Home Applications 208754 Application 208754
Type ANDA
Sponsor P AND L Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DOCOSANOL DOCOSANOL CREAM;TOPICAL 10% No No
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…
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 2 · 105 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0135-0300 ABREVA docosanol GlaxoSmithKline Consumer Healthcare Holdings (US) LLC ANDA Current 0135-0300 ABREVA docosanol GlaxoSmithKline Consumer Healthcare Holdings (US) LLC ANDA Current 0363-2981 Docosanol Docosanol Walgreens ANDA Current 0363-2981 Docosanol Docosanol Walgreens ANDA Current 0363-2981 Docosanol Docosanol Walgreens ANDA Current 0363-2981 Docosanol Docosanol Walgreens ANDA Current 0363-2981 Docosanol Docosanol Walgreen Company ANDA Current 0363-2981 Docosanol Docosanol Walgreens ANDA Current 0363-9220 Cold Sore Fever Blister Treatment Docosanol Walgreens ANDA Current 0363-9220 Cold Sore Fever Blister Treatment Docosanol Walgreens ANDA Current 0363-9222 Cold Sore Fever Blister Treatment Docosanol Walgreens ANDA Current 0363-9222 Cold Sore Fever Blister Treatment Docosanol Walgreens ANDA Current 0363-9222 Cold Sore Fever Blister Treatment Docosanol Walgreens ANDA Current 0363-9222 Cold Sore Fever Blister Treatment Docosanol Walgreens ANDA Current 0363-9222 Cold Sore Fever Blister Treatment Docosanol Walgreens ANDA Current 0472-2981 Docosanol Docosanol Actavis Pharma, Inc. ANDA Current 0472-2981 Docosanol Docosanol Actavis Pharma, Inc. ANDA Current 0472-2981 Docosanol Docosanol Actavis Pharma, Inc. ANDA Current 0591-2981 Docosanol Docosanol Actavis Pharma, Inc. ANDA Current 0591-2981 Docosanol Docosanol Actavis Pharma, Inc. ANDA Current 0591-2981 Docosanol Docosanol Actavis Pharma, Inc. ANDA Current 0591-2981 Docosanol Docosanol Actavis Pharma, Inc. ANDA Current 11673-846 Cold Sore Fever Blister Treatment Docosanol TARGET Corporation ANDA Current 11673-846 Cold Sore Fever Blister Treatment Docosanol TARGET Corporation ANDA Current 11673-926 Cold Sore Fever Blister Treatment Docosanol TARGET Corporation ANDA Current 11673-926 Cold Sore Fever Blister Treatment Docosanol TARGET Corporation ANDA Current 11673-926 Cold Sore Fever Blister Treatment Docosanol TARGET Corporation ANDA Current 11822-0951 Cold Sore Fever Blister Treatment Docosanol Rite Aid Corporation ANDA Current 11822-0951 Cold Sore Fever Blister Treatment Docosanol Rite Aid Corporation ANDA Current 11822-0951 Cold Sore Fever Blister Treatment Docosanol Rite Aid Corporation ANDA Current 11822-3927 Cold Sore Fever Blister Treatment Docosanol Rite Aid Corporation ANDA Current 11822-3927 Cold Sore Fever Blister Treatment Docosanol Rite Aid Corporation ANDA Current 11822-3927 Cold Sore Fever Blister Treatment Docosanol Rite Aid Corporation ANDA Current 11822-3951 Cold Sore Fever Blister Treatment Docosanol Rite Aid Corporation ANDA Current 11822-3951 Cold Sore Fever Blister Treatment Docosanol Rite Aid Corporation ANDA Current 11822-3977 Cold Sore Fever Blister Treatment Docosanol Rite Aid Corporation ANDA Current 11822-4763 Cold Sore Fever Blister Treatment Docosanol Rite Aid Corporation ANDA Current 21130-422 Docosanol Docosanol