FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Neuro Calming Formula
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVENA SATIVA FLOWERING TOP2 [hp_X]/mL
HOPS2 [hp_X]/mL
PASSIFLORA INCARNATA FLOWERING TOP2 [hp_X]/mL
VALERIAN6 [hp_X]/mL
STRYCHNOS IGNATII SEED6 [hp_X]/mL
SCUTELLARIA LATERIFLORA WHOLE2 [hp_X]/mL
ZINC12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MA9CQJ3F7FInternal UNII lookup
01G73H6H83Internal UNII lookup
CLF5YFS11OInternal UNII lookup
JWF5YAW3QWInternal UNII lookup
1NM3M2487KInternal UNII lookup
7BP4DH5PDCInternal UNII lookup
J41CSQ7QDSInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ff9b8811-1883-42bc-bcf4-7b390237a619Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83027-0013-1Neuro Calming Formula60 mL in 1 BOTTLE, SPRAYSPRAY604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83027-0013NEURO CALMING FORMULA (AVENA SATIVA, HUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, IGNATIA AMARA, SCUTELLARIA LATERIFLORA, ZINCUM METALLICUM) SPRAY [NUTRITIONAL SPECIALTIES, INC.]3Current NDC, 1 package rows20240912_ff9b8811-1883-42bc-bcf4-7b390237a619.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neuro Calming FormulaAVENA SATIVA, HUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, IGNATIA AMARA, SCUTELLARIA LATERIFLORA, ZINCUM METALLICUMNutritional Specialties, Inc.ff9b8811-1883-42bc-bcf4-7b390237a6192025-10-08WarningsExact identifier
ndc (product): 83027-0013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83027-0013-18302700130160 mL in 1 BOTTLE, SPRAY (83027-0013-1) 60 ml2023-02-21NoNoCurrent