Home NDC 0363-8980 Docosanol
Product NDC 0363-8980
11-digit product format 003638980
Labeler code 0363
Product ID 0363-8980_b08100e8-c54f-4124-85d3-e078602c868f
Type HUMAN OTC DRUG
Nonproprietary name Docosanol
Dosage form CREAM
Route TOPICAL
Labeler Walgreens
Application ANDA212385
Marketing category ANDA
Marketing start 2023-12-31
Marketing end 2027-12-31
Substance DOCOSANOL
Active strength 100 mg/g
NDC exclude flag No
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 A212385-001 DOCOSANOL DOCOSANOL 10% CREAM / TOPICAL 2022-10-07
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 A212385-001 DOCOSANOL 10% CREAM / TOPICAL 2022-10-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212385-001 DOCOSANOL 10% CREAM / TOPICAL 2022-10-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212385-001 DOCOSANOL 10% CREAM / TOPICAL 2022-10-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212385-001 DOCOSANOL 10% CREAM / TOPICAL 2022-10-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212385-001 DOCOSANOL 10% CREAM / TOPICAL 2022-10-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212385-001 DOCOSANOL 10% CREAM / TOPICAL 2022-10-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212385-001 DOCOSANOL 10% CREAM / TOPICAL 2022-10-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212385-001 DOCOSANOL 10% CREAM / TOPICAL 2022-10-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212385-001 DOCOSANOL 10% CREAM / TOPICAL 2022-10-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212385-001 DOCOSANOL 10% CREAM / TOPICAL 2022-10-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212385-001 DOCOSANOL 10% CREAM / TOPICAL 2022-10-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212385-001 DOCOSANOL 10% CREAM / TOPICAL 2022-10-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212385-001 DOCOSANOL 10% CREAM / TOPICAL 2022-10-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212385-001 DOCOSANOL 10% CREAM / TOPICAL 2022-10-07 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212385-001 DOCOSANOL 10% CREAM / TOPICAL 2022-10-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212385-001 DOCOSANOL 10% CREAM / TOPICAL 2022-10-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212385-001 DOCOSANOL 10% CREAM / TOPICAL 2022-10-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212385-001 DOCOSANOL 10% CREAM / TOPICAL 2022-10-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212385-001 DOCOSANOL 10% CREAM / TOPICAL 2022-10-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212385-001 DOCOSANOL 10% CREAM / TOPICAL 2022-10-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212385-001 DOCOSANOL 10% CREAM / TOPICAL 2022-10-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212385-001 DOCOSANOL 10% CREAM / TOPICAL 2022-10-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212385-001 DOCOSANOL 10% CREAM / TOPICAL 2022-10-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212385-001 DOCOSANOL 10% CREAM / TOPICAL 2022-10-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212385-001 DOCOSANOL 10% CREAM / TOPICAL 2022-10-07 f41ea6bd6efb…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212385-001 DOCOSANOL 10% CREAM / TOPICAL 2022-10-07 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Docosanol 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 0363-8980-07 Docosanol 2 g in 1 TUBE CREAM 2 4 0363-8980-07 Docosanol 1 in 1 PACKAGE CREAM 1 4 0363-8980-14 Docosanol 2 g in 1 TUBE CREAM 2 4 0363-8980-14 Docosanol 2 in 1 PACKAGE CREAM 2 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-8980 DOCOSANOL CREAM [WALGREENS] 3 Current NDC, 4 package rows 20240305_1500df4d-0c69-4590-a67f-d11edcccd90c.