FDA.reportPublic FDA data

Dr. Johne SKIN TAG REMOVER

Product NDC
85818-001
11-digit product format
858180001
Labeler code
85818
Product ID
85818-001_9b9187e3-9ed3-4fc9-aa61-fdeb3dd0bee8
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Dr.Johnes LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-02
Substance
SALICYLIC ACID
Active strength
170 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dr. Johne SKIN TAG REMOVER
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID170 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO414PZ4LPZ
Rxcui312881

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85818-001-01Dr. Johne SKIN TAG REMOVER10 mL in 1 TUBESOLUTION109
85818-001-02Dr. Johne SKIN TAG REMOVER7 mL in 1 TUBESOLUTION79
85818-001-03Dr. Johne SKIN TAG REMOVER8 mL in 1 TUBESOLUTION89
85818-001-04Dr. Johne SKIN TAG REMOVER9 mL in 1 TUBESOLUTION99

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312881salicylic acid 17 % Topical SolutionPSN6c5adc3c-9d45-449a-ad42-f9571851cd189
312881salicylic acid 170 MG/ML Topical SolutionSCD6c5adc3c-9d45-449a-ad42-f9571851cd189
312881salicylic acid 17 % Topical SolutionSY6c5adc3c-9d45-449a-ad42-f9571851cd189

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85818-001-018581800010110 mL in 1 TUBE (85818-001-01) 10 ml2025-06-02NoNoHistorical
85818-001-02858180001027 mL in 1 TUBE (85818-001-02) 7 ml2025-06-02NoNoHistorical
85818-001-03858180001038 mL in 1 TUBE (85818-001-03) 8 ml2025-06-02NoNoHistorical
85818-001-04858180001049 mL in 1 TUBE (85818-001-04) 9 ml2025-06-02NoNoHistorical