DOCOSANOL
- Product NDC
- 71589-019
- Requested package NDC
- 71589-019-03
- 11-digit product format
- 715890019
- Labeler code
- 71589
- Product ID
- 71589-019_79d7df50-7ce1-4679-b638-224ae611969c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- DOCOSANOL
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Aleor Dermaceuticals Limited
- Application
- ANDA215839
- Marketing category
- ANDA
- Marketing start
- 2022-05-03
- Marketing end
- 0000-00-00
- Substance
- DOCOSANOL
- Active strength
- 100 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 71589-019 | 71589-019-03 | D | Discontinued by firm | 2026-08-17 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A215839-001 | DOCOSANOL | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 5c6f7cd8ea54… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | a50c72e98297… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 71589-019-01 | 2025-03-12 | Docosanol Cream, 10% |
| 71589-019-03 | 2025-03-12 | Docosanol Cream, 10% |
| 71589-019-01 | 2024-01-30 | Docosanol Cream, 10% |
| 71589-019-03 | 2024-01-30 | Docosanol Cream, 10% |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| DOCOSANOL | DOCOSANOL | CVS Pharmacy, Inc. | 336b515c-5e7b-4ece-a94f-f8d8e9ce6a7b | 2026-03-13 | Warnings | 215839 ANDA215839 |
| Docosanol | DOCOSANOL | Leader/ Cardinal Health 110, Inc. | ed18ecb7-70ce-4037-a738-6b159e364d62 | 2025-12-25 | Warnings | 215839 ANDA215839 |
| Docosanol | DOCOSANOL | Alembic Pharmaceuticals Limited | a87a077d-9b0e-490d-b4ac-26c7045828db | 2025-05-08 | Warnings | 215839 ANDA215839 |
| DOCOSANOL | DOCOSANOL | Rugby Laboratories | 6f8d6375-8188-42e9-a048-e8a554122ff3 | 2024-05-23 | Warnings | 215839 ANDA215839 |
| DOCOSANOL | DOCOSANOL | Cosette Pharmaceuticals, Inc. | ccbb5e6d-cb85-449c-a480-28225d744f4d | 2024-01-04 | Warnings | 215839 ANDA215839 |
| Docosanol | DOCOSANOL | Alembic Pharmaceuticals Inc. | 86450000-1810-4739-9801-59beb7c19e67 | 2023-12-22 | Warnings | 215839 ANDA215839 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71589-019-03 | 71589001903 | 1 BOTTLE, PUMP in 1 PACKAGE (71589-019-03) > 2 g in 1 BOTTLE, PUMP | 2022-05-03 | 0000-00-00 | No | No | Current |