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 1 of 2 · 24 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cold Sore Fever Blister Treatment DOCOSANOL Sportpharm LLC e3e6c0b0-399f-41e4-9df9-109ee2917995 2026-07-12 Warnings Exact identifier application applno (ANDA): 212385 application number: ANDA212385 Cold Sore Fever Blister Treatment DOCOSANOL Walgreens 518bd432-f0d0-4fc4-944c-b9d1a01e2064 2026-07-09 Warnings Exact identifier application applno (ANDA): 212385 application number: ANDA212385 Cold Sore Treatment DOCOSANOL P & L Development, LLC 53cd18dc-bece-473e-a116-df6c88fe6fe7 2025-12-29 Warnings Exact identifier application applno (ANDA): 212385 application number: ANDA212385 Cold Sore Fever Blister Treatment DOCOSANOL Topco Associates 73348ce7-5b08-49ad-ba59-6f54887f819b 2025-12-29 Warnings Exact identifier application applno (ANDA): 212385 application number: ANDA212385 Docosanol DOCOSANOL Care One (Retail Business Services, LLC.) 9f31b742-4170-4219-80e3-2a5a71b3483e 2025-12-29 Warnings Exact identifier application applno (ANDA): 212385 application number: ANDA212385 Cold Sore Fever Blister Treatment DOCOSANOL Safeway, Inc. 85bfd33e-9404-4483-b76c-0ee519aad731 2025-12-29 Warnings Exact identifier application applno (ANDA): 212385 application number: ANDA212385 Cold Sore Fever Blister Treatment DOCOSANOL FSA Store Inc. (Caring Mills) fe67f56e-4c35-40cb-8a75-174a873f2900 2025-12-29 Warnings Exact identifier application applno (ANDA): 212385 application number: ANDA212385 Cold Sore Fever Blister DOCOSANOL H E B 71b2bb18-4a48-42c2-b03a-dccf581a0d97 2025-12-29 Warnings Exact identifier application applno (ANDA): 212385 application number: ANDA212385 Cold Sore Fever Blister Treatment DOCOSANOL Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 5ecf678b-d08a-4082-9d01-4468865a94b2 2025-12-29 Warnings Exact identifier application applno (ANDA): 212385 application number: ANDA212385 Cold Sore Fever Blister Treatment DOCOSANOL Strategic Sourcing Services LLC 8a6bb379-bc3a-4ad2-9ecd-8fe1870873d8 2025-12-29 Warnings Exact identifier application applno (ANDA): 212385 application number: ANDA212385 Cold Sore Fever Blister Treatment DOCOSANOL TARGET Corporation b332d558-bbe0-4d62-a51f-f07a228e6dca 2025-12-29 Warnings Exact identifier application applno (ANDA): 212385 application number: ANDA212385 Docosanol DOCOSANOL Walgreens 1500df4d-0c69-4590-a67f-d11edcccd90c 2025-12-29 Warnings Exact identifier application applno (ANDA): 212385 application number: ANDA212385 ndc (product): 0363-8980 Cold Sore Fever Blister Treatment DOCOSANOL WALMART INC. (see also Equate) fe56bf08-1efd-4996-a276-06b6039085f3 2025-12-29 Warnings Exact identifier application applno (ANDA): 212385 application number: ANDA212385 Cold Sore Treatment DOCOSANOL P & L Development, LLC 20d2480b-44b5-499f-8670-01d6a4e4cb34 2025-12-05 Warnings Exact identifier application applno (ANDA): 212385 application number: ANDA212385 Docosanol DOCOSANOL Encube Ethicals, Inc. 5b3137d3-c186-4c5d-89d2-ec5d1c3da8cd 2025-09-08 Warnings Exact identifier application applno (ANDA): 212385 application number: ANDA212385 DOCOSANOL DOCOSANOL H2-Pharma, LLC f0b3a78b-b14c-4869-ba3b-d04ffa62e1d5 2025-04-14 Warnings Exact identifier application applno (ANDA): 212385 application number: ANDA212385 Docosanol DOCOSANOL AAFES/Your Military Exchanges 11272b21-295d-49b3-83bf-5f71899340c5 2025-03-07 Warnings Exact identifier application applno (ANDA): 212385 application number: ANDA212385 Cold Sore Fever Blister DOCOSANOL P & L Development, LLC a71d2510-03c7-4724-b77b-12dd6451eb98 2025-01-03 Warnings Exact identifier application applno (ANDA): 212385 application number: ANDA212385 Cold Sore Fever Blister Treatment DOCOSANOL The Kroger Co. 07fc9c8d-dee7-4a69-bb7a-0f3001a4ebb3 2024-10-17 Warnings Exact identifier application applno (ANDA): 212385 application number: ANDA212385 Docosanol DOCOSANOL Safeway, Inc. d5ba34f8-42ab-4997-b06b-ea4e754b44d1 2024-08-21 Warnings Exact identifier application applno (ANDA): 212385 application number: ANDA212385
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 0363-8980-07 00363898007 1 TUBE in 1 PACKAGE (0363-8980-07) / 2 g in 1 TUBE 1 tube 2023-12-31 2027-12-31 No No Historical 0363-8980-14 00363898014 2 TUBE in 1 PACKAGE (0363-8980-14) / 2 g in 1 TUBE 2 tube 2023-12-31 2027-12-31 No No Historical