Home NDC 43598-044 Docosanol
Product NDC 43598-044
11-digit product format 435980044
Labeler code 43598
Product ID 43598-044_0fadcff9-9823-e9cf-209a-dc12dac163f5
Type HUMAN OTC DRUG
Nonproprietary name docosanol
Dosage form CREAM
Route TOPICAL
Labeler Dr.Reddys' Laboratories Inc
Application ANDA214613
Marketing category ANDA
Marketing start 2026-09-23
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214613-001 DOCOSANOL DOCOSANOL 10% CREAM / TOPICAL 2025-10-03
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 2026-09-14 22:38:34 2026-08 A214613-001 DOCOSANOL 10% CREAM / TOPICAL 2025-10-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214613-001 DOCOSANOL 10% CREAM / TOPICAL 2025-10-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214613-001 DOCOSANOL 10% CREAM / TOPICAL 2025-10-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214613-001 DOCOSANOL 10% CREAM / TOPICAL 2025-10-03 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214613-001 DOCOSANOL 10% CREAM / TOPICAL 2025-10-03 a50c72e98297…
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 43598-044-02 43598004402 1 TUBE in 1 CARTON (43598-044-02) / 2 g in 1 TUBE 1 tube 2026-09-23 No No Current 43598-044-33 43598004433 3 TUBE in 1 CARTON (43598-044-33) / 2 g in 1 TUBE 3 tube 2026-09-23 No No Current