Cold Sore Fever Blister Treatment

Product NDC
55910-963
11-digit product format
559100963
Labeler code
55910
Product ID
55910-963_f2e98075-3b9a-4d4f-9d98-b37b0887f1f3
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Application
ANDA208754
Marketing category
ANDA
Marketing start
2022-09-15
Marketing end
2027-02-15
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 Fever Blister Treatment

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
55910-963-07Cold Sore Fever Blister Treatment1 in 1 PACKAGECREAM13
55910-963-07Cold Sore Fever Blister Treatment2 g in 1 TUBECREAM23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-963COLD SORE FEVER BLISTER TREATMENT (DOCOSANOL) CREAM [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]1Current NDC, Legacy NDC, 2 package rows20220929_4286c19b-8c81-40f6-8d97-cfebba87c174.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSN4286c19b-8c81-40f6-8d97-cfebba87c1743
797534docosanol 100 MG/ML Topical CreamSCD4286c19b-8c81-40f6-8d97-cfebba87c1743
797534docosanol 10 % Topical CreamSY4286c19b-8c81-40f6-8d97-cfebba87c1743

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-963-07559100963071 TUBE in 1 PACKAGE (55910-963-07) / 2 g in 1 TUBE1 tube2022-09-152027-02-15NoNoCurrent