Cold Sore Treatment Docosanol

Product NDC
10157-2124
11-digit product format
101572124
Labeler code
10157
Product ID
10157-2124_75847eb8-3765-4c32-8c4c-f39b22d3aab3
Type
HUMAN OTC DRUG
Nonproprietary name
DOCOSANOL
Dosage form
CREAM
Route
TOPICAL
Labeler
Blistex Inc.
Application
ANDA217090
Marketing category
ANDA
Marketing start
2025-05-01
Substance
DOCOSANOL
Active strength
100 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cold Sore Treatment Docosanol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCOSANOL100 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9G1OE216XY
Rxcui797534

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10157-2124-2Cold Sore Treatment Docosanol1 in 1 BLISTER PACKCREAM11
10157-2124-2Cold Sore Treatment Docosanol2 g in 1 TUBECREAM21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10157-2124COLD SORE TREATMENT DOCOSANOL (DOCOSANOL) CREAM [BLISTEX INC.]1Current NDC, 2 package rows20250501_bcdd51a9-210c-4d92-b67e-e3ac16c99812.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSNbcdd51a9-210c-4d92-b67e-e3ac16c998121
797534docosanol 100 MG/ML Topical CreamSCDbcdd51a9-210c-4d92-b67e-e3ac16c998121
797534docosanol 10 % Topical CreamSYbcdd51a9-210c-4d92-b67e-e3ac16c998121

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10157-2124-2101572124021 TUBE in 1 BLISTER PACK (10157-2124-2) / 2 g in 1 TUBE1 tube2025-05-01NoNoCurrent