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

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55714-4790-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55714-4790-10efc9e666f02…f202fb6c5f17…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAUSTICUM15 [hp_X]/mL
CHELIDONIUM MAJUS15 [hp_X]/mL
SOLANUM DULCAMARA WHOLE6 [hp_X]/mL
CALCIUM SULFIDE15 [hp_X]/mL
CENTELLA ASIATICA15 [hp_X]/mL
ECHINACEA, UNSPECIFIED15 [hp_X]/mL
JUGLANS REGIA WHOLE15 [hp_X]/mL
GOLD15 [hp_X]/mL
TARAXACUM OFFICINALE15 [hp_X]/mL
ANTIMONY TRISULFIDE15 [hp_X]/mL
BERBERIS AQUIFOLIUM WHOLE6 [hp_X]/mL
CALVATIA GIGANTEA WHOLE15 [hp_X]/mL
POTASSIUM BROMIDE15 [hp_X]/mL
ARCTIUM LAPPA WHOLE6 [hp_X]/mL
ARSENIC TRIOXIDE15 [hp_X]/mL
ACTIVATED CHARCOAL15 [hp_X]/mL
GRAPHITE15 [hp_X]/mL
ZINC15 [hp_X]/mL
POTASSIUM IODIDE15 [hp_X]/mL
LEDUM PALUSTRE WHOLE15 [hp_X]/mL
SILICON DIOXIDE15 [hp_X]/mL
SULFUR IODIDE15 [hp_X]/mL
LYCOPODIUM CLAVATUM WHOLE6 [hp_X]/mL
STRYCHNOS NUX-VOMICA WHOLE15 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 24 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
DD5FO1WKFUInternal UNII lookup
7E889U5RNNInternal UNII lookup
G72JA9DHK5Internal UNII lookup
1MBW07J51QInternal UNII lookup
7M867G6T1UInternal UNII lookup
4N9P6CC1DXInternal UNII lookup
87EJ76IO83Internal UNII lookup
79Y1949PYOInternal UNII lookup
39981FM375Internal UNII lookup
F79059A38UInternal UNII lookup
J4WG1JVR05Internal UNII lookup
BR6B7CG29TInternal UNII lookup
OSD78555ZMInternal UNII lookup
73070DU1LAInternal UNII lookup
S7V92P67HOInternal UNII lookup
2P3VWU3H10Internal UNII lookup
4QQN74LH4OInternal UNII lookup
J41CSQ7QDSInternal UNII lookup
1C4QK22F9JInternal UNII lookup
1N8KG72C5MInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
92afe017-74c7-16c6-e053-2995a90a5c7dAvailable on FDA.report

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

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
Acne - Cystic AcneECHINACEA, 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, SILICEANewton Laboratories, Inc92afe017-74c7-16c6-e053-2995a90a5c7d2020-12-02WarningsExact identifier
ndc (product): 55714-4790

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