clindamycin phosphate
- Product NDC
- 59762-3728
- Requested package NDC
- 59762-3728-2
- 11-digit product format
- 597623728
- Labeler code
- 59762
- Product ID
- 59762-3728_58115c66-1890-4a4b-bc1d-643465edc6a3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clindamycin phosphate
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Greenstone LLC
- Application
- NDA050537
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 1980-06-20
- Marketing end
- 0000-00-00
- Substance
- CLINDAMYCIN PHOSPHATE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 | 59762-3728 | 59762-3728-2 | D | Discontinued by firm | 2026-10-05 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050537-001 | CLEOCIN T | CLINDAMYCIN PHOSPHATE | EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD, Approved before 1982 | ||
| N050537-002 | CLEOCIN | CLINDAMYCIN PHOSPHATE | EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SWAB / TOPICAL | RLD | 1994-02-22 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N050537-001 | CLEOCIN T | EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N050537-002 | CLEOCIN | EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SWAB / TOPICAL | RLD | 1994-02-22 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N050537-001 | CLEOCIN T | EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050537-002 | CLEOCIN | EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SWAB / TOPICAL | RLD | 1994-02-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050537-001 | CLEOCIN T | EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050537-002 | CLEOCIN | EQ 1% BASE | SWAB / TOPICAL | RLD | 1994-02-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050537-001 | CLEOCIN T | EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050537-002 | CLEOCIN | EQ 1% BASE | SWAB / TOPICAL | RLD | 1994-02-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050537-001 | CLEOCIN T | EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050537-002 | CLEOCIN | EQ 1% BASE | SWAB / TOPICAL | RLD | 1994-02-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050537-001 | CLEOCIN T | EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050537-002 | CLEOCIN | EQ 1% BASE | SWAB / TOPICAL | RLD | 1994-02-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050537-001 | CLEOCIN T | EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050537-002 | CLEOCIN | EQ 1% BASE | SWAB / TOPICAL | RLD | 1994-02-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050537-001 | CLEOCIN T | EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050537-002 | CLEOCIN | EQ 1% BASE | SWAB / TOPICAL | RLD | 1994-02-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050537-001 | CLEOCIN T | EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050537-002 | CLEOCIN | EQ 1% BASE | SWAB / TOPICAL | RLD | 1994-02-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050537-001 | CLEOCIN T | EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050537-002 | CLEOCIN | EQ 1% BASE | SWAB / TOPICAL | RLD | 1994-02-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050537-001 | CLEOCIN T | EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050537-002 | CLEOCIN | EQ 1% BASE | SWAB / TOPICAL | RLD | 1994-02-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050537-001 | CLEOCIN T | EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N050537-002 | CLEOCIN | EQ 1% BASE | SWAB / TOPICAL | RLD | 1994-02-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050537-001 | CLEOCIN T | EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050537-002 | CLEOCIN | EQ 1% BASE | SWAB / TOPICAL | RLD | 1994-02-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050537-001 | CLEOCIN T | EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050537-002 | CLEOCIN | EQ 1% BASE | SWAB / TOPICAL | RLD | 1994-02-22 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050537-001 | CLEOCIN T | EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050537-002 | CLEOCIN | EQ 1% BASE | SWAB / TOPICAL | RLD | 1994-02-22 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N050537-001 | CLEOCIN T | EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N050537-002 | CLEOCIN | EQ 1% BASE | SWAB / TOPICAL | RLD | 1994-02-22 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050537-001 | CLEOCIN T | EQ 1% BASE | SOLUTION / TOPICAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050537-002 | CLEOCIN | EQ 1% BASE | SWAB / TOPICAL | RLD | 1994-02-22 