SEYTU Spot

Product NDC
84271-002
11-digit product format
842710002
Labeler code
84271
Product ID
84271-002_68252aa0-36cd-4380-8898-16a5e4731866
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
GEL
Route
TOPICAL
Labeler
Omnilife USA, Inc.
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-01
Substance
SALICYLIC ACID
Active strength
2 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID2 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO414PZ4LPZ
Rxcui346298

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84271-002-00SEYTU Spot1 in 1 CARTONGEL11
84271-002-00SEYTU Spot15 mL in 1 TUBEGEL151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84271-002SEYTU SPOT (SALICYLIC ACID) GEL [OMNILIFE USA, INC.]1Current NDC, 2 package rows20241202_68252aa0-36cd-4380-8898-16a5e4731866.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
346298salicylic acid 2 % Topical GelPSN68252aa0-36cd-4380-8898-16a5e47318661
346298salicylic acid 0.02 MG/MG Topical GelSCD68252aa0-36cd-4380-8898-16a5e47318661
346298salicylic acid 2 % Topical GelSY68252aa0-36cd-4380-8898-16a5e47318661

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84271-002-00842710002001 TUBE in 1 CARTON (84271-002-00) / 15 mL in 1 TUBE1 tube2024-12-01NoNoCurrent