Acne - Cystic Acne

Product NDC
55714-4790
11-digit product format
557144790
Labeler code
55714
Product ID
55714-4790_b57eb850-8be7-891c-e053-2995a90a5c46
Type
HUMAN OTC DRUG
Nonproprietary name
Echinacea, juglans regia, lappa major, taraxacum officinale, antimonium crudum, arsenicum album, aurum metallicum, berberis aquifolium, Bovista, carbo vegetabilis, causticum, chelidonium majus, dulcamara, graphites, hepar sulphuris calcareum, hydrocotyle asiatica, kali bromatum, kali iodatum, ledum palustre, lycopdium clavatum, nux vomica, Sulphur iodatum, zincum metallicum, silicea
Dosage form
LIQUID
Route
ORAL
Labeler
Newton Laboratories, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-09-02
Substance
ACTIVATED CHARCOAL; ANTIMONY TRISULFIDE; ARCTIUM LAPPA WHOLE; ARSENIC TRIOXIDE; BERBERIS AQUIFOLIUM WHOLE; CALCIUM SULFIDE; CALVATIA GIGANTEA WHOLE; CAUSTICUM; CENTELLA ASIATICA; CHELIDONIUM MAJUS; ECHINACEA, UNSPECIFIED; GOLD; GRAPHITE; JUGLANS REGIA WHOLE; LEDUM PALUSTRE WHOLE; LYCOPODIUM CLAVATUM WHOLE; POTASSIUM BROMIDE; POTASSIUM IODIDE; SILICON DIOXIDE; SOLANUM DULCAMARA WHOLE; STRYCHNOS NUX-VOMICA WHOLE; SULFUR IODIDE; TARAXACUM OFFICINALE; ZINC
Active strength
15; 15; 6; 15; 15; 15; 15; 15; 15; 15; 6; 15; 15; 6; 15; 15; 15; 15; 15; 15; 15; 15; 6; 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
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acne - Cystic Acne
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACTIVATED CHARCOAL15 [hp_X]/mL
ANTIMONY TRISULFIDE15 [hp_X]/mL
ARCTIUM LAPPA WHOLE6 [hp_X]/mL
ARSENIC TRIOXIDE15 [hp_X]/mL
BERBERIS AQUIFOLIUM WHOLE15 [hp_X]/mL
CALCIUM SULFIDE15 [hp_X]/mL
CALVATIA GIGANTEA WHOLE15 [hp_X]/mL
CAUSTICUM15 [hp_X]/mL
CENTELLA ASIATICA15 [hp_X]/mL
CHELIDONIUM MAJUS15 [hp_X]/mL
ECHINACEA, UNSPECIFIED6 [hp_X]/mL
GOLD15 [hp_X]/mL
GRAPHITE15 [hp_X]/mL
JUGLANS REGIA WHOLE6 [hp_X]/mL
LEDUM PALUSTRE WHOLE15 [hp_X]/mL
LYCOPODIUM CLAVATUM WHOLE15 [hp_X]/mL
POTASSIUM BROMIDE15 [hp_X]/mL
POTASSIUM IODIDE15 [hp_X]/mL
SILICON DIOXIDE15 [hp_X]/mL
SOLANUM DULCAMARA WHOLE15 [hp_X]/mL
STRYCHNOS NUX-VOMICA WHOLE15 [hp_X]/mL
SULFUR IODIDE15 [hp_X]/mL
TARAXACUM OFFICINALE6 [hp_X]/mL
ZINC15 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2P3VWU3H10, F79059A38U, 73070DU1LA, S7V92P67HO, J4WG1JVR05, 1MBW07J51Q, BR6B7CG29T, DD5FO1WKFU, 7M867G6T1U, 7E889U5RNN, 4N9P6CC1DX, 79Y1949PYO, 4QQN74LH4O, 87EJ76IO83, 1N8KG72C5M, 005ICF6L27, OSD78555ZM, 1C4QK22F9J, ETJ7Z6XBU4, G72JA9DHK5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4790-1Acne - Cystic Acne30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4790ACNE - CYSTIC ACNE (ECHINACEA, JUGLANS REGIA, LAPPA MAJOR, TARAXACUM OFFICINALE, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, AURUM METALLICUM, BERBERIS AQUIFOLIUM, BOVISTA, CARBO VEGETABILIS, CAUSTICUM, CHELIDONIUM MAJUS, DULCAMARA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, HYDROCOTYLE ASIATICA, KALI BROMATUM, KALI IODATUM, LEDUM PALUSTRE, LYCOPDIUM CLAVATUM, NUX VOMICA, SULPHUR IODATUM, ZINCUM METALLICUM, SILICEA) LIQUID [NEWTON LABORATORIES, INC]2Current NDC, Legacy NDC, 1 package rows20201203_92afe017-74c7-16c6-e053-2995a90a5c7d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-4790-15571447900130 mL in 1 BOTTLE, GLASS (55714-4790-1) 30 ml2019-09-020000-00-00NoNoCurrent