Acne

Product NDC
55714-2385
Requested package NDC
55714-2385-1
11-digit product format
557142385
Labeler code
55714
Product ID
55714-2385_b4ddcbcc-e895-1c05-e053-2995a90a63a0
Type
HUMAN OTC DRUG
Nonproprietary name
Antimon. crud., Arsenicum alb., Aur. met., Berber. aqui., Bovista, Carbo veg., Causticum, Chelidonium majus, Dulcamara, Graphites, Hepar sulph. calc., Hydrocotyle, Kali brom., Kali iod., Ledum, Lycopodium, Nux vom., Silicea, Sulphur iod., Zinc. met., Echinacea, Juglans regia, Lappa, Taraxacum
Dosage form
PELLET
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2018-10-31
Substance
ACTIVATED CHARCOAL; ANTIMONY TRISULFIDE; ARCTIUM LAPPA ROOT; ARSENIC CATION (3+); CALCIUM SULFIDE; CAUSTICUM; CENTELLA ASIATICA; CHELIDONIUM MAJUS; ECHINACEA, UNSPECIFIED; ENGLISH WALNUT; GIANT PUFFBALL; GOLD; GRAPHITE; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; MAHONIA AQUIFOLIUM ROOT BARK; POTASSIUM BROMIDE; POTASSIUM IODIDE; SILICON DIOXIDE; SOLANUM DULCAMARA TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR IODIDE; TARAXACUM OFFICINALE; ZINC
Active strength
15; 15; 6; 15; 15; 15; 15; 15; 6; 6; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 6; 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; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
Pharmacologic classes
Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Nut Proteins [EXT], Plant Proteins [CS], Seed Storage Proteins [CS], 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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55714-238555714-2385-1UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55714-238555714-2385-1UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANTIMONY TRISULFIDE15 [hp_X]/g
ARSENIC CATION (3+)15 [hp_X]/g
GOLD6 [hp_X]/g
MAHONIA AQUIFOLIUM ROOT BARK15 [hp_X]/g
GIANT PUFFBALL15 [hp_X]/g
ACTIVATED CHARCOAL15 [hp_X]/g
CAUSTICUM15 [hp_X]/g
CHELIDONIUM MAJUS15 [hp_X]/g
SOLANUM DULCAMARA TOP6 [hp_X]/g
GRAPHITE6 [hp_X]/g
CALCIUM SULFIDE15 [hp_X]/g
CENTELLA ASIATICA15 [hp_X]/g
POTASSIUM BROMIDE15 [hp_X]/g
POTASSIUM IODIDE15 [hp_X]/g
LEDUM PALUSTRE TWIG15 [hp_X]/g
LYCOPODIUM CLAVATUM SPORE15 [hp_X]/g
STRYCHNOS NUX-VOMICA SEED15 [hp_X]/g
SILICON DIOXIDE15 [hp_X]/g
SULFUR IODIDE15 [hp_X]/g
ZINC15 [hp_X]/g
ECHINACEA, UNSPECIFIED15 [hp_X]/g
ENGLISH WALNUT15 [hp_X]/g
ARCTIUM LAPPA ROOT6 [hp_X]/g
TARAXACUM OFFICINALE15 [hp_X]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 24 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F79059A38UInternal UNII lookup
C96613F5AVInternal UNII lookup
79Y1949PYOInternal UNII lookup
VZJ9F3C3SBInternal UNII lookup
I6839Y031AInternal UNII lookup
2P3VWU3H10Internal UNII lookup
DD5FO1WKFUInternal UNII lookup
7E889U5RNNInternal UNII lookup
KPS1B1162NInternal UNII lookup
4QQN74LH4OInternal UNII lookup
1MBW07J51QInternal UNII lookup
7M867G6T1UInternal UNII lookup
OSD78555ZMInternal UNII lookup
1C4QK22F9JInternal UNII lookup
877L01IZ0PInternal UNII lookup
C88X29Y479Internal UNII lookup
269XH13919Internal UNII lookup
ETJ7Z6XBU4Internal UNII lookup
L6L8KA2AA0Internal UNII lookup
J41CSQ7QDSInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
798d5f34-819a-9895-e053-2991aa0a1d62Available 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
55714-2385-1Acne28 g in 1 BOTTLE, GLASSPELLET282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2385ACNE (ANTIMON. CRUD., ARSENICUM ALB., AUR. MET., BERBER. AQUI., BOVISTA, CARBO VEG., CAUSTICUM, CHELIDONIUM MAJUS, DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., HYDROCOTYLE, KALI BROM., KALI IOD., LEDUM, LYCOPODIUM, NUX VOM., SILICEA, SULPHUR IOD., ZINC. MET., ECHINACEA, JUGLANS REGIA, LAPPA, TARAXACUM) PELLET [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20201125_798d5f34-819a-9895-e053-2991aa0a1d62.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
AcneANTIMON. CRUD., ARSENICUM ALB., AUR. MET., BERBER. AQUI., BOVISTA, CARBO VEG., CAUSTICUM, CHELIDONIUM MAJUS, DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., HYDROCOTYLE, KALI BROM., KALI IOD., LEDUM, LYCOPODIUM, NUX VOM., SILICEA, SULPHUR IOD., ZINC. MET., ECHINACEA, JUGLANS REGIA, LAPPA, TARAXACUMNewton Laboratories, Inc.798d5f34-819a-9895-e053-2991aa0a1d622020-11-24WarningsExact identifier
ndc (package): 55714-2385-1
ndc (product): 55714-2385
ndc11 (package): 55714238501

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-2385-15571423850128 g in 1 BOTTLE, GLASS (55714-2385-1) 28 g2018-10-310000-00-00NoNoCurrent