Cold Sore Fever Blister

Product NDC
59726-221
11-digit product format
597260221
Labeler code
59726
Product ID
59726-221_cd6a4e71-432e-4c1d-8410-b7d5002e0108
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
P & L Development, LLC
Application
ANDA212385
Marketing category
ANDA
Marketing start
2025-01-31
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 Fever Blister
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
59726-221-07Cold Sore Fever Blister1 in 1 PACKAGECREAM13
59726-221-07Cold Sore Fever Blister2 g in 1 TUBECREAM23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-221COLD SORE FEVER BLISTER (DOCOSANOL) CREAM [P & L DEVELOPMENT, LLC]3Current NDC, 2 package rows20250131_a71d2510-03c7-4724-b77b-12dd6451eb98.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSNa71d2510-03c7-4724-b77b-12dd6451eb983
797534docosanol 100 MG/ML Topical CreamSCDa71d2510-03c7-4724-b77b-12dd6451eb983
797534docosanol 10 % Topical CreamSYa71d2510-03c7-4724-b77b-12dd6451eb983

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59726-221-07597260221071 TUBE in 1 PACKAGE (59726-221-07) / 2 g in 1 TUBE1 tube2025-01-31NoNoCurrent