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 |
|---|---|---|---|---|---|---|
| Head and Shoulders Smooth and Silky Kit | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | 4d38902f-a6ae-620f-e063-6394a90ae932 | 2026-03-17 | Warnings | M032 |
| RoyceDerm Seborrheic Dermatitis and Psoriasis Shampoo. | SALICYLIC ACID 3% | RoyceDerm LLC | 4d2f6e29-5d75-6982-e063-6294a90ada8d | 2026-03-16 | Warnings | M032 |
| Dry Scalp Care | PYRITHIONE ZINC | CVS Pharmacy, Inc. | f286a5fd-7916-49bc-97a1-ad737ac5b14a | 2026-03-13 | Warnings, Adverse reactions | M032 |
| Head and Shoulders Itchy Scalp | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | 54df1acc-4265-494c-879e-c690184d7ae2 | 2026-03-13 | Warnings | M032 |
| 2 in 1 Dandruff | PYRITHIONE ZINC | H E B | a58b9119-2adb-459f-86f4-95df28a430c5 | 2026-03-13 | Warnings, Adverse reactions | M032 |
| Dry Scalp Care | PYRITHIONE ZINC | Better Living Brands, LLC | f90d1fb2-4bd7-4d70-81b4-4541f4e3a3d6 | 2026-03-13 | Warnings, Adverse reactions | M032 |
| Head and Shoulders Smooth and Silky Conditioner | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | 4cec08cb-aba5-41ce-e063-6294a90adfdf | 2026-03-13 | Warnings | M032 |
| OLIVITA Minoxidil | MINOXIDIL | Shenzhen Xinxin Yunhai Technology Co., Ltd. | 4cf37b0b-bbb8-1d9c-e063-6294a90af818 | 2026-03-13 | Warnings | M032 |
| Dandruff | PYRITHIONE ZINC | Nice-Pak Products, LLC | 3c55b70f-7627-8667-e063-6394a90a5cf8 | 2026-03-12 | Warnings, Adverse reactions | M032 |
| Head and Shoulders 2in1 Classic Clean | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | 65a4082f-227b-49bf-b88c-b1c651ed13a0 | 2026-03-12 | Warnings | M032 |
| Head and Shoulders Green Apple 2in1 | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | c036c9a6-6507-4037-b97b-1b015dd950c1 | 2026-03-12 | Warnings | M032 |
| Anti-Fungal | ANTI-FUNGAL SHAMPOO | Shenzhen Mengyue Technology Co., Ltd. | 4ca9a661-fa39-ab7f-e063-6294a90aed14 | 2026-03-10 | Warnings | M032 |
| iBeaLee 5% Minoxidil Hair Regrowth Treatment | 5% MINOXIDIL | Shenzhen Earth Surface Trading Co., Ltd. | 4cb728d0-6abe-6645-e063-6394a90acb4c | 2026-03-10 | Warnings | M032 |
| DHS Tar | COAL TAR | Person and Covey | 4c5f7278-c53a-cef6-e063-6394a90a0008 | 2026-03-09 | Warnings | M032 |
| DHS ZINC | PYRITHIONE ZINC | Person and Covey | 4c98c0af-c3d0-211e-e063-6294a90a8e12 | 2026-03-09 | Warnings | M032 |
| DHS SAL | SALICYLIC ACID | Person and Covey | 4c9b75b5-9c7d-c4a8-e063-6394a90a4a6b | 2026-03-09 | Warnings | M032 |
| DHS BODY WASH | ZINC PYRITHIONE WASH | Person and Covey | 4c9d5b33-9a1e-9db1-e063-6294a90adbae | 2026-03-09 | Warnings | M032 |
| Biotin | BIOTIN | Shenzhen yuehaotong Technology Co.,Ltd | 4c6ec616-a84e-6e1a-e063-6294a90a2aae | 2026-03-07 | Warnings | M032 |
| 2 in 1 Dandruff | PYRITHIONE ZINC | Old East Main Co. | 5368b466-a804-471c-8287-0dd120c0d509 | 2026-03-03 | Warnings, Adverse reactions | M032 |
| Dandruff | PYRITHIONE ZINC | Amazon.com Services LLC | c187bb79-8190-4a3d-a966-af74198ee546 | 2026-03-03 | 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 |