Home NDC 41415-660 Docosanol
Product NDC 41415-660
11-digit product format 414150660
Labeler code 41415
Product ID 41415-660_39fe953e-8139-6475-e063-6294a90a351f
Type HUMAN OTC DRUG
Nonproprietary name Docosanol
Dosage form CREAM
Route TOPICAL
Labeler Publix Super Markets Inc.
Application ANDA214454
Marketing category ANDA
Marketing start 2025-07-15
Substance DOCOSANOL
Active strength 100 mg/g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A214454-001 DOCOSANOL DOCOSANOL 10% CREAM / TOPICAL 2023-10-26
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 2026-02-19 14:30 UTC 2026-02 A214454-001 DOCOSANOL 10% CREAM / TOPICAL 2023-10-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214454-001 DOCOSANOL 10% CREAM / TOPICAL 2023-10-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214454-001 DOCOSANOL 10% CREAM / TOPICAL 2023-10-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214454-001 DOCOSANOL 10% CREAM / TOPICAL 2023-10-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214454-001 DOCOSANOL 10% CREAM / TOPICAL 2023-10-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214454-001 DOCOSANOL 10% CREAM / TOPICAL 2023-10-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214454-001 DOCOSANOL 10% CREAM / TOPICAL 2023-10-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214454-001 DOCOSANOL 10% CREAM / TOPICAL 2023-10-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214454-001 DOCOSANOL 10% CREAM / TOPICAL 2023-10-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214454-001 DOCOSANOL 10% CREAM / TOPICAL 2023-10-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214454-001 DOCOSANOL 10% CREAM / TOPICAL 2023-10-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214454-001 DOCOSANOL 10% CREAM / TOPICAL 2023-10-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214454-001 DOCOSANOL 10% CREAM / TOPICAL 2023-10-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214454-001 DOCOSANOL 10% CREAM / TOPICAL 2023-10-26 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214454-001 DOCOSANOL 10% CREAM / TOPICAL 2023-10-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214454-001 DOCOSANOL 10% CREAM / TOPICAL 2023-10-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214454-001 DOCOSANOL 10% CREAM / TOPICAL 2023-10-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214454-001 DOCOSANOL 10% CREAM / TOPICAL 2023-10-26 a72a2bbeb626…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214454-001 DOCOSANOL 10% CREAM / TOPICAL 2023-10-26 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Docosanol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOCOSANOL 100 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9G1OE216XY Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 797534 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 41415-660-03 Docosanol 1 in 1 PACKAGE CREAM 1 2 41415-660-03 Docosanol 2 g in 1 TUBE CREAM 2 2
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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 41415-660-03 41415066003 1 TUBE in 1 PACKAGE (41415-660-03) / 2 g in 1 TUBE 1 tube 2025-07-15 No No Current