DOCOSANOL

Product NDC
61269-981
11-digit product format
612690981
Labeler code
61269
Product ID
61269-981_eb9407e5-ced9-48f1-aecd-ae40906d50da
Type
HUMAN OTC DRUG
Nonproprietary name
DOCOSANOL
Dosage form
CREAM
Route
TOPICAL
Labeler
H2-Pharma, LLC
Application
ANDA208754
Marketing category
ANDA
Marketing start
2021-06-29
Marketing end
0000-00-00
Substance
DOCOSANOL
Active strength
100 mg/g
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61269-981-35GM - Gram61269-9813e51d098-b6b3-4f41-9a41-0e9befe0b50f12021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61269-981DOCOSANOL CREAM [H2-PHARMA, LLC]3Legacy NDC20250413_a921a653-aedd-43c2-b84f-429a4aada79a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61269-981-35612690981351 TUBE in 1 PACKAGE (61269-981-35) > 2 g in 1 TUBE1 tube2021-06-290000-00-00NoNoCurrent