Docosanol

Product NDC
49035-259
11-digit product format
490350259
Labeler code
49035
Product ID
49035-259_75dc0541-9413-4969-aaed-d535241865bc
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
Application
ANDA208754
Marketing category
ANDA
Marketing start
2020-01-06
Marketing end
2027-01-31
Substance
DOCOSANOL
Active strength
100 mg/g
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Docosanol

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCOSANOL100 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9G1OE216XY
Rxcui797534

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-259-35Docosanol2 g in 1 TUBECREAM27
49035-259-35Docosanol1 in 1 PACKAGECREAM17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-259-35GM - Gram49035-259e4faf837-1a0e-41ba-b236-e873ca8b41c612024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-259DOCOSANOL CREAM [EQUATE (WAL-MART STORES, INC.) (SEE ALSO WAL-MART INC)]5Current NDC, Legacy NDC, 2 package rows20221208_b62ee383-631a-4220-8dfd-48ec67bb0a63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSNb62ee383-631a-4220-8dfd-48ec67bb0a637
797534docosanol 100 MG/ML Topical CreamSCDb62ee383-631a-4220-8dfd-48ec67bb0a637
797534docosanol 10 % Topical CreamSYb62ee383-631a-4220-8dfd-48ec67bb0a637

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-259-35490350259351 TUBE in 1 PACKAGE (49035-259-35) / 2 g in 1 TUBE1 tube2020-04-252027-01-31NoNoCurrent