FDA.reportPublic FDA data

ACNE

Product NDC
61480-145
11-digit product format
614800145
Labeler code
61480
Product ID
61480-145_440c7914-10ad-4966-e063-6394a90a013b
Type
HUMAN OTC DRUG
Nonproprietary name
Niccolum Sulphuricum, Kali Bromatum, Zincum Oxydatum, Hepar Sulphuris Calcareum, Sulphur.
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
PLYMOUTH HEALTHCARE PRODUCTS LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2016-05-01
Substance
NICKEL SULFATE HEXAHYDRATE; POTASSIUM BROMIDE; ZINC OXIDE; CALCIUM SULFIDE; SULFUR
Active strength
3; 1; 1; 3; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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
ACNE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICKEL SULFATE HEXAHYDRATE3 [hp_X]/1
POTASSIUM BROMIDE1 [hp_X]/1
ZINC OXIDE1 [hp_X]/1
CALCIUM SULFIDE3 [hp_X]/1
SULFUR1 [hp_X]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JC9WZ4FK68Internal UNII lookup
OSD78555ZMInternal UNII lookup
SOI2LOH54ZInternal UNII lookup
1MBW07J51QInternal UNII lookup
70FD1KFU70Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6cdd54fa-6997-48da-8209-86e530f83c61Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61480-145-63ACNE3 in 1 BOXTABLET, CHEWABLE37
61480-145-63ACNE20 in 1 BLISTER PACKTABLET, CHEWABLE207

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61480-145ACNE (NICCOLUM SULPHURICUM, KALI BROMATUM, ZINCUM OXYDATUM, HEPAR SULPHURIS CALCAREUM, SULPHUR.) TABLET, CHEWABLE [PLYMOUTH HEALTHCARE PRODUCTS LLC]6Current NDC, Legacy NDC, 2 package rows20241213_6cdd54fa-6997-48da-8209-86e530f83c61.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
ACNENICCOLUM SULPHURICUM, KALI BROMATUM, ZINCUM OXYDATUM, HEPAR SULPHURIS CALCAREUM, SULPHUR.PLYMOUTH HEALTHCARE PRODUCTS LLC6cdd54fa-6997-48da-8209-86e530f83c612025-11-20WarningsExact identifier
ndc (product): 61480-145

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61480-145-63614800145633 BLISTER PACK in 1 BOX (61480-145-63) / 20 TABLET, CHEWABLE in 1 BLISTER PACK3 blister pack2016-05-010000-00-00NoNoCurrent