FDA.reportPublic FDA data

Dr.Johnes SKIN TAG REMOVER

Product NDC
85818-002
11-digit product format
858180002
Labeler code
85818
Product ID
85818-002_5695b716-649b-4558-952a-64a6b0be3079
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.Johnes 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
85818-002-01Dr.Johnes SKIN TAG REMOVER10 mL in 1 TUBESOLUTION102
85818-002-02Dr.Johnes SKIN TAG REMOVER9 mL in 1 TUBESOLUTION92
85818-002-03Dr.Johnes SKIN TAG REMOVER8 mL in 1 TUBESOLUTION82
85818-002-04Dr.Johnes SKIN TAG REMOVER7 mL in 1 TUBESOLUTION72

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312881salicylic acid 17 % Topical SolutionPSNb731c55e-31ee-429f-8432-fac7c5718d832
312881salicylic acid 170 MG/ML Topical SolutionSCDb731c55e-31ee-429f-8432-fac7c5718d832
312881salicylic acid 17 % Topical SolutionSYb731c55e-31ee-429f-8432-fac7c5718d832

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85818-002-018581800020110 mL in 1 TUBE (85818-002-01) 10 ml2025-06-02NoNoHistorical
85818-002-02858180002029 mL in 1 TUBE (85818-002-02) 9 ml2025-06-02NoNoHistorical
85818-002-03858180002038 mL in 1 TUBE (85818-002-03) 8 ml2025-06-02NoNoHistorical
85818-002-04858180002047 mL in 1 TUBE (85818-002-04) 7 ml2025-06-02NoNoHistorical