Cold Hands - Feet

Product NDC
55714-2404
11-digit product format
557142404
Labeler code
55714
Product ID
55714-2404_b4e0ae97-f187-58c9-e053-2a95a90a0da2
Type
HUMAN OTC DRUG
Nonproprietary name
Histaminum hydrochloricum,Thyroidinum, Aconitum nap., Arsenicum alb., Bryonia, Cactus, Calc. fluor., Ceanothus, Cinchona, Convallaria, Digitalis, Gelsemium, Glonoinum, Hydrocoyle, Kali carb., Lachesis, Naja, nat carb., Nat mur., Nux vom., Phosphorus, Pullsatilla, Rhus toxicodendron, Strophanthus hispidus, Sulphur, Echinacea
Dosage form
LIQUID
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2018-11-08
Substance
ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CEANOTHUS AMERICANUS LEAF; CENTELLA ASIATICA; CINCHONA OFFICINALIS BARK; CONVALLARIA MAJALIS; DIGITALIS; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; HISTAMINE DIHYDROCHLORIDE; LACHESIS MUTA VENOM; NAJA NAJA VENOM; NITROGLYCERIN; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SELENICEREUS GRANDIFLORUS STEM; SODIUM CARBONATE; SODIUM CHLORIDE; STROPHANTHUS HISPIDUS SEED; STRYCHNOS NUX-VOMICA SEED; SULFUR; THYROID, UNSPECIFIED; TOXICODENDRON PUBESCENS LEAF
Active strength
15; 15; 15; 15; 15; 15; 15; 15; 15; 6; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [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; [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], Increased Histamine Release [PE], Increased IgG Production [PE], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cold Hands - Feet
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACONITUM NAPELLUS15 [hp_X]/mL
ARSENIC TRIOXIDE15 [hp_X]/mL
BRYONIA ALBA ROOT15 [hp_X]/mL
CALCIUM FLUORIDE15 [hp_X]/mL
CEANOTHUS AMERICANUS LEAF15 [hp_X]/mL
CENTELLA ASIATICA15 [hp_X]/mL
CINCHONA OFFICINALIS BARK15 [hp_X]/mL
CONVALLARIA MAJALIS15 [hp_X]/mL
DIGITALIS15 [hp_X]/mL
ECHINACEA, UNSPECIFIED6 [hp_X]/mL
GELSEMIUM SEMPERVIRENS ROOT15 [hp_X]/mL
HISTAMINE DIHYDROCHLORIDE15 [hp_X]/mL
LACHESIS MUTA VENOM15 [hp_X]/mL
NAJA NAJA VENOM15 [hp_X]/mL
NITROGLYCERIN15 [hp_X]/mL
PHOSPHORUS15 [hp_X]/mL
POTASSIUM CARBONATE15 [hp_X]/mL
PULSATILLA VULGARIS15 [hp_X]/mL
SELENICEREUS GRANDIFLORUS STEM15 [hp_X]/mL
SODIUM CARBONATE15 [hp_X]/mL
SODIUM CHLORIDE15 [hp_X]/mL
STROPHANTHUS HISPIDUS SEED15 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED15 [hp_X]/mL
SULFUR15 [hp_X]/mL
THYROID, UNSPECIFIED15 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF15 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU0NQ8555JD, S7V92P67HO, T7J046YI2B, O3B55K4YKI, 25B1Y14T8N, 7M867G6T1U, S003A158SB, QHH4HVF5QE, F1T8QT9U8B, 4N9P6CC1DX, 639KR60Q1Q, 3POA0Q644U, VSW71SS07I, ZZ4AG7L7VM, G59M7S0WS3, 27YLU75U4W, BQN1B9B9HA, I76KB35JEV, 7114SV0MYK, 45P3261C7T

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2404-0Cold Hands - Feet15 mL in 1 BOTTLE, GLASSLIQUID153
55714-2404-1Cold Hands - Feet30 mL in 1 BOTTLE, GLASSLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2404COLD HANDS - FEET (HISTAMINUM HYDROCHLORICUM,THYROIDINUM, ACONITUM NAP., ARSENICUM ALB., BRYONIA, CACTUS, CALC. FLUOR., CEANOTHUS, CINCHONA, CONVALLARIA, DIGITALIS, GELSEMIUM, GLONOINUM, HYDROCOYLE, KALI CARB., LACHESIS, NAJA, NAT CARB., NAT MUR., NUX VOM., PHOSPHORUS, PULLSATILLA, RHUS TOXICODENDRON, STROPHANTHUS HISPIDUS, SULPHUR, ECHINACEA) LIQUID [NEWTON LABORATORIES, INC.]3Current NDC, Legacy NDC, 2 package rows20201125_7a2b4f28-2128-a8b2-e053-2a91aa0a2402.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-2404-05571424040015 mL in 1 BOTTLE, GLASS15 mlHistorical
55714-2404-15571424040130 mL in 1 BOTTLE, GLASS (55714-2404-1) 30 ml2018-11-080000-00-00NoNoCurrent