Home NDC 69452-550 Docosanol
Product NDC 69452-550
11-digit product format 694520550
Labeler code 69452
Product ID 69452-550_5e856d3e-a0b2-0d3d-e063-6394a90ac413
Type HUMAN OTC DRUG
Nonproprietary name Docosanol
Dosage form CREAM
Route TOPICAL
Labeler BIONPHARMA INC.
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 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A220017-001 DOCOSANOL DOCOSANOL 10% CREAM / TOPICAL 2026-07-31
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A220017-001 DOCOSANOL 10% CREAM / TOPICAL 2026-07-31 c2088c7a36db…2026-09-14 22:38:34 2026-08 A220017-001 DOCOSANOL 10% CREAM / TOPICAL 2026-07-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A220017-001 DOCOSANOL 10% CREAM / TOPICAL 2026-07-31 caaa826d4ba7…
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 Ingredient Strength DOCOSANOL 100 mg/g
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69452-550-02 69452055002 2 TUBE in 1 CARTON (69452-550-02) / 2 g in 1 TUBE 2 tube 2026-10-10 No No Current 69452-550-61 69452055061 1 BOTTLE, PUMP in 1 CARTON (69452-550-61) / 2 g in 1 BOTTLE, PUMP 2026-10-10 No No Current