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
ACONITUM NAPELLUS WHOLE; ANAMIRTA COCCULUS SEED; ANGELICA SINENSIS ROOT; ARSENIC TRIOXIDE; CLEMATIS VITALBA FLOWER; COCOA; GELSEMIUM SEMPERVIRENS ROOT; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; LITHIUM CARBONATE; MACROPIPER METHYSTICUM ROOT; ORNITHOGALUM UMBELLATUM FLOWERING TOP; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PASSIFLORA INCARNATA FLOWERING TOP; PRUNUS CERASIFERA FLOWER; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; STRYCHNOS IGNATII SEED; SUS SCROFA ADRENAL GLAND; VALERIAN
Active strength
12; 12; 6; 12; 3; 6; 12; 3; 3; 6; 7; 3; 12; 3; 6; 12; 6; 12; 8; 6 [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

Additional Listing Data#

Finished product
Yes
Brand name base
Calm Anxiety and Stress
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU0NQ8555JD, 810258W28U, B66F4574UG, S7V92P67HO, 7SCP4N87CI, D9108TZ9KG, 639KR60Q1Q, 51BRR32WPP, AJU5O1A5ZV, 2BMD2GNA4V, BOW48C81XP, CZD6M4PY4B, 2E32821G6I, CLF5YFS11O, 0KD7R09EAS, Y0F0BU8RDU, 95IT3W8JZE, 1NM3M2487K, 398IYQ16YV, JWF5YAW3QW

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

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