Home NDC 55714-2428 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 MICRURUS CORALLINUS VENOM; ALUMINUM OXIDE; ACTIVATED CHARCOAL; CAUSTICUM; CONIUM MACULATUM FLOWERING TOP; GRAPHITE; POTASSIUM DICHROMATE; POTASSIUM CHLORIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LIQUID PETROLEUM; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; VERBASCUM THAPSUS; VIOLA ODORATA
Active strength 30; 15; 15; 15; 15; 15; 15; 15; 15; 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 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 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55714-2428-2 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55714-2428-0 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 55714-2428-2 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 55714-2428-0 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 55714-2428-2 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 55714-2428-0 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 55714-2428-2 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 55714-2428-0 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 55714-2428-2 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 55714-2428-0 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 55714-2428-2 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 55714-2428-0 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55714-2428-1 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55714-2428-0 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55714-2428-2 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55714-2428-1 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55714-2428-0 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55714-2428-2 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55714-2428-1 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55714-2428-0 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55714-2428-2 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 55714-2428-0 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 55714-2428-2 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 55714-2428-0 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 55714-2428-2 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 55714-2428-0 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 55714-2428-2 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Ear Wax Build-Up
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MICRURUS CORALLINUS VENOM 30 [hp_X]/mL ALUMINUM OXIDE 15 [hp_X]/mL ACTIVATED CHARCOAL 15 [hp_X]/mL CAUSTICUM 15 [hp_X]/mL CONIUM MACULATUM FLOWERING TOP 15 [hp_X]/mL GRAPHITE 15 [hp_X]/mL POTASSIUM DICHROMATE 15 [hp_X]/mL POTASSIUM CHLORIDE 15 [hp_X]/mL LACHESIS MUTA VENOM 15 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE 15 [hp_X]/mL LIQUID PETROLEUM 15 [hp_X]/mL PULSATILLA VULGARIS 15 [hp_X]/mL SCHOENOCAULON OFFICINALE SEED 15 [hp_X]/mL SEPIA OFFICINALIS JUICE 15 [hp_X]/mL SILICON DIOXIDE 15 [hp_X]/mL SPONGIA OFFICINALIS SKELETON, ROASTED 15 [hp_X]/mL VERBASCUM THAPSUS 15 [hp_X]/mL VIOLA ODORATA 15 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 18 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55714-2428-0 Ear Wax Build-Up 15 mL in 1 BOTTLE, GLASS LIQUID 15 3 55714-2428-1 Ear Wax Build-Up 30 mL in 1 BOTTLE, GLASS LIQUID 30 3 55714-2428-2 Ear Wax Build-Up 50 mL in 1 BOTTLE, GLASS LIQUID 50 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55714-2428 EAR 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.] 3 Current NDC, Legacy NDC, 3 package rows 20250209_9302b838-6003-ba6a-e053-2995a90aedd3.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ear 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 Newton Laboratories, Inc. 9302b838-6003-ba6a-e053-2995a90aedd3 2025-02-06 Warnings Exact identifier ndc (product): 55714-2428
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55714-2428-0 55714242800 15 mL in 1 BOTTLE, GLASS 15 ml Historical 55714-2428-1 55714242801 30 mL in 1 BOTTLE, GLASS (55714-2428-1) 30 ml 2019-01-31 0000-00-00 No No Current 55714-2428-2 55714242802 50 mL in 1 BOTTLE, GLASS 50 ml Historical