FDA.reportPublic FDA data

Acunol

Product NDC
61480-137
11-digit product format
614800137
Labeler code
61480
Product ID
61480-137_2b244a53-0f31-3410-e063-6394a90a06d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nickel Sulfate, Potassium Bromide, Sodium Bromide, Zinc Sulfate Anhydrous, and Sulfur
Dosage form
TABLET
Route
ORAL
Labeler
PLYMOUTH HEALTHCARE PRODUCTS LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2006-04-18
Substance
NICKEL SULFATE; POTASSIUM BROMIDE; SODIUM BROMIDE; SULFUR; ZINC SULFATE ANHYDROUS
Active strength
1; 1; 1; 1; 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICKEL SULFATE1 [hp_X]/1
POTASSIUM BROMIDE1 [hp_X]/1
SODIUM BROMIDE1 [hp_X]/1
SULFUR1 [hp_X]/1
ZINC SULFATE ANHYDROUS1 [hp_X]/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4FLT4T3WUN, OSD78555ZM, LC1V549NOM, 70FD1KFU70, 0J6Z13X3WO

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61480-137-05Acunol90 in 1 BOTTLETABLET9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61480-137-05EA - Each61480-13733c10d5d-ef6a-4a08-bdb3-a632b514b2be12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Nickel SulfateACTIVE INGREDIENT4FLT4T3WUNACUNOL (NICKEL SULFATE, POTASSIUM BROMIDE, SODIUM BROMIDE, ZINC SULFATE ANHYDROUS, AND SULFUR) TABLET [PLYMOUTH HEALTHCARE PRODUCTS LLC]7
Potassium BromideACTIVE INGREDIENTOSD78555ZMACUNOL (NICKEL SULFATE, POTASSIUM BROMIDE, SODIUM BROMIDE, ZINC SULFATE ANHYDROUS, AND SULFUR) TABLET [PLYMOUTH HEALTHCARE PRODUCTS LLC]7
Sodium BromideACTIVE INGREDIENTLC1V549NOMACUNOL (NICKEL SULFATE, POTASSIUM BROMIDE, SODIUM BROMIDE, ZINC SULFATE ANHYDROUS, AND SULFUR) TABLET [PLYMOUTH HEALTHCARE PRODUCTS LLC]7
SulfurACTIVE INGREDIENT70FD1KFU70ACUNOL (NICKEL SULFATE, POTASSIUM BROMIDE, SODIUM BROMIDE, ZINC SULFATE ANHYDROUS, AND SULFUR) TABLET [PLYMOUTH HEALTHCARE PRODUCTS LLC]7
Zinc Sulfate AnhydrousACTIVE INGREDIENT0J6Z13X3WOACUNOL (NICKEL SULFATE, POTASSIUM BROMIDE, SODIUM BROMIDE, ZINC SULFATE ANHYDROUS, AND SULFUR) TABLET [PLYMOUTH HEALTHCARE PRODUCTS LLC]7
BROMIDE IONACTIVE MOIETY952902IX06ACUNOL (NICKEL SULFATE, POTASSIUM BROMIDE, SODIUM BROMIDE, ZINC SULFATE ANHYDROUS, AND SULFUR) TABLET [PLYMOUTH HEALTHCARE PRODUCTS LLC]7
NICKEL CATIONACTIVE MOIETYOIS2CXW7AMACUNOL (NICKEL SULFATE, POTASSIUM BROMIDE, SODIUM BROMIDE, ZINC SULFATE ANHYDROUS, AND SULFUR) TABLET [PLYMOUTH HEALTHCARE PRODUCTS LLC]7
SulfurACTIVE MOIETY70FD1KFU70ACUNOL (NICKEL SULFATE, POTASSIUM BROMIDE, SODIUM BROMIDE, ZINC SULFATE ANHYDROUS, AND SULFUR) TABLET [PLYMOUTH HEALTHCARE PRODUCTS LLC]7
ZINC CATIONACTIVE MOIETY13S1S8SF37ACUNOL (NICKEL SULFATE, POTASSIUM BROMIDE, SODIUM BROMIDE, ZINC SULFATE ANHYDROUS, AND SULFUR) TABLET [PLYMOUTH HEALTHCARE PRODUCTS LLC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61480-137ACUNOL (NICKEL SULFATE, POTASSIUM BROMIDE, SODIUM BROMIDE, ZINC SULFATE ANHYDROUS, AND SULFUR) TABLET [PLYMOUTH HEALTHCARE PRODUCTS LLC]13Current NDC, Legacy NDC, 1 package rows20250109_f7f1c99e-1a67-4b34-b1f4-0ac38b9d8006.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61480-137-056148001370590 TABLET in 1 BOTTLE (61480-137-05) 90 tablet2006-04-180000-00-00NoNoCurrent