Ear Care

Product NDC
55714-4846
11-digit product format
557144846
Labeler code
55714
Product ID
55714-4846_da821e18-7dab-2f4e-e053-2995a90ac2d6
Type
HUMAN OTC DRUG
Nonproprietary name
Influenzinum, Tellurium metallicum, Apis mel., Arsenicum alb., Belladonna, Bryonia, Capsicum, Causticum, Cinchona, Conium, Dulcamara, Ferrum phosphoricum, Hepar sulph. calc.,Kali sulph., Lycopodium, Merc. viv., Mezereum, Phosphorus, Plantago, Pulsatilla, Silicea, Verbascum, Echinacea, Hydrastis
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], 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
95250459-30e4-45c1-b08a-993044f49109Product name220250805
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4846-1Ear Care30 mL in 1 BOTTLE, GLASSLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4846EAR CARE (INFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTIS) LIQUID [NEWTON LABORATORIES, INC.]1Current NDC, Legacy NDC, 1 package rows20220319_da821d05-b2f0-3582-e053-2a95a90afe59.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-4846-15571448460130 mL in 1 BOTTLE, GLASS (55714-4846-1) 30 ml2022-03-070000-00-00NoNoCurrent