Cold Sore Fever Blister Treatment

Product NDC
68016-344
11-digit product format
680160344
Labeler code
68016
Product ID
68016-344_2737823b-e8eb-49e3-b898-1def813fea10
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
Chain Drug Consortium, LLC
Application
ANDA208754
Marketing category
ANDA
Marketing start
2021-06-01
Marketing end
2026-12-31
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 Fever Blister Treatment

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCOSANOL100 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9G1OE216XY
Rxcui797534

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-344-072023-10-06C16284748780-1f386c649-b363-0266-e053-dadaa90a7c1aDocosanol Cream, 10%
68016-344-072023-01-30C16284748780-1f386c649-b363-0266-e053-dadaa90a7c1aDocosanol Cream, 10%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-344-07Cold Sore Fever Blister Treatment2 g in 1 TUBECREAM25
68016-344-07Cold Sore Fever Blister Treatment1 in 1 PACKAGECREAM15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-344COLD SORE FEVER BLISTER TREATMENT (DOCOSANOL) CREAM [CHAIN DRUG CONSORTIUM, LLC]4Current NDC, Legacy NDC, 2 package rows20231010_86406372-9e95-43b9-b275-5661141a085b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSN86406372-9e95-43b9-b275-5661141a085b5
797534docosanol 100 MG/ML Topical CreamSCD86406372-9e95-43b9-b275-5661141a085b5
797534docosanol 10 % Topical CreamSY86406372-9e95-43b9-b275-5661141a085b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-344-07680160344071 TUBE in 1 PACKAGE (68016-344-07) / 2 g in 1 TUBE1 tube2021-06-012026-12-31NoNoCurrent