Ear Care

Product NDC
55714-4846
Requested package NDC
55714-4846-1
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55714-484655714-4846-1UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55714-484655714-4846-1UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Additional Listing Data#

Finished product
Yes
Brand name base
Ear Care
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INFLUENZA A VIRUS15 [hp_X]/mL
TELLURIUM15 [hp_X]/mL
APIS MELLIFERA15 [hp_X]/mL
ARSENIC TRIOXIDE15 [hp_X]/mL
ATROPA BELLADONNA15 [hp_X]/mL
BRYONIA ALBA ROOT15 [hp_X]/mL
CAPSICUM15 [hp_X]/mL
CAUSTICUM15 [hp_X]/mL
CINCHONA OFFICINALIS BARK15 [hp_X]/mL
CONIUM MACULATUM FLOWERING TOP15 [hp_X]/mL
SOLANUM DULCAMARA TOP15 [hp_X]/mL
FERROSOFERRIC PHOSPHATE6 [hp_X]/mL
CALCIUM SULFIDE15 [hp_X]/mL
POTASSIUM SULFATE6 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE30 [hp_X]/mL
MERCURY30 [hp_X]/mL
DAPHNE MEZEREUM BARK15 [hp_X]/mL
PHOSPHORUS15 [hp_X]/mL
PLANTAGO MAJOR15 [hp_X]/mL
ANEMONE PULSATILLA15 [hp_X]/mL
SILICON DIOXIDE15 [hp_X]/mL
VERBASCUM THAPSUS15 [hp_X]/mL
ECHINACEA, UNSPECIFIED15 [hp_X]/mL
GOLDENSEAL16 [hp_X]/mL
INFLUENZA B VIRUS15 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 25 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R9HH0NDE2EInternal UNII lookup
NQA0O090ZJInternal UNII lookup
7S82P3R43ZInternal UNII lookup
S7V92P67HOInternal UNII lookup
WQZ3G9PF0HInternal UNII lookup
T7J046YI2BInternal UNII lookup
00UK7646FGInternal UNII lookup
DD5FO1WKFUInternal UNII lookup
S003A158SBInternal UNII lookup
Q28R5GF371Internal UNII lookup
KPS1B1162NInternal UNII lookup
91GQH8I5F7Internal UNII lookup
1MBW07J51QInternal UNII lookup
1K573LC5TVInternal UNII lookup
C88X29Y479Internal UNII lookup
FXS1BY2PGLInternal UNII lookup
X2N6E405GVInternal UNII lookup
27YLU75U4WInternal UNII lookup
W2469WNO6UInternal UNII lookup
I76KB35JEVInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
da821d05-b2f0-3582-e053-2a95a90afe59Available on FDA.report

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

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
Ear CareINFLUENZINUM, 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, HYDRASTISNewton Laboratories, Inc.da821d05-b2f0-3582-e053-2a95a90afe592022-03-18WarningsExact identifier
ndc (package): 55714-4846-1
ndc (product): 55714-4846
ndc11 (package): 55714484601

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