DOCOSANOL

Product NDC
51316-763
11-digit product format
513160763
Labeler code
51316
Product ID
51316-763_a5f62764-d8f4-4d2e-8fa1-cd05b61cc48f
Type
HUMAN OTC DRUG
Nonproprietary name
DOCOSANOL
Dosage form
CREAM
Route
TOPICAL
Labeler
CVS Pharmacy, Inc.
Application
ANDA215839
Marketing category
ANDA
Marketing start
2024-05-23
Substance
DOCOSANOL
Active strength
100 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DOCOSANOL
Listing expiration
2027-12-31

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
51316-763-02DOCOSANOL2 g in 1 TUBECREAM25
51316-763-02DOCOSANOL1 in 1 PACKAGECREAM15
51316-763-03DOCOSANOL2 in 1 PACKAGECREAM25
51316-763-03DOCOSANOL2 g in 1 TUBECREAM25
51316-763-04DOCOSANOL2 g in 1 TUBECREAM25
51316-763-04DOCOSANOL1 in 1 PACKAGECREAM15
51316-763-62DOCOSANOL2 g in 1 BOTTLE, PUMPCREAM25
51316-763-62DOCOSANOL1 in 1 PACKAGECREAM15
51316-763-64DOCOSANOL2 g in 1 BOTTLE, PUMPCREAM25
51316-763-64DOCOSANOL1 in 1 PACKAGECREAM15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-763DOCOSANOL CREAM [CVS PHARMACY, INC.]4Current NDC, Legacy NDC, 10 package rows20240524_336b515c-5e7b-4ece-a94f-f8d8e9ce6a7b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSN336b515c-5e7b-4ece-a94f-f8d8e9ce6a7b5
797534docosanol 100 MG/ML Topical CreamSCD336b515c-5e7b-4ece-a94f-f8d8e9ce6a7b5
797534docosanol 10 % Topical CreamSY336b515c-5e7b-4ece-a94f-f8d8e9ce6a7b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51316-763-02513160763021 TUBE in 1 PACKAGE (51316-763-02) / 2 g in 1 TUBE1 tube2024-05-230000-00-00NoNoCurrent
51316-763-03513160763032 TUBE in 1 PACKAGE (51316-763-03) / 2 g in 1 TUBE2 tube2024-05-23NoNoCurrent
51316-763-04513160763041 TUBE in 1 PACKAGE (51316-763-04) / 2 g in 1 TUBE1 tube2024-05-230000-00-00NoNoCurrent
51316-763-62513160763621 BOTTLE, PUMP in 1 PACKAGE (51316-763-62) / 2 g in 1 BOTTLE, PUMP2024-05-23NoNoCurrent
51316-763-64513160763641 BOTTLE, PUMP in 1 PACKAGE (51316-763-64) / 2 g in 1 BOTTLE, PUMP2024-05-230000-00-00NoNoCurrent