FDA.reportPublic FDA data

PSORIASIS

Product NDC
61480-105
11-digit product format
614800105
Labeler code
61480
Product ID
61480-105_440c889d-1e86-767e-e063-6394a90abaa8
Type
HUMAN OTC DRUG
Nonproprietary name
Niccolum Sulphuricum, Natrum Bromatum, Zincum Bromatum, Kali Bromatum, Kali Sulphuricum.
Dosage form
LIQUID
Route
ORAL
Labeler
PLYMOUTH HEALTHCARE PRODUCTS LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2016-12-12
Substance
NICKEL SULFATE HEXAHYDRATE; SODIUM BROMIDE; ZINC BROMIDE; POTASSIUM BROMIDE; POTASSIUM SULFATE
Active strength
3; 2; 4; 1; 4 [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
PSORIASIS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICKEL SULFATE HEXAHYDRATE3 [hp_X]/237mL
SODIUM BROMIDE2 [hp_X]/237mL
ZINC BROMIDE4 [hp_X]/237mL
POTASSIUM BROMIDE1 [hp_X]/237mL
POTASSIUM SULFATE4 [hp_X]/237mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JC9WZ4FK68Internal UNII lookup
LC1V549NOMInternal UNII lookup
OO7ZBU9703Internal UNII lookup
OSD78555ZMInternal UNII lookup
1K573LC5TVInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7ad9e8ac-c8a3-4cab-8ab2-15feaf4bd3dcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
95250459-30e4-45c1-b08a-993044f49109Product name220250805
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61480-105-03PSORIASIS237 mL in 1 BOTTLELIQUID2376

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61480-105PSORIASIS (NICCOLUM SULPHURICUM, NATRUM BROMATUM, ZINCUM BROMATUM, KALI BROMATUM, KALI SULPHURICUM.) LIQUID [PLYMOUTH HEALTHCARE PRODUCTS LLC]5Current NDC, Legacy NDC, 1 package rows20241213_7ad9e8ac-c8a3-4cab-8ab2-15feaf4bd3dc.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
PSORIASISNICCOLUM SULPHURICUM, NATRUM BROMATUM, ZINCUM BROMATUM, KALI BROMATUM, KALI SULPHURICUM.PLYMOUTH HEALTHCARE PRODUCTS LLC7ad9e8ac-c8a3-4cab-8ab2-15feaf4bd3dc2025-11-20WarningsExact identifier
ndc (product): 61480-105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61480-105-0361480010503237 mL in 1 BOTTLE (61480-105-03) 237 ml2016-12-120000-00-00NoNoCurrent