Safeway, Inc. ANDA Current 21130-422 Docosanol Docosanol Safeway, Inc. ANDA Current 21130-422 Docosanol Docosanol Safeway, Inc. ANDA Current 21130-823 Cold Sore Fever Blister Treatment Docosanol Safeway, Inc. ANDA Current 21130-823 Cold Sore Fever Blister Treatment Docosanol Safeway, Inc. ANDA Current 30142-322 Cold Sore Fever Blister Docosanol The Kroger Co. ANDA Current 30142-322 Cold Sore Fever Blister Docosanol The Kroger Co. ANDA Current 30142-322 Cold Sore Fever Blister Docosanol The Kroger Co. ANDA Current 30142-981 Cold Sore Fever Blister Treatment Docosanol The Kroger Co. ANDA Current 30142-981 Cold Sore Fever Blister Treatment Docosanol The Kroger Co. ANDA Current 37808-223 Cold Sore Fever Blister Docosanol H E B ANDA Current 37808-223 Cold Sore Fever Blister Docosanol H E B ANDA Current 37808-229 Cold Sore Treatment Docosanol H E B ANDA Current 37808-229 Cold Sore Treatment Docosanol H E B ANDA Current 37808-229 Cold Sore Treatment Docosanol H E B ANDA Current 41163-722 Docosanol Docosanol EQUALINE (SuperValu) ANDA Current 41163-722 Docosanol Docosanol EQUALINE (SuperValu) ANDA Current 41163-722 Docosanol Docosanol EQUALINE (SuperValu) ANDA Current 41163-724 Docosanol Docosanol EQUALINE (SuperValu) ANDA Current 41163-724 Docosanol Docosanol EQUALINE (SuperValu) ANDA Current 41250-867 Docosanol Docosanol MEIJER, INC. ANDA Current 41250-867 Docosanol Docosanol MEIJER, INC. ANDA Current 41250-932 Docosanol Docosanol MEIJER, INC. ANDA Current 41250-932 Docosanol Docosanol MEIJER, INC. ANDA Current 46122-624 Docosanol Docosanol AmerisourceBergen (Good Neighbor Pharmacy) 46122 ANDA Current 46122-624 Docosanol Docosanol AmerisourceBergen (Good Neighbor Pharmacy) 46122 ANDA Current 46122-681 Docosanol Docosanol AmerisourceBergen (Good Neighbor Pharmacy) 46122 ANDA Current 46122-681 Docosanol Docosanol AmerisourceBergen (Good Neighbor Pharmacy) 46122 ANDA Current 46122-681 Docosanol Docosanol AmerisourceBergen (Good Neighbor Pharmacy) 46122 ANDA Current 49035-259 Docosanol Docosanol EQUATE (Wal-Mart Stores, Inc.) ANDA Current 49035-259 Docosanol Docosanol EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) ANDA Current 49035-259 Docosanol Docosanol EQUATE (Wal-Mart Stores, Inc.) ANDA Current 55301-877 Docosanol Docosanol AAFES/Your Military Exchanges ANDA Current 55301-877 Docosanol Docosanol AAFES/Your Military Exchanges ANDA Current 55301-922 Docosanol Docosanol AAFES/Your Military Exchanges ANDA Current 55301-922 Docosanol Docosanol AAFES/Your Military Exchanges ANDA Current 55301-922 Docosanol Docosanol AAFES/Your Military Exchanges ANDA Current 55910-722 Docosanol Docosanol Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) ANDA Current 55910-722 Docosanol Docosanol Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) ANDA Current 55910-963 Cold Sore Fever Blister Treatment Docosanol Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) ANDA Current 59726-924 Cold Sore Treatment Docosanol P & L Development, LLC ANDA Current 59726-924 Cold Sore Treatment Docosanol P & L Development, LLC ANDA Current 61269-981 DOCOSANOL DOCOSANOL H2-Pharma, LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 56857 ORIG 2018-12-20