DOCOSANOL

Product NDC
46122-800
11-digit product format
461220800
Labeler code
46122
Product ID
46122-800_d6559957-0082-42b1-a43d-7c92cbd8b1a8
Type
HUMAN OTC DRUG
Nonproprietary name
DOCOSANOL
Dosage form
CREAM
Route
TOPICAL
Labeler
Amerisource Bergen
Application
ANDA217090
Marketing category
ANDA
Marketing start
2024-10-01
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
46122-800-36DOCOSANOL2 g in 1 TUBECREAM21
46122-800-36DOCOSANOL1 in 1 PACKAGECREAM11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-800-36GM - Gram46122-800987198da-f685-4da4-8bc3-30376280d0ce12025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-800DOCOSANOL CREAM [AMERISOURCE BERGEN]1Current NDC, 2 package rows20241009_d6559957-0082-42b1-a43d-7c92cbd8b1a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSNd6559957-0082-42b1-a43d-7c92cbd8b1a81
797534docosanol 100 MG/ML Topical CreamSCDd6559957-0082-42b1-a43d-7c92cbd8b1a81
797534docosanol 10 % Topical CreamSYd6559957-0082-42b1-a43d-7c92cbd8b1a81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46122-800-36461220800361 TUBE in 1 PACKAGE (46122-800-36) / 2 g in 1 TUBE1 tube2024-10-01NoNoCurrent