Thera-Gel
- Product NDC
- 0904-5259
- 11-digit product format
- 009045259
- Labeler code
- 0904
- Product ID
- 0904-5259_0ee62461-8b30-435e-8069-8947df75f89a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Coal Tar
- Dosage form
- SHAMPOO
- Route
- TOPICAL
- Labeler
- Major Pharmaceuticals
- Application
- M032
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2010-05-18
- Substance
- COAL TAR
- Active strength
- 5 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Thera-Gel
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| COAL TAR | 5 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| R533ESO2EC | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 309381 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1c18fde9-d39b-4339-8f62-3f352d450291 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0904-5259-44 | Thera-Gel | 251 mL in 1 BOTTLE, PLASTIC | SHAMPOO | 251 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-5259-44 | ML - Milliliter | 0904-5259 | d98cc74c-1c8d-4a0f-80f8-ffaf22ce5e7e | 1 | 2013-02-13 |
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 |
|---|---|---|---|---|---|---|
| Recuren Plus Balanced Scalp | SALICYLIC ACID | REGENEREN PLUS LTD | 50c27b0f-9bf5-de9c-e063-6394a90af41a | 2026-05-04 | Warnings | M032 |
| Mielle Lavender and Lychee Scalp Moisturizing | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | 510212e9-1d12-3a0a-e063-6294a90a1d78 | 2026-05-04 | Warnings | M032 |
| Mielle Lavender and Lychee Scalp Soothing Daily Refresher | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | 51033795-843b-844a-e063-6394a90ad091 | 2026-05-04 | Warnings | M032 |
| Mielle Lavender and Lychee Scalp Soothing Conditioner | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | 5103ddfe-c5a1-3c4d-e063-6294a90aa462 | 2026-05-04 | Warnings | M032 |
| Walgreens | SALICYLIC ACID | Walgreens | ec19b9b8-b97f-5277-e053-2a95a90a3c1e | 2026-05-03 | Warnings | M032 |
| Pyrithione Zinc | CVS | Apollo Health and Beauty Care | 34047084-0b26-2385-e063-6394a90a204e | 2026-05-03 | Warnings | M032 |
| CVS Itchy Scalp | PYRITHIONE ZINC | Apollo Health and Beauty Care | 372b25d8-10b0-a049-e063-6394a90a4f61 | 2026-05-03 | Warnings | M032 |
| CVS ANTI DANDRUFF | PYRITHIONE ZINC | Apollo Health and Beauty Care | 3415172f-5a31-1085-e063-6394a90aabdc | 2026-05-03 | Warnings | M032 |
| ProBliva Folliculitis .shampoo. | SELENIUMDISULFIDE 1% | CAVTECH HOLDING LLC | 502caa29-f817-cc12-e063-6394a90a2240 | 2026-04-23 | Warnings | M032 |
| Dermoia Dandruff | PYRITHIONE ZINC | Treasurewise LLC | 7884bd3e-62ab-4fcd-8870-0a941c3feadb | 2026-04-22 | Warnings | M032 |
| BYNISEP 5% MINOXIDIL HAIR GROWTH SERUM | HAIR GROWTH SERUM | Putian Licheng District Zhijiancheng Trading Co., Ltd. | 409de2af-f6f6-8181-e063-6294a90a0b4b | 2026-04-22 | Warnings | M032 |
| Everyday Clean | PYRITHIONE ZINC | Amazon.com Services LLC | 6a634331-eb08-4f18-8a57-692d08918082 | 2026-04-21 | Warnings, Adverse reactions | M032 |
| 2 in 1 Dandruff | PYRITHIONE ZINC | Better Living Brands, LLC | eb1e3236-5981-46c3-ae06-bed61f02a328 | 2026-04-21 | Warnings, Adverse reactions | M032 |
| Everyday Clean Dandruff | PYRITHIONE ZINC | Target Corporation | cc3df9d0-0c16-4176-99d7-d0aec2366f2c | 2026-04-21 | Warnings, Adverse reactions | M032 |
| 2 in 1 Dandruff | PYRITHIONE ZINC | Target Corporation | a9d92e08-a77f-45dd-b95a-9923202df40b | 2026-04-21 | Warnings, Adverse reactions | M032 |
| Dove | PYRITHIONE ZINC | Conopco, Inc. d/b/a/ Unilever | 7885a86b-f1a4-f2cc-e053-2991aa0ab677 | 2026-04-20 | Warnings | M032 |
| Balancing | ZINC PYRITHIONE | Zero Flakes Given, Inc. | 984780fd-4969-150b-e053-2995a90aed77 | 2026-04-16 | Warnings | M032 |
| Restoring | PYRITHIONE ZINC | Zero Flakes Given, Inc. | 4f9934e4-ec37-9f68-e063-6394a90ab9a4 | 2026-04-16 | Warnings | M032 |
| Balancing | PYRITHIONE ZINC | Zero Flakes Given, Inc. | 4f9a51ba-aea6-081f-e063-6394a90a4122 | 2026-04-16 | Warnings | M032 |
| Dove Men Care | ANTI-DANDRUFF GENTLE CLEAN 2 IN 1 SHAMPOO AND CONDITIONER | Conopco d/b/a Unilever | 4ef4b64f-e75d-a2ae-e063-6394a90abd80 | 2026-04-08 | Warnings | M032 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 309381 | coal tar 0.5 % Medicated Shampoo | PSN | 1c18fde9-d39b-4339-8f62-3f352d450291 | 7 |
| 309381 | coal tar 5 MG/ML Medicated Shampoo | SCD | 1c18fde9-d39b-4339-8f62-3f352d450291 | 7 |
| 309381 | coal tar 0.5 % Medicated Shampoo | SY | 1c18fde9-d39b-4339-8f62-3f352d450291 | 7 |
| 309381 | crude coal tar 0.5 % (coal tar solution 2.5 % ) Medicated Shampoo | SY | 1c18fde9-d39b-4339-8f62-3f352d450291 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0904-5259-44 | 00904525944 | 251 mL in 1 BOTTLE, PLASTIC (0904-5259-44) | 251 ml | 2010-05-18 | 0000-00-00 | No | No | Current |