Calm Anxiety and Stress

Product NDC
70558-0010
11-digit product format
705580010
Labeler code
70558
Product ID
70558-0010_706ae87e-d4ae-4132-a930-23598e0fa7fe
Type
HUMAN OTC DRUG
Nonproprietary name
Clematis Vitalba, Flos, Helianthemum Nummularium, Flos, Impatiens Glandulifera, Flos, Ornithogalum Umbellatum, Flos, Passiflora Incarnata, Angelica Sinensis, Argentum Nitricum, Cacao, Lithium Carbonicum, Prunus Cerasifera, Flos, Valeriana Officinalis, Piper Methysticum, Glandula Suprarenalis Suis, Aconitum Napellus, Anacardium Orientale, Arsenicum Album, Calcarea Carbonica, Cocculus Indicus, Ignatia Amara, Gelsemium Sempervirens
Dosage form
LIQUID
Route
ORAL
Labeler
Pro Weight Loss Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-07-29
Substance
CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PASSIFLORA INCARNATA FLOWERING TOP; ANGELICA SINENSIS ROOT; SILVER NITRATE; COCOA; LITHIUM CARBONATE; PRUNUS CERASIFERA FLOWER; VALERIAN; MACROPIPER METHYSTICUM ROOT; SUS SCROFA ADRENAL GLAND; ACONITUM NAPELLUS WHOLE; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ANAMIRTA COCCULUS SEED; STRYCHNOS IGNATII SEED; GELSEMIUM SEMPERVIRENS ROOT
Active strength
3; 3; 3; 3; 3; 6; 6; 6; 6; 6; 6; 7; 8; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [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], Increased Histamine Release [PE], Mood Stabilizer [EPC], Non-Standardized Food Allergenic Extract [EPC], Plant Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
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 Anxiety and Stress
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLEMATIS VITALBA FLOWER3 [hp_X]/mL
HELIANTHEMUM NUMMULARIUM FLOWER3 [hp_X]/mL
IMPATIENS GLANDULIFERA FLOWER3 [hp_X]/mL
ORNITHOGALUM UMBELLATUM FLOWERING TOP3 [hp_X]/mL
PASSIFLORA INCARNATA FLOWERING TOP3 [hp_X]/mL
ANGELICA SINENSIS ROOT6 [hp_X]/mL
SILVER NITRATE6 [hp_X]/mL
COCOA6 [hp_X]/mL
LITHIUM CARBONATE6 [hp_X]/mL
PRUNUS CERASIFERA FLOWER6 [hp_X]/mL
VALERIAN6 [hp_X]/mL
MACROPIPER METHYSTICUM ROOT7 [hp_X]/mL
SUS SCROFA ADRENAL GLAND8 [hp_X]/mL
ACONITUM NAPELLUS WHOLE12 [hp_X]/mL
SEMECARPUS ANACARDIUM JUICE12 [hp_X]/mL
ARSENIC TRIOXIDE12 [hp_X]/mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]/mL
ANAMIRTA COCCULUS SEED12 [hp_X]/mL
STRYCHNOS IGNATII SEED12 [hp_X]/mL
GELSEMIUM SEMPERVIRENS ROOT12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 20 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7SCP4N87CIInternal UNII lookup
51BRR32WPPInternal UNII lookup
AJU5O1A5ZVInternal UNII lookup
CZD6M4PY4BInternal UNII lookup
CLF5YFS11OInternal UNII lookup
B66F4574UGInternal UNII lookup
95IT3W8JZEInternal UNII lookup
D9108TZ9KGInternal UNII lookup
2BMD2GNA4VInternal UNII lookup
0KD7R09EASInternal UNII lookup
JWF5YAW3QWInternal UNII lookup
BOW48C81XPInternal UNII lookup
398IYQ16YVInternal UNII lookup
U0NQ8555JDInternal UNII lookup
Y0F0BU8RDUInternal UNII lookup
S7V92P67HOInternal UNII lookup
2E32821G6IInternal UNII lookup
810258W28UInternal UNII lookup
1NM3M2487KInternal UNII lookup
639KR60Q1QInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f5fb248f-e078-4dba-9bee-be0e803b6a13Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3053bb1-353b-4a0b-bca5-28fe7228957cProduct name220250124
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
8ce6e144-236f-b7be-f690-f06e0c8c6bd3Product name220170725
f09af6ee-c6dd-d0ce-77ad-93508bcdacedProduct name420161205
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70558-0010-1Calm Anxiety and Stress30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70558-0010CALM ANXIETY AND STRESS (CLEMATIS VITALBA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, ORNITHOGALUM UMBELLATUM, FLOS, PASSIFLORA INCARNATA, ANGELICA SINENSIS, ARGENTUM NITRICUM, CACAO, LITHIUM CARBONICUM, PRUNUS CERASIFERA, FLOS, VALERIANA OFFICINALIS, PIPER METHYSTICUM, GLANDULA SUPRARENALIS SUIS, ACONITUM NAPELLUS, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, CALCAREA CARBONICA, COCCULUS INDICUS, IGNATIA AMARA, GELSEMIUM SEMPERVIRENS) LIQUID [PRO WEIGHT LOSS INC.]2Current NDC, Legacy NDC, 1 package rows20230111_f5fb248f-e078-4dba-9bee-be0e803b6a13.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
Calm Anxiety and StressCLEMATIS VITALBA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, ORNITHOGALUM UMBELLATUM, FLOS, PASSIFLORA INCARNATA, ANGELICA SINENSIS, ARGENTUM NITRICUM, CACAO, LITHIUM CARBONICUM, PRUNUS CERASIFERA, FLOS, VALERIANA OFFICINALIS, PIPER METHYSTICUM, GLANDULA SUPRARENALIS SUIS, ACONITUM NAPELLUS, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, CALCAREA CARBONICA, COCCULUS INDICUS, IGNATIA AMARA, GELSEMIUM SEMPERVIRENSPro Weight Loss Inc.f5fb248f-e078-4dba-9bee-be0e803b6a132023-01-10WarningsExact identifier
ndc (product): 70558-0010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70558-0010-17055800100130 mL in 1 BOTTLE, DROPPER (70558-0010-1) 30 ml2021-07-290000-00-00NoNoCurrent