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N050537-001 | CLEOCIN T | EQ 1% BASE | SOLUTION / TOPICAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N050537-002 | CLEOCIN | EQ 1% BASE | SWAB / TOPICAL | RLD | 1994-02-22 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N050537-001 | CLEOCIN T | EQ 1% BASE | SOLUTION / TOPICAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N050537-002 | CLEOCIN | EQ 1% BASE | SWAB / TOPICAL | RLD | 1994-02-22 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N050537-001 | CLEOCIN T | EQ 1% BASE | SOLUTION / TOPICAL | AT | RLD, RS, Approved before 1982 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N050537-002 | CLEOCIN | EQ 1% BASE | SWAB / TOPICAL | AT | RLD | 1994-02-22 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N050537-001 | AT | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N050537-002 | AT | 1 | 74a2ff9319b5… |
| 2021-03-12 10:30 UTC | 2021-03 | N050537-002 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N050537-001 | AT | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N050537-002 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N050537-001 | AT | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N050537-002 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N050537-001 | AT | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N050537-002 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N050537-001 | AT | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N050537-002 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N050537-001 | AT | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N050537-002 | AT | 1 | ea99ee380514… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59762-3728-1 | clindamycin phosphate | 1 in 1 CARTON | SOLUTION | 1 | 25 | |
| 59762-3728-1 | clindamycin phosphate | 30 mL in 1 BOTTLE | SOLUTION | 30 | 25 | |
| 59762-3728-2 | clindamycin phosphate | 60 mL in 1 BOTTLE | SOLUTION | 60 | 25 | |
| 59762-3728-2 | clindamycin phosphate | 1 in 1 CARTON | SOLUTION | 1 | 25 | |
| 59762-3728-3 | clindamycin phosphate | 60 in 1 CARTON | SOLUTION | 60 | 25 | |
| 59762-3728-3 | clindamycin phosphate | 1 mL in 1 PACKET | SOLUTION | 1 | 25 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59762-3728-1 | ML - Milliliter | 59762-3728 | 75fd9d84-e08d-42f8-84f7-49b3bc4a10cf | 1 | 2012-07-24 |
| 59762-3728-2 | ML - Milliliter | 59762-3728 | b4fc8cc6-186c-4c9e-87d3-fa7aa3fea670 | 1 | 2012-07-24 |
| 59762-3728-3 | EA - Each | 59762-3728 | 3c51efab-1564-45a0-a0a7-dd11f30f0756 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 59762-3728 | CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE GEL [MYLAN PHARMACEUTICALS INC.] | 24 | Legacy NDC, 6 package rows | 20250529_f7480256-8b32-419a-8983-e2c413040dba.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| clindamycin phosphate | CLINDAMYCIN PHOSPHATE | Mylan Pharmaceuticals Inc. | f7480256-8b32-419a-8983-e2c413040dba | 2025-12-12 | Warnings, Adverse reactions | 59762-3728-2 59762-3728 59762372802 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197519 | clindamycin phosphate 1 % Topical Lotion | PSN | f7480256-8b32-419a-8983-e2c413040dba | 25 |
| 309333 | clindamycin phosphate 1 % Topical Solution | PSN | f7480256-8b32-419a-8983-e2c413040dba | 25 |
| 2676585 | clindamycin phosphate 1 % Twice-Daily Topical Gel | PSN | f7480256-8b32-419a-8983-e2c413040dba | 25 |
| 197519 | clindamycin 10 MG/ML Topical Lotion | SCD | f7480256-8b32-419a-8983-e2c413040dba | 25 |
| 309333 | clindamycin 10 MG/ML Topical Solution | SCD | f7480256-8b32-419a-8983-e2c413040dba | 25 |
| 2676585 | Twice-Daily clindamycin 0.01 MG/MG Topical Gel | SCD | f7480256-8b32-419a-8983-e2c413040dba | 25 |
| 197519 | clindamycin (as clindamycin phosphate) 1 % Topical Lotion | SY | f7480256-8b32-419a-8983-e2c413040dba | 25 |
| 309333 | clindamycin (as clindamycin phosphate) 1 % Topical Solution | SY | f7480256-8b32-419a-8983-e2c413040dba | 25 |
| 2676585 | clindamycin (as clindamycin phosphate) 1 % Twice-Daily Topical Gel | SY | f7480256-8b32-419a-8983-e2c413040dba | 25 |
| 197519 | clindamycin 1 % Topical Lotion | SY | f7480256-8b32-419a-8983-e2c413040dba | 25 |
| 309333 | clindamycin 1 % Topical Solution | SY | f7480256-8b32-419a-8983-e2c413040dba | 25 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 59762-3728-2 | 59762372802 | 1 BOTTLE in 1 CARTON (59762-3728-2) > 60 mL in 1 BOTTLE | 1 bottle | 1980-06-20 | 0000-00-00 | No | No | Current |