarnata, Valeriana Officinalis, Ignatia Amara, Scutellaria Lateriflora, Zincum Metallicum
Dosage form
SPRAY
Route
ORAL
Labeler
Nutritional Specialties, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-02-21
Substance
AVENA SATIVA FLOWERING TOP; HOPS; PASSIFLORA INCARNATA FLOWERING TOP; SCUTELLARIA LATERIFLORA WHOLE; STRYCHNOS IGNATII SEED; VALERIAN; ZINC
Active strength
2; 2; 2; 6; 6; 2; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
MA9CQJ3F7FAVENA SATIVA FLOWERING TOPAVENA SATIVA FLOWERING TOP
01G73H6H83HOPSHOPS
CLF5YFS11OPASSIFLORA INCARNATA FLOWERING TOPPASSIFLORA INCARNATA FLOWERING TOP
1NM3M2487KSTRYCHNOS IGNATII SEEDSTRYCHNOS IGNATII SEED
JWF5YAW3QWVALERIAN8057-49-6VALERIAN
J41CSQ7QDSZINC7440-66-6ZINC

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83027-0013-18302700130160 mL in 1 BOTTLE, SPRAY (83027-0013-1) 60 ml2023-02-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
DRUG FACTS:Nutritional Specialties, Inc.2025-10-08HUMAN OTC DRUG LABEL4
DRUG FACTS:Nutritional Specialties, Inc.2024-09-11HUMAN OTC DRUG LABEL3