FDA.reportPublic FDA data

Calm mind

Product NDC
76472-7015
11-digit product format
764727015
Labeler code
76472
Product ID
76472-7015_58ea2587-eaf5-ec4c-e063-6294a90a58b9
Type
HUMAN OTC DRUG
Nonproprietary name
Aconitum napellus 9C, Chamomilla 9C, Gelsemium sempervirens 9C, Ignatia amara 9C, Passiflora incarnata 3C, Stramonium 9C
Dosage form
SPRAY
Route
BUCCAL
Labeler
SEVENE USA
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2026-08-14
Substance
STRYCHNOS IGNATII SEED; MATRICARIA RECUTITA; PASSIFLORA INCARNATA TOP; GELSEMIUM SEMPERVIRENS ROOT; DATURA STRAMONIUM; ACONITUM NAPELLUS
Active strength
.1; .1; .1; .1; .1; .1 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Calm mind
Brand name suffix
Stress - Nervousness - Anxiety - Concentration
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STRYCHNOS IGNATII SEED.1 mg/100mL
MATRICARIA RECUTITA.1 mg/100mL
PASSIFLORA INCARNATA TOP.1 mg/100mL
GELSEMIUM SEMPERVIRENS ROOT.1 mg/100mL
DATURA STRAMONIUM.1 mg/100mL
ACONITUM NAPELLUS.1 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1NM3M2487KInternal UNII lookup
G0R4UBI2ZZInternal UNII lookup
CLF5YFS11OInternal UNII lookup
639KR60Q1QInternal UNII lookup
G6W4F0V8Z3Internal UNII lookup
U0NQ8555JDInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
551125a8-b6ed-f9f4-e063-6294a90a4c41Available on FDA.report

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
Calm mind Stress - Nervousness - Anxiety - ConcentrationACONITUM NAPELLUS 9C, CHAMOMILLA 9C, GELSEMIUM SEMPERVIRENS 9C, IGNATIA AMARA 9C, PASSIFLORA INCARNATA 3C, STRAMONIUM 9CSEVENE USA551125a8-b6ed-f9f4-e063-6294a90a4c412026-08-13WarningsExact identifier
ndc (product): 76472-7015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76472-7015-2764727015021 BOTTLE, SPRAY in 1 BOX (76472-7015-2) / 30 mL in 1 BOTTLE, SPRAY (76472-7015-1) 2026-08-14NoNoCurrent