Ear Wax Build-Up

Product NDC
55714-2428
11-digit product format
557142428
Labeler code
55714
Product ID
55714-2428_2d819832-46da-b357-e063-6394a90abd0f
Type
HUMAN OTC DRUG
Nonproprietary name
Elaps corallinus, Alumina, Carbo veg., Causticum, Conium, Graphites, Kali bic.,Kali mur., Lachesis, Lycopodium, Petroleum, Pulsatilla, Sabadilla, Sepia, Silicea, Spongia, Verbascum, Viola odorata
Dosage form
LIQUID
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-01-31
Substance
ACTIVATED CHARCOAL; ALUMINUM OXIDE; CAUSTICUM; CONIUM MACULATUM FLOWERING TOP; GRAPHITE; LACHESIS MUTA VENOM; LIQUID PETROLEUM; LYCOPODIUM CLAVATUM SPORE; MICRURUS CORALLINUS VENOM; POTASSIUM CHLORIDE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; VERBASCUM THAPSUS; VIOLA ODORATA
Active strength
15; 15; 15; 15; 15; 15; 15; 15; 30; 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
Pharmacologic classes
Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ear Wax Build-Up
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACTIVATED CHARCOAL15 [hp_X]/mL
ALUMINUM OXIDE15 [hp_X]/mL
CAUSTICUM15 [hp_X]/mL
CONIUM MACULATUM FLOWERING TOP15 [hp_X]/mL
GRAPHITE15 [hp_X]/mL
LACHESIS MUTA VENOM15 [hp_X]/mL
LIQUID PETROLEUM15 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE15 [hp_X]/mL
MICRURUS CORALLINUS VENOM30 [hp_X]/mL
POTASSIUM CHLORIDE15 [hp_X]/mL
POTASSIUM DICHROMATE15 [hp_X]/mL
PULSATILLA VULGARIS15 [hp_X]/mL
SCHOENOCAULON OFFICINALE SEED15 [hp_X]/mL
SEPIA OFFICINALIS JUICE15 [hp_X]/mL
SILICON DIOXIDE15 [hp_X]/mL
SPONGIA OFFICINALIS SKELETON, ROASTED15 [hp_X]/mL
VERBASCUM THAPSUS15 [hp_X]/mL
VIOLA ODORATA15 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2P3VWU3H10, LMI26O6933, DD5FO1WKFU, Q28R5GF371, 4QQN74LH4O, VSW71SS07I, 6ZAE7X688J, C88X29Y479, V0S6H36980, 660YQ98I10, T4423S18FM, I76KB35JEV, 6NAF1689IO, QDL83WN8C2, ETJ7Z6XBU4, 1PIP394IID, C9TD27U172, AET12U8B74

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
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
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2428-0Ear Wax Build-Up15 mL in 1 BOTTLE, GLASSLIQUID153
55714-2428-1Ear Wax Build-Up30 mL in 1 BOTTLE, GLASSLIQUID303
55714-2428-2Ear Wax Build-Up50 mL in 1 BOTTLE, GLASSLIQUID503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2428EAR WAX BUILD-UP (ELAPS CORALLINUS, ALUMINA, CARBO VEG., CAUSTICUM, CONIUM, GRAPHITES, KALI BIC.,KALI MUR., LACHESIS, LYCOPODIUM, PETROLEUM, PULSATILLA, SABADILLA, SEPIA, SILICEA, SPONGIA, VERBASCUM, VIOLA ODORATA) LIQUID [NEWTON LABORATORIES, INC.]3Current NDC, Legacy NDC, 3 package rows20250209_9302b838-6003-ba6a-e053-2995a90aedd3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-2428-05571424280015 mL in 1 BOTTLE, GLASS15 mlHistorical
55714-2428-15571424280130 mL in 1 BOTTLE, GLASS (55714-2428-1) 30 ml2019-01-310000-00-00NoNoCurrent
55714-2428-25571424280250 mL in 1 BOTTLE, GLASS50 mlHistorical