FDA.reportPublic FDA data

Docosanol

Product NDC
51672-1406
11-digit product format
516721406
Labeler code
51672
Product ID
51672-1406_468c0871-aa4c-71f5-e063-6394a90a86d9
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA214454
Marketing category
ANDA
Marketing start
2023-10-26
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
Docosanol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCOSANOL100 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9G1OE216XY
Rxcui797534

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1406-2Docosanol2 g in 1 TUBECREAM29
51672-1406-2Docosanol2 in 1 PACKAGECREAM29
51672-1406-3Docosanol2 g in 1 TUBECREAM29
51672-1406-3Docosanol1 in 1 PACKAGECREAM19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1406DOCOSANOL CREAM [TARO PHARMACEUTICALS U.S.A., INC.]6Current NDC, 4 package rows20241128_5079b009-7f34-4d34-8f01-821365f04ca2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSN5079b009-7f34-4d34-8f01-821365f04ca29
797534docosanol 100 MG/ML Topical CreamSCD5079b009-7f34-4d34-8f01-821365f04ca29
797534docosanol 10 % Topical CreamSY5079b009-7f34-4d34-8f01-821365f04ca29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51672-1406-2516721406022 TUBE in 1 PACKAGE (51672-1406-2) / 2 g in 1 TUBE2 tube2023-10-26NoNoCurrent
51672-1406-3516721406031 TUBE in 1 PACKAGE (51672-1406-3) / 2 g in 1 TUBE1 tube2023-10-26NoNoCurrent