Home NDC 55301-877 Docosanol
Product NDC 55301-877
11-digit product format 553010877
Labeler code 55301
Product ID 55301-877_34a6014c-9c19-d22d-e063-6394a90ac32e
Type HUMAN OTC DRUG
Nonproprietary name Docosanol
Dosage form CREAM
Route TOPICAL
Labeler AAFES/Your Military Exchanges
Application ANDA208754
Marketing category ANDA
Marketing start 2021-07-01
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 A208754-001 DOCOSANOL DOCOSANOL 10% CREAM / TOPICAL 2018-11-19
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.
Product history page 1 of 2 · 43 observed 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 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 f41ea6bd6efb…
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
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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55301-877-07 Docosanol 1 in 1 PACKAGE CREAM 1 4 55301-877-07 Docosanol 2 g in 1 TUBE CREAM 2 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55301-877 DOCOSANOL CREAM [AAFES/YOUR MILITARY EXCHANGES] 4 Current NDC, Legacy NDC, 2 package rows 20250510_b056ad46-bf48-4468-8b65-9e80176b6c52.zip
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 2 of 2 · 30 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55301-877-07 55301087707 1 TUBE in 1 PACKAGE (55301-877-07) / 2 g in 1 TUBE 1 tube 2021-07-01 0000-00-00 No No Current