Cold Sore Treatment

Product NDC
59726-924
11-digit product format
597260924
Labeler code
59726
Product ID
59726-924_3a93fdcf-bd3a-48ed-9821-48947cc2ac2a
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
P & L Development, LLC
Application
ANDA208754
Marketing category
ANDA
Marketing start
2021-05-28
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCOSANOL100 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9G1OE216XY
Rxcui797534

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59726-924-07Cold Sore Treatment1 in 1 PACKAGECREAM12
59726-924-07Cold Sore Treatment2 g in 1 TUBECREAM22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-924COLD SORE TREATMENT (DOCOSANOL) CREAM [P & L DEVELOPMENT, LLC]2Current NDC, Legacy NDC, 2 package rows20221019_15d1a6c5-4a61-48f3-b45e-a7e34cbeb294.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSN15d1a6c5-4a61-48f3-b45e-a7e34cbeb2942
797534docosanol 100 MG/ML Topical CreamSCD15d1a6c5-4a61-48f3-b45e-a7e34cbeb2942
797534docosanol 10 % Topical CreamSY15d1a6c5-4a61-48f3-b45e-a7e34cbeb2942

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59726-924-07597260924071 TUBE in 1 PACKAGE (59726-924-07) / 2 g in 1 TUBE1 tube2021-05-280000-00-00NoNoCurrent