FDA.reportPublic FDA data

MoodCalm

Manufacturer
Silver Star Brands | OHM Pharma, Inc.
Effective date
2025-01-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:29:59

Label at a glance#

ProductMoodCalm
Active ingredientLYCOSA TARANTULA, SODIUM SULFATE, HYOSCYAMUS NIGER LEAF, POTASSIUM PHOSPHATE, DIBASIC
Label structure10 sections

Indications and uses

Uses*: Homeopathic remedy for acute agittion, restlessness, or over excitement.

Dosage and administration

Directions: For all ages: Take 2 tablets every 30 minutes. Servings may be repeated as needed for up to 10 servings. Alternatively, for small babies, crush tablets and sprinkle onto tongue. Special instructions: Avoid strong mint-flavored candy.

Label contents#

Full prescribing information#

HPUS Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

HPUS Active Ingredients: Hyoscyamus 6C, Kali phos 6X, Nat sulphuricum 6X, Tarentula hisp 6C.

Uses*

INDICATIONS & USAGE SECTION

Uses*: Homeopathic remedy for acute agittion, restlessness, or over excitement.

Warnings

WARNINGS SECTION

Warnings: If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep this and all medicatoin out of reach of children. In case of overdose, ge medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions: For all ages: Take 2 tablets every 30 minutes. Servings may be repeated as needed for up to 10 servings. Alternatively, for small babies, crush tablets and sprinkle onto tongue.

Special instructions: Avoid strong mint-flavored candy.

OTHER SAFETY INFORMATION

Tamper resistant for your protection. Use only if safety seal is intact.

Contains no artificai flavors or colorants. No gluten added. Lactose-free.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Magnesium stearate, Maltodextrin, Sucrose.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medication out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use. Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

OTC - PURPOSE SECTION

Calms emotional outbursts & agitation and reduces mood swings. *

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MoodCalm TabletsMoodCalm Tablets

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68703-361-80MoodCalm180 in 1 BOTTLE, GLASSTABLET1803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68703-361MOODCALM (HYOSCYAMUS, KALI PHOS, NAT SULPHURICUM, TARENTULA HISP) TABLET [SILVER STAR BRANDS]3Current NDC, Legacy NDC, 1 package rows20250103_b7b33c9a-7c1d-58ac-e053-2995a90a9731.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68703-36168703-361-80

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
LYCOSA TARANTULA86M454L2TTACTIB
MALTODEXTRIN7CVR7L4A2DIACT
SUCROSEC151H8M554IACT
SODIUM SULFATE0YPR65R21JACTIB
HYOSCYAMUS NIGER LEAF32IT7G8BAWACTIB
MAGNESIUM STEARATE70097M6I30IACT
POTASSIUM PHOSPHATE, DIBASICCI71S98N1ZACTIB

Source Document#

Source XML

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
MoodCalmHYOSCYAMUS, KALI PHOS, NAT SULPHURICUM, TARENTULA HISPSilver Star Brandsb7b33c9a-7c1d-58ac-e053-2995a90a97312025-01-01WarningsExact identifier
ndc (package): 68703-361-80
ndc (product): 68703-361
ndc11 (package): 68703036180
spl id: 2ab1287c-c752-6a71-e063-6394a90a1cdd
spl set id: b7b33c9a-7c1d-58ac-e053-2995a90a9731

Reported adverse events (FAERS/openFDA)#

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