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 |
|---|---|---|---|---|---|---|
| 2 in 1 Dandruff | PYRITHIONE ZINC | United Natural Foods, Inc. dba UNFI | ecc20b71-eb6b-43ed-86bc-32d61641ee3a | 2026-02-17 | Warnings, Adverse reactions | M032 |
| Dandruff | PYRITHIONE ZINC | TKC Holdings, Inc. | c3bc9a89-b1f3-4b7a-bebb-00c341956d60 | 2026-02-17 | Warnings, Adverse reactions | M032 |
| Everyday Clean Dandruff | PYRITHIONE ZINC | Valu Merchandisers Company | bb0a74e0-2312-4444-b7e1-19a9a3a7007e | 2026-02-16 | Warnings, Adverse reactions | M032 |
| Dry Scalp | PYRITHIONE ZINC | Valu Merchandisers Company | 6349fd91-675b-4489-8b57-e584f718ca3f | 2026-02-16 | Warnings, Adverse reactions | M032 |
| Dry Scalp Care | PYRITHIONE ZINC | Valu Merchandisers Company | e9fc676c-0313-430f-a422-6dba51241bd5 | 2026-02-16 | Warnings, Adverse reactions | M032 |
| Dandruff | PYRITHIONE ZINC | Valu Merchandisers Company | d5dd333d-fea5-4e03-bd9f-cbc28ea48a80 | 2026-02-16 | Warnings, Adverse reactions | M032 |
| Dandruff | PYRITHIONE ZINC | United Natural Foods, Inc. dba UNFI | 66f301bf-8e2e-43ce-b6b8-0983fe795f01 | 2026-02-16 | Warnings, Adverse reactions | M032 |
| Tuymec Anti-Dandruff Shampoo. | ANTI-DANDRUFF SHAMPOO. | Guangzhou Jingliang Cosmetics Co., Ltd. | 4ae93408-5c8f-c0a5-e063-6394a90a9e0d | 2026-02-15 | Warnings | M032 |
| RoyceDerm Seborrheic Dermatitis and Psoriasis Treatment cream | SALICYLIC ACID 3% | RoyceDerm LLC | 4ac42528-9210-6936-e063-6294a90a4168 | 2026-02-14 | Warnings | M032 |
| OLIVITA 5% Minoxidil | 5% MINOXIDIL | Shenzhen Xinxin Yunhai Technology Co., Ltd. | 4acbdf3d-976a-2cba-e063-6294a90a35e6 | 2026-02-14 | Warnings | M032 |
| VENANOCI Minoxidil | MINOXIDIL | Shenzhen Xinxin Yunhai Technology Co., Ltd. | 4acc38aa-13da-981b-e063-6294a90aede5 | 2026-02-14 | Warnings | M032 |
| Everyday Clean Dandruff | PYRITHIONE ZINC | Topco Associates LLC | fc568c8f-0d59-4b26-8f72-ea70e4316687 | 2026-02-13 | Warnings, Adverse reactions | M032 |
| Dandruff | PYRITHIONE ZINC | Topco Associates LLC | a0f2c58b-bb17-42a3-bd90-be771f60ef20 | 2026-02-13 | Warnings, Adverse reactions | M032 |
| Dandruff | PYRITHIONE ZINC | Topco Associates LLC | 706b856c-ce89-4860-bc5d-9803deb469e7 | 2026-02-13 | Warnings, Adverse reactions | M032 |
| Dry Scalp Care | PYRITHIONE ZINC | Topco Associates LLC | 3300bfd5-ae84-4bc8-a4cd-05472b498fb7 | 2026-02-13 | Warnings, Adverse reactions | M032 |
| Everyday Clean | PYRITHIONE ZINC | Topco Associates LLC | c0abb41f-9df0-4493-8452-592ec30c7924 | 2026-02-13 | Warnings, Adverse reactions | M032 |
| 2 in 1 Dandruff | PYRITHIONE ZINC | Topco Associates LLC | 7da1e057-a69e-4b89-a309-919d88da3b93 | 2026-02-13 | Warnings, Adverse reactions | M032 |
| Pyrithione zinc | PYRITHIONE ZINC | Topco Associates LLC | 2c1420a8-404f-4fd7-8f07-cd441b390ac2 | 2026-02-13 | Warnings, Adverse reactions | M032 |
| Everyday Clean Dandruff | PYRITHIONE ZINC | WinCo Foods, LLC | 2581c531-c068-4dae-b569-3b1f86dad066 | 2026-02-12 | Warnings, Adverse reactions | M032 |
| Dry Scalp | PYRITHIONE ZINC | WinCo Foods, LLC | 4fca1200-dc6c-4e6e-b09c-2ec8ac0fa411 | 2026-02-12 | 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 |