FDA.reportPublic FDA data

Cold Sore Treatment

Product NDC
37808-229
11-digit product format
378080229
Labeler code
37808
Product ID
37808-229_362f386b-fa5f-4e04-a891-1b11ef714c81
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
H E B
Application
ANDA208754
Marketing category
ANDA
Marketing start
2020-06-30
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37808-229-072023-10-12C16284748780-1f386c64a-1b6e-0266-e053-dadaa90a7c1aDocosanol Cream, 10%
37808-229-142023-10-12C16284748780-1f386c64a-1b6e-0266-e053-dadaa90a7c1aDocosanol Cream, 10%
37808-229-072023-01-30C16284748780-1f386c64a-1b6e-0266-e053-dadaa90a7c1aDocosanol Cream, 10%
37808-229-142023-01-30C16284748780-1f386c64a-1b6e-0266-e053-dadaa90a7c1aDocosanol Cream, 10%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-229-07Cold Sore Treatment2 g in 1 TUBECREAM24
37808-229-07Cold Sore Treatment1 in 1 PACKAGECREAM14
37808-229-14Cold Sore Treatment2 in 1 PACKAGECREAM24
37808-229-14Cold Sore Treatment2 g in 1 TUBECREAM24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-229COLD SORE TREATMENT (DOCOSANOL) CREAM [H E B]4Current NDC, Legacy NDC, 4 package rows20231013_a94bc3d7-3bc5-4ed6-9bc9-46df1e2c3c2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSNa94bc3d7-3bc5-4ed6-9bc9-46df1e2c3c2d4
797534docosanol 100 MG/ML Topical CreamSCDa94bc3d7-3bc5-4ed6-9bc9-46df1e2c3c2d4
797534docosanol 10 % Topical CreamSYa94bc3d7-3bc5-4ed6-9bc9-46df1e2c3c2d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-229-07378080229071 TUBE in 1 PACKAGE (37808-229-07) / 2 g in 1 TUBE1 tube2020-06-300000-00-00NoNoCurrent
37808-229-14378080229142 TUBE in 1 PACKAGE (37808-229-14) / 2 g in 1 TUBE2 tube2020-06-300000-00-00NoNoCurrent