Cold Sore Fever Blister Treatment

Product NDC
79481-0065
11-digit product format
794810065
Labeler code
79481
Product ID
79481-0065_46990e21-8c4c-4bc2-91e8-350aced1ceff
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
Meijer Distribution Inc.
Application
ANDA212385
Marketing category
ANDA
Marketing start
2023-07-07
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 Treatment
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
79481-0065-7Cold Sore Fever Blister Treatment2 g in 1 BOTTLE, PUMPCREAM22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-0065COLD SORE FEVER BLISTER TREATMENT (DOCOSANOL) CREAM [MEIJER DISTRIBUTION INC.]2Current NDC, 1 package rows20230720_f00f46a0-2746-4538-93b6-09930d9c110c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSNf00f46a0-2746-4538-93b6-09930d9c110c2
797534docosanol 100 MG/ML Topical CreamSCDf00f46a0-2746-4538-93b6-09930d9c110c2
797534docosanol 10 % Topical CreamSYf00f46a0-2746-4538-93b6-09930d9c110c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79481-0065-7794810065072 g in 1 BOTTLE, PUMP (79481-0065-7) 2 g2023-07-07NoNoCurrent