Ear Care

Product NDC
55714-1537
11-digit product format
557141537
Labeler code
55714
Product ID
55714-1537_da717cf0-54b0-c4e2-e053-2995a90ac97c
Type
HUMAN OTC DRUG
Nonproprietary name
Echinacea, Hydrastis canadensis, Apis mellifica, Arsenicum album, Belladonna, Bryonia, Capsicum annuum, Causticum, Cinchona officinalis, Conium maculatum, Dulcamara, Ferrum phosphoricum, Hepar sulphuris calcareum, Kali sulphuricum, Lycopodium clavatum, Mercurius vivus, Mezereum, Phosphorus, Plantago major, Pulsatilla, Silicea, Verbascum thapsus, Tellurium metallicum, Influenzinum
Dosage form
LIQUID
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-03-07
Substance
ANEMONE PULSATILLA; APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CAPSICUM; CAUSTICUM; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; FERROSOFERRIC PHOSPHATE; GOLDENSEAL; INFLUENZA A VIRUS; INFLUENZA B VIRUS; LYCOPODIUM CLAVATUM SPORE; MERCURY; PHOSPHORUS; PLANTAGO MAJOR; POTASSIUM SULFATE; SILICON DIOXIDE; SOLANUM DULCAMARA TOP; TELLURIUM; VERBASCUM THAPSUS
Active strength
15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 6; 15; 6; 30; 30; 15; 15; 15; 15; 15; 15; 15; 16; 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
Pharmacologic classes
Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Potassium Compounds [CS], Potassium Salt [EPC], Standardized Insect Venom Allergenic Extract [EPC], Vegetable 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
Ear Care
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANEMONE PULSATILLA15 [hp_X]/mL
APIS MELLIFERA15 [hp_X]/mL
ARSENIC TRIOXIDE15 [hp_X]/mL
ATROPA BELLADONNA15 [hp_X]/mL
BRYONIA ALBA ROOT15 [hp_X]/mL
CALCIUM SULFIDE15 [hp_X]/mL
CAPSICUM15 [hp_X]/mL
CAUSTICUM15 [hp_X]/mL
CINCHONA OFFICINALIS BARK15 [hp_X]/mL
CONIUM MACULATUM FLOWERING TOP15 [hp_X]/mL
DAPHNE MEZEREUM BARK15 [hp_X]/mL
ECHINACEA, UNSPECIFIED6 [hp_X]/mL
FERROSOFERRIC PHOSPHATE15 [hp_X]/mL
GOLDENSEAL6 [hp_X]/mL
INFLUENZA A VIRUS30 [hp_X]/mL
INFLUENZA B VIRUS30 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE15 [hp_X]/mL
MERCURY15 [hp_X]/mL
PHOSPHORUS15 [hp_X]/mL
PLANTAGO MAJOR15 [hp_X]/mL
POTASSIUM SULFATE15 [hp_X]/mL
SILICON DIOXIDE15 [hp_X]/mL
SOLANUM DULCAMARA TOP15 [hp_X]/mL
TELLURIUM16 [hp_X]/mL
VERBASCUM THAPSUS15 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI76KB35JEV, 7S82P3R43Z, S7V92P67HO, WQZ3G9PF0H, T7J046YI2B, 1MBW07J51Q, 00UK7646FG, DD5FO1WKFU, S003A158SB, Q28R5GF371, X2N6E405GV, 4N9P6CC1DX, 91GQH8I5F7, ZW3Z11D0JV, R9HH0NDE2E, 1314JZ2X6W, C88X29Y479, FXS1BY2PGL, 27YLU75U4W, W2469WNO6U

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
55714-1537-1Ear Care30 mL in 1 BOTTLE, GLASSLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-1537EAR CARE (ECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUM) LIQUID [NEWTON LABORATORIES, INC.]1Current NDC, Legacy NDC, 1 package rows20220319_da717cf0-54af-c4e2-e053-2995a90ac97c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-1537-15571415370130 mL in 1 BOTTLE, GLASS (55714-1537-1) 30 ml2022-03-070000-00-00NoNoCurrent