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 |
|---|---|---|---|---|---|---|
| Dandruff | PYRITHIONE ZINC | Better Living Brands, LLC | 03799050-cb2e-4c96-b177-55e6fc145d6b | 2026-02-23 | Warnings, Adverse reactions | M032 |
| Everyday Clean | PYRITHIONE ZINC | Perrigo Direct, Inc | c36e18cf-eec0-4972-b3b5-fe3865a438d8 | 2026-02-19 | Warnings, Adverse reactions | M032 |
| Everyday Clean Dandruff | PYRITHIONE ZINC | Meijer, Inc. | 34b80460-fcb9-42a8-b120-1558dc5093fa | 2026-02-19 | Warnings, Adverse reactions | M032 |
| Dandruff | PYRITHIONE ZINC 1% | Meijer, Inc. | 28525947-97f6-4b3f-b8bd-596ffcf61188 | 2026-02-19 | Warnings, Adverse reactions | M032 |
| Dry Scalp | PYRITHIONS ZINC | Meijer, Inc. | 57a944af-397f-41d9-bfe0-7cac0dd26cb1 | 2026-02-19 | Warnings, Adverse reactions | M032 |
| Everyday Clean | PYRITHIONE ZINC | Meijer, Inc. | 9ca4dd70-3dca-4d5a-a13d-51a5dbf92af0 | 2026-02-19 | Warnings, Adverse reactions | M032 |
| Head and Shoulders Hydrating Coconut Kit | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | 4b33d7cd-93ae-6ec9-e063-6294a90afc63 | 2026-02-19 | Warnings | M032 |
| Dandruff | SELENIUM SULFIDE | Meijer, Inc. | c0e4f8cb-74fc-4c0d-9721-f87aa2aa1992 | 2026-02-19 | Warnings, Adverse reactions | M032 |
| Selsun Blue Naturals Itchy, Dry Scalp | SALICYLIC ACID | Chattem, Inc. | ed031a0f-7467-4b2c-a6b6-95306f6ee828 | 2026-02-18 | Warnings | M032 |
| Head and Shoulders Hydrating Coconut 2in1 | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | 4b1a4f24-ff9b-9677-e063-6294a90a9c22 | 2026-02-18 | Warnings | M032 |
| Head and Shoulders Coconut 2in1 | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | 7cc1c6c8-27cd-6d9e-e053-2991aa0a99df | 2026-02-18 | Warnings | M032 |
| Head and Shoulders Tea Tree Oil 2in1 | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | 96b37f23-230f-0652-e053-2a95a90a1f64 | 2026-02-18 | Warnings | M032 |
| Head and Shoulders Bare Minimal Ingredients Sensitive Scalp Care | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | 38921198-56d3-ab01-e063-6394a90a89b9 | 2026-02-18 | Warnings | M032 |
| Head and Shoulders Smooth and Silky 2in1 | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | 6d1de62a-b1ab-4ae1-8b8d-e9f0b85beb59 | 2026-02-18 | Warnings | M032 |
| Head and Shoulders Hydrating Coconut | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | 4b20caa0-9ec6-3bfc-e063-6294a90ac68e | 2026-02-18 | Warnings | M032 |
| Selsun Blue 2-in-1 | SELENIUM SULFIDE | Chattem, Inc. | f97e458c-cce3-498f-81fc-1b96a4e8f50a | 2026-02-18 | Warnings | M032 |
| Selsun Blue Itchy Dry Scalp | PYRITHIONE ZINC | Chattem, Inc. | c491014d-f8c7-46bb-b065-eaf5ea842860 | 2026-02-18 | Warnings | M032 |
| Dandruff | PYRITHIONE ZINC | United Natural Foods, Inc. dba UNFI | 77b2e0da-a6d7-42b5-92af-4e7979817b78 | 2026-02-17 | Warnings, Adverse reactions | M032 |
| Dry Scalp Care | PYRITHIONE ZINC | United Natural Foods, Inc. dba UNFI | 064ff929-d965-4b1a-98a9-f2779f346d7f | 2026-02-17 | Warnings, Adverse reactions | M032 |
| Dandruff | PYRITHIONE ZINC | United Natural Foods, Inc. dba UNFI | d7c4507e-7f74-4bcd-9b0e-0b097193a1a8 | 2026-02-17 | Warnings, Adverse reactions | 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 |