FDA.reportPublic FDA data

Ear Ringing

Product NDC
55714-2589
11-digit product format
557142589
Labeler code
55714
Product ID
55714-2589_1045ca15-6ed3-a700-e063-6394a90ad96e
Type
HUMAN OTC DRUG
Nonproprietary name
Aconitum nap., Baryta carb., Baryta mur., Capsicum, Causticum, Chenopodium anthelminticum, Chininum sulphuricum, Cinchona, Glonoinum, Graphites, Hydrastis, Kali bic., Kali mur., Lycopodium, Phosphorus, Pulsatilla, Salicylicum ac., Tabacum, Thiosinaminum, Viola odorata
Dosage form
PELLET
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2024-01-31
Substance
ACONITUM NAPELLUS; ALLYLTHIOUREA; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CAPSICUM; CAUSTICUM; CINCHONA OFFICINALIS BARK; DYSPHANIA AMBROSIOIDES; GOLDENSEAL; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; NITROGLYCERIN; PHOSPHORUS; POTASSIUM CHLORIDE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; QUININE SULFATE; SALICYLIC ACID; TOBACCO LEAF; VIOLA ODORATA
Active strength
15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
Pharmacologic classes
Allergens [CS], Allergens [CS], Antimalarial [EPC], 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], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Plant Proteins [CS], Potassium Compounds [CS], Potassium Salt [EPC], Vasodilation [PE], 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 Ringing
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LYCOPODIUM CLAVATUM SPORE15 [hp_X]/g
PHOSPHORUS15 [hp_X]/g
PULSATILLA VULGARIS15 [hp_X]/g
SALICYLIC ACID15 [hp_X]/g
TOBACCO LEAF15 [hp_X]/g
ALLYLTHIOUREA15 [hp_X]/g
VIOLA ODORATA15 [hp_X]/g
ACONITUM NAPELLUS15 [hp_X]/g
BARIUM CARBONATE15 [hp_X]/g
BARIUM CHLORIDE DIHYDRATE15 [hp_X]/g
CAPSICUM15 [hp_X]/g
CAUSTICUM15 [hp_X]/g
DYSPHANIA AMBROSIOIDES15 [hp_X]/g
QUININE SULFATE15 [hp_X]/g
CINCHONA OFFICINALIS BARK15 [hp_X]/g
NITROGLYCERIN15 [hp_X]/g
GRAPHITE15 [hp_X]/g
GOLDENSEAL15 [hp_X]/g
POTASSIUM DICHROMATE15 [hp_X]/g
POTASSIUM CHLORIDE15 [hp_X]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 20 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C88X29Y479Internal UNII lookup
27YLU75U4WInternal UNII lookup
I76KB35JEVInternal UNII lookup
O414PZ4LPZInternal UNII lookup
6YR2608RSUInternal UNII lookup
706IDJ14B7Internal UNII lookup
AET12U8B74Internal UNII lookup
U0NQ8555JDInternal UNII lookup
6P669D8HQ8Internal UNII lookup
EL5GJ3U77EInternal UNII lookup
00UK7646FGInternal UNII lookup
DD5FO1WKFUInternal UNII lookup
4H5RSU087IInternal UNII lookup
KF7Z0E0Q2BInternal UNII lookup
S003A158SBInternal UNII lookup
G59M7S0WS3Internal UNII lookup
4QQN74LH4OInternal UNII lookup
ZW3Z11D0JVInternal UNII lookup
T4423S18FMInternal UNII lookup
660YQ98I10Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1045ab27-c4d5-fcbd-e063-6294a90a5176Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0Product name220250117
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
00358076-c817-430b-b924-11d717dc307cProduct name120160718
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
22bca8fc-c2b1-897d-b515-117a7522ccaeProduct name320150731
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2589-1Ear Ringing28 g in 1 BOTTLE, GLASSPELLET281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2589EAR RINGING (ACONITUM NAP., BARYTA CARB., BARYTA MUR., CAPSICUM, CAUSTICUM, CHENOPODIUM ANTHELMINTICUM, CHININUM SULPHURICUM, CINCHONA, GLONOINUM, GRAPHITES, HYDRASTIS, KALI BIC., KALI MUR., LYCOPODIUM, PHOSPHORUS, PULSATILLA, SALICYLICUM AC., TABACUM, THIOSINAMINUM, VIOLA ODORATA) PELLET [NEWTON LABORATORIES, INC.]1Current NDC, 1 package rows20240202_1045ab27-c4d5-fcbd-e063-6294a90a5176.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 RingingACONITUM NAP., BARYTA CARB., BARYTA MUR., CAPSICUM, CAUSTICUM, CHENOPODIUM ANTHELMINTICUM, CHININUM SULPHURICUM, CINCHONA, GLONOINUM, GRAPHITES, HYDRASTIS, KALI BIC., KALI MUR., LYCOPODIUM, PHOSPHORUS, PULSATILLA, SALICYLICUM AC., TABACUM, THIOSINAMINUM, VIOLA ODORATANewton Laboratories, Inc.1045ab27-c4d5-fcbd-e063-6294a90a51762024-01-31WarningsExact identifier
ndc (product): 55714-2589

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55714-2589-15571425890128 g in 1 BOTTLE, GLASS (55714-2589-1) 28 g2024-01-31NoNoCurrent