Cold Sore Fever Blister Treatment

Product NDC
55910-550
11-digit product format
559100550
Labeler code
55910
Product ID
55910-550_c0d191a9-3091-4f42-aea1-04c5a9dfede4
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
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
55910-550-07Cold Sore Fever Blister Treatment2 g in 1 BOTTLE, PUMPCREAM23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-550COLD SORE FEVER BLISTER TREATMENT (DOCOSANOL) CREAM [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]3Current NDC, 1 package rows20230708_edeae56f-6061-45a7-a79d-845a60306799.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSNedeae56f-6061-45a7-a79d-845a603067993
797534docosanol 100 MG/ML Topical CreamSCDedeae56f-6061-45a7-a79d-845a603067993
797534docosanol 10 % Topical CreamSYedeae56f-6061-45a7-a79d-845a603067993

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55910-550-07559100550072 g in 1 BOTTLE, PUMP (55910-550-07) 2 g2023-07-07NoNoCurrent