Psoriasin Gel
- Product NDC
- 52389-166
- 11-digit product format
- 523890166
- Labeler code
- 52389
- Product ID
- 52389-166_ebf1fc75-1cd9-92fa-e053-2995a90a98ab
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Coal Tar Topical Gel
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Alva-Amco Pharmacal Companies, Inc.
- Application
- M032
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 1996-02-18
- Marketing end
- 0000-00-00
- Substance
- COAL TAR
- Active strength
- 13 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 product | product | 52389-166 | D | Discontinued by firm | 2026-10-12 | ||
| excluded package | package | 52389-166 | 52389-166-01 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 52389-166 | 52389-166-21 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 52389-166 | 52389-166-42 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 52389-166 | 52389-166-43 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 52389-166 | 52389-166-56 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 52389-166 | 52389-166-57 | D | Discontinued by firm | 2026-10-12 |
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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 52389-166-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 52389-166-21 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 52389-166-42 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 52389-166-43 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 52389-166-56 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 52389-166-42 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 52389-166-21 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 52389-166-42 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 52389-166-21 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 52389-166-42 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 52389-166-21 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 52389-166-42 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 52389-166-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 52389-166-42 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 52389-166-21 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 52389-166-42 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 52389-166-21 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 52389-166-42 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 52389-166-21 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 52389-166-42 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 52389-166-21 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 52389-166-42 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 52389-166-21 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 52389-166-42 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 52389-166-21 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 52389-166-42 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 52389-166-21 | 557ba5c1ecfa… | 9c80585c8c6e… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| DermaZinc | PYRITHIONE ZINC | WynnPharm Inc | e73010ae-291d-6adf-e053-2a95a90a8aea | 2025-11-14 | Warnings | M032 |
| Head and Shoulders 2in1 Men Advanced Series Pure Sport Old Spice | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | 7bbd2559-4aba-9f18-e053-2991aa0a152e | 2025-11-13 | Warnings | M032 |
| Divine Dandrene 1% | ZINC PYRITHIONE | DS Healthcare Group, Inc. | ab605699-4090-45a3-882f-44379fe2a82e | 2025-11-11 | Warnings | M032 |
| Divine Dandrene 2% | ZINC PYRITHIONE | DS Healthcare Group, Inc. | 54b0a610-dd15-4064-9feb-4d30b5e522ad | 2025-11-11 | Warnings | M032 |
| Dandrene Anti-Dandruff Conditioner | ZINC PYRITHIONE | DS Healthcare Group, Inc. | aed49bfe-e016-46ac-a025-81b47cc08147 | 2025-11-11 | Warnings | M032 |
| Minoxidil hair growth serum | MINOXIDIL HAIR GROWTH SERUM | Jiashen International Trade Limited | 26cc22be-30f6-03da-e063-6394a90aafe7 | 2025-11-09 | Warnings | M032 |
| Sulfur 8 Kids Anti-Dandruff | PYRITHIONE ZINC | J. Strickland & Co. | 89f4ecc8-7a49-42cb-b85d-71c9299e6712 | 2025-11-07 | Warnings | M032 |
| Sulfur 8 Aqua Blue | PYRITHIONE ZINC | J. Strickland & Co. | cdcf3cea-4a5d-4b8b-b47d-3163f9837d16 | 2025-11-07 | Warnings | M032 |
| Sulfur 8 Scalp Therapy Medicated Dandruff Control | PYRITHIONE ZINC | J. Strickland and Co. | 96b26da0-d0d7-77ed-e053-2995a90a7a78 | 2025-11-07 | Warnings | M032 |
| Shailee Psoriasis Treatment | SALICYLIC ACID | Foshan Sugar Max Cosmetics CO.,Ltd | 02a71ce4-baf5-4231-afd6-21ef0b22e931 | 2025-11-05 | Warnings | M032 |
| Sulfur 8 Kids Anti-Dandruff Hair and Scalp Conditioner | SULFUR | J. Strickland & Co. | 8e9da3fd-701e-4354-bb00-ecd4dab48fa3 | 2025-11-03 | Warnings | M032 |
| Denorex Severe Flakes Medicated Anti Dandruff | PYRITHIONE ZINC | Neoteric Cosmetics, Inc. | 41ad0d3a-0704-44c9-e063-6394a90ad40d | 2025-10-21 | Warnings | M032 |
| Stay Minoxidil Hair Regrowth Treatment | MINOXIDIL 5% | HALORIA INC. | 41b745d7-6947-ec24-e063-6294a90aa467 | 2025-10-21 | Warnings | M032 |
| DERMOSCRIBE SEBORRHEIC DERMATITIS | SULFUR, SALICYLIC ACID, HYDROCORTISONE | DERMOSCRIBE PTY LTD | 2b6bf90b-5d42-4c08-afee-56e13122285e | 2025-10-17 | Warnings | M032 |
| Shea Moisture | APPLE CIDER VINEGAR INSTANT SCALP REFRESH ANTI-DANDRUFF SPRAY | Conopco, Inc. d/b/a Unilever | 414ab8ec-165c-21f8-e063-6294a90adc4f | 2025-10-16 | Warnings | M032 |
| Shea Moisture | APPLE CIDER VINEGAR ANTI-DANDRUFF LEAVE-IN | Conopco, Inc. d/b/a Unilever | 414b7fd2-6a65-af39-e063-6394a90a00b8 | 2025-10-16 | Warnings | M032 |
| Seacall Natural Cedarwood Oil | NATURAL CEDARWOOD OIL | Guangdong Quadrant Ecological Technology Co., Ltd. | 1f4ebe4d-6e93-378c-e063-6394a90aec95 | 2025-10-15 | Warnings | M032 |
| RemedyDandruffShampooTreatment | ACTIIV REMEDY DANDRUFF SHAMPOO TREATMENT | Naturich Cosmetique Labs | 129fd043-6643-cc46-e063-6294a90a6eae | 2025-10-08 | Warnings | M032 |
| Head and Shoulders Clinical Strength Cooling Itch Relief | SELENIUM SULFIDE | The Procter & Gamble Manufacturing Company | 40464e2d-f738-33ec-e063-6394a90a02c2 | 2025-10-03 | Warnings | M032 |
| Head and Shoulders 2in1 Clinical Strength Cooling Itch Relief | SELENIUM SULFIDE | The Procter & Gamble Manufacturing Company | 4046c345-e1ac-0ecc-e063-6294a90a59fa | 2025-10-03 | Warnings | M032 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 52389-166-01 | 52389016601 | 1 TUBE in 1 CARTON (52389-166-01) > 28.35 g in 1 TUBE (52389-166-28) | 1 tube | 2013-03-15 | 0000-00-00 | No | No | Current |
| 52389-166-43 | 52389016643 | 2 TUBE in 1 BOX (52389-166-43) > 21.25 g in 1 TUBE | 2 tube | 2020-06-01 | 0000-00-00 | No | No | Current |
| 52389-166-56 | 52389016656 | 2 TUBE in 1 CARTON (52389-166-56) > 28.35 g in 1 TUBE (52389-166-28) | 2 tube | 2013-10-01 | 0000-00-00 | No | No | Current |