Cold Sore Treatment

Product NDC
59726-112
11-digit product format
597260112
Labeler code
59726
Product ID
59726-112_0ebd37a8-19cc-4ac3-b73a-11ad38a0e2e2
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
P & L Development, LLC
Application
ANDA212385
Marketing category
ANDA
Marketing start
2023-12-31
Marketing end
2027-12-31
Substance
DOCOSANOL
Active strength
100 mg/g
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cold Sore Treatment

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
59726-112-07Cold Sore Treatment2 g in 1 TUBECREAM23
59726-112-07Cold Sore Treatment1 in 1 PACKAGECREAM13
59726-112-14Cold Sore Treatment2 in 1 PACKAGECREAM23
59726-112-14Cold Sore Treatment2 g in 1 TUBECREAM23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-112COLD SORE TREATMENT (DOCOSANOL) CREAM [P & L DEVELOPMENT, LLC]2Current NDC, 4 package rows20231231_53cd18dc-bece-473e-a116-df6c88fe6fe7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSN53cd18dc-bece-473e-a116-df6c88fe6fe73
797534docosanol 100 MG/ML Topical CreamSCD53cd18dc-bece-473e-a116-df6c88fe6fe73
797534docosanol 10 % Topical CreamSY53cd18dc-bece-473e-a116-df6c88fe6fe73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59726-112-07597260112071 TUBE in 1 PACKAGE (59726-112-07) / 2 g in 1 TUBE1 tube2023-12-312027-08-31NoNoHistorical
59726-112-14597260112142 TUBE in 1 PACKAGE (59726-112-14) / 2 g in 1 TUBE2 tube2023-12-312027-12-31NoNoHistorical