FDA.reportPublic FDA data

Docosanol

Product NDC
84725-001
11-digit product format
847250001
Labeler code
84725
Product ID
84725-001_cbd03a44-aac9-4ae2-8275-d1967ca22043
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
KLM Laboratories Private Limited
Application
ANDA220017
Marketing category
ANDA
Marketing start
2026-09-08
Substance
DOCOSANOL
Active strength
100 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A220017-001DOCOSANOLDOCOSANOL10%CREAM / TOPICAL2026-07-31

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A220017-001DOCOSANOL10%CREAM / TOPICAL2026-07-3184e616aacf4f…
2026-08-18 06:07:402026-07A220017-001DOCOSANOL10%CREAM / TOPICAL2026-07-31caaa826d4ba7…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCOSANOL100 mg/g

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DocosanolDOCOSANOLKLM Laboratories Private Limited5783edbf-2ce6-4b7e-8df3-2e421c63d0e82026-09-08WarningsExact identifier
application applno (ANDA): 220017
application number: ANDA220017
ndc (product): 84725-001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84725-001-01847250001011 TUBE in 1 PACKAGE (84725-001-01) / 2 g in 1 TUBE1 tube2026-09-08NoNoCurrent
84725-001-02847250001021 BOTTLE, PUMP in 1 PACKAGE (84725-001-02) / 2 g in 1 BOTTLE, PUMP2026-09-08NoNoCurrent
84725-001-09847250001092 TUBE in 1 PACKAGE (84725-001-09) / 2 g in 1 TUBE2 tube2026-10-01NoNoCurrent