dandRX 1% Ketoconazole Anti-Dandruff
- Product NDC
- 85521-001
- 11-digit product format
- 855210001
- Labeler code
- 85521
- Product ID
- 85521-001_324fb7bb-4b8f-e6e6-e063-6394a90adae1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- dandRX 1% Ketoconazole Anti-Dandruff Shampoo
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- dandRX LLC
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-04-09
- Substance
- KETOCONAZOLE
- Active strength
- 1 g/100mL
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 | 85521-001 | D | Discontinued by firm | 2026-09-09 | ||
| excluded package | package | 85521-001 | 85521-001-01 | D | Discontinued by firm | 2026-09-09 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5 | Product name | 2 | 20250331 |
| 1e18fb2e-aeff-8efe-93be-5a5f7be8faa2 | Product name | 2 | 20211209 |
| 8bc3781f-20ed-678b-44a7-a981e693c65f | Product name | 2 | 20211209 |
| ff3a8c91-648c-300b-467e-10703f514265 | Product name | 2 | 20180809 |
| 152a96a4-36b6-f5b1-d4e6-9a500e06bbf3 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85521-001-01 | dandRX 1% Ketoconazole Anti-Dandruff | 236 mL in 1 BOTTLE | LIQUID | 236 | 1 |
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 |
|---|---|---|---|---|---|---|
| Hair Regrowth Foam | GLYCERIN | Shantou Ouhoe Technology Co., Ltd. | 59ef5953-e96f-5707-e063-6294a90a3094 | 2026-08-26 | Warnings | M016 |
| Acne Relief | SALICYLIC ACID,NIACINAMIDE,PANTHENOL. | Guangzhou Senmai Biotechnology Co.,Ltd. | 59db0143-de57-59d2-e063-6294a90a32a8 | 2026-08-25 | Warnings | M016 |
| Witch Hazel | WITCH HAZEL | Your Military Exchanges | 4079fd56-55f3-4e69-93e0-7590c07fb794 | 2026-08-25 | Warnings, Adverse reactions | M016 |
| Salicylic Acid Acne Gel Cleanser | SALICYLIC ACID,PANTHENOL | Guangzhou Senmai Biotechnology Co.,Ltd. | 59eb395b-493b-efc9-e063-6294a90aa891 | 2026-08-25 | Warnings | M016 |
| Claravie | DIMETHICONE | Gentell LLC | 59c6da39-b5f1-8253-e063-6394a90a0e8f | 2026-08-24 | Warnings | M016 |
| MUSTELA Diaper Rash 1 2 3 | ZINC OXIDE | Expanscience Laboratories d/b/a Mustela | 59cf1d1e-e951-9d58-e063-6394a90af0f3 | 2026-08-24 | Warnings | M016 |
| Claravie | ZINC OXIDE, DIMETHICONE | Gentell LLC | 598a5c0b-1e2f-1335-e063-6394a90ac4f4 | 2026-08-21 | Warnings | M016 |
| MUSTELA Diaper Rash 1 2 3 | ZINC OXIDE | Expanscience Laboratories d/b/a Mustela | 163f388e-849d-4b7e-93c1-9045d77a9ec2 | 2026-08-21 | Warnings | M016 |
| Medline | WHITE PETROLATUM, ZINC OXIDE | Medline Industries, LP | 0073de92-585d-e01a-e063-6394a90a2ec2 | 2026-08-21 | Warnings | M016 |
| Mederma PM | DIMETHICONE | L Perrigo Company | 8c728904-28f4-4333-a9ea-20996fd1b007 | 2026-08-21 | Warnings | M016 |
| Earths Care Hemorrhoid Relief | WITCH HAZEL AND MENTHOL, UNSPECIFIED FORM | DLC Laboratories, Inc. | e860d65b-126d-4d77-8003-9d1381849ab5 | 2026-08-20 | Warnings | M016 |
| ClaraVie | PETROLATUM | Gentell LLC | 596987e4-4205-b911-e063-6294a90aa570 | 2026-08-19 | Warnings | M016 |
| ClaraVie | ZINC OXIDE | Gentell LLC | 596abd98-17d7-2a22-e063-6294a90af57d | 2026-08-19 | Warnings | M016 |
| Claravie Skin Repair Cream | DIMETHICONE | Gentell LLC | 596ae269-172e-aef5-e063-6394a90a4e2a | 2026-08-19 | Warnings | M016 |
| Claravie | LANOLIN | Gentell LLC | 596c1b73-e34d-c97d-e063-6394a90ada1b | 2026-08-19 | Warnings | M016 |
| ClaraVie | MENTHOL, ZINC OXIDE | Gentell LLC | 596c467f-a056-ea78-e063-6394a90a79f2 | 2026-08-19 | Warnings | M016 |
| ClaraVie | LANOLIN | Gentell LLC | 596fe32d-be34-0635-e063-6394a90a2fc0 | 2026-08-19 | Warnings | M016 |
| Medpride | ZINC OXIDE | Shield Line LLC | e2689cae-e347-4c0b-825b-6281a0b7c2f1 | 2026-08-18 | Warnings | M016 |
| Eczema Skin Relief Cream | COLLOIDAL OATMEAL | CVS Health | 98fac854-f7b0-4c6e-888d-1bdc6b9323b9 | 2026-08-17 | Warnings | M016 |
| Zinc Oxide | ZINC OXIDE | ADUSA Distribution, LLC | 5940399c-31e3-6d51-e063-6294a90a8e7c | 2026-08-17 | Warnings, Adverse reactions | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 240812 | ketoconazole 1 % Medicated Shampoo | PSN | 324fb7bb-4b8e-e6e6-e063-6394a90adae1 | 1 |
| 240812 | ketoconazole 10 MG/ML Medicated Shampoo | SCD | 324fb7bb-4b8e-e6e6-e063-6394a90adae1 | 1 |
| 240812 | ketoconazole 1 % Medicated Shampoo | SY | 324fb7bb-4b8e-e6e6-e063-6394a90adae1 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85521-001-01 | 85521000101 | 236 mL in 1 BOTTLE (85521-001-01) | 236 ml | 2025-04-09 | No | No | Historical |