Cold Sore Treatment

Product NDC
59726-922
11-digit product format
597260922
Labeler code
59726
Product ID
59726-922_661f138d-c81b-4eb5-b919-25c09e6d1bf8
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
P & L Development, LLC
Application
ANDA212385
Marketing category
ANDA
Marketing start
2023-07-15
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
59726-922-07Cold Sore Treatment1 in 1 BOTTLE, PUMPCREAM13
59726-922-07Cold Sore Treatment2 g in 1 TUBECREAM23
59726-922-14Cold Sore Treatment2 in 1 PACKAGECREAM23
59726-922-14Cold Sore Treatment2 g in 1 TUBECREAM23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-922COLD SORE TREATMENT (DOCOSANOL) CREAM [P & L DEVELOPMENT, LLC]2Current NDC, 4 package rows20230811_20d2480b-44b5-499f-8670-01d6a4e4cb34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSN20d2480b-44b5-499f-8670-01d6a4e4cb343
797534docosanol 100 MG/ML Topical CreamSCD20d2480b-44b5-499f-8670-01d6a4e4cb343
797534docosanol 10 % Topical CreamSY20d2480b-44b5-499f-8670-01d6a4e4cb343

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59726-922-07597260922071 TUBE in 1 BOTTLE, PUMP (59726-922-07) / 2 g in 1 TUBE1 tube2023-07-15NoNoCurrent
59726-922-14597260922142 TUBE in 1 PACKAGE (59726-922-14) / 2 g in 1 TUBE2 tube2023-07-15NoNoCurrent