Hermon Balanitis relief kit
- Product NDC
- 85398-014
- 11-digit product format
- 853980014
- Labeler code
- 85398
- Product ID
- 85398-014_3dce086e-a4ec-4b21-e063-6394a90aa1b2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Sulfur 1X HPUS
- Dosage form
- KIT
- Route
- TOPICAL
- Labeler
- Beautivity LLC
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-09-17
- 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
- Hermon Balanitis relief kit
- Listing expiration
- 2026-12-31
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 251267 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3dce086e-a4eb-4b21-e063-6394a90aa1b2 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b64d2752-34ef-378a-1f4f-8bff32b0d1ae | Product name | 4 | 20250626 |
| cb7783e0-feaa-7e56-fb3b-d43b6efa77c9 | Product name | 2 | 20250121 |
| f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6 | Product name | 2 | 20151106 |
| f5395dd2-4395-d8c6-3477-8c2d4a2f951c | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85398-011-01 | Hermon Balanitis relief kit | 116 g in 1 CARTON | SOAP | 1 g in 116 | 1.16 g in 116g | 1 |
| 85398-013-01 | Hermon Balanitis relief kit | 58 g in 1 BOTTLE | CREAM | 58 g | 1 [hp_X] in 58g | 1 |
| 85398-014-01 | Hermon Balanitis relief kit | 1 in 1 CARTON | KIT | 1 | 1 |
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 |
|---|---|---|---|---|---|---|
| Clotrimazole | DRS. CLOTRIMAZOLE | OL PHARMA TECH,LLC | b0e9fc77-6d5c-2472-e053-2995a90a3de4 | 2025-01-09 | Warnings | M005 |
| Anti-Bacterial Wipes | BENZALKONIUM CHLORIDE | Tongling Jieya Biological Technology Co., Ltd. | d7aeb18f-abf2-49bd-a8a3-ac57f60fbe7d | 2025-01-04 | Warnings | M005 |
| AVON HeXashield Athletes Foot Cream | TOLNAFTATE | Tai Guk Pharm. Co., Ltd. | 8f2b6a09-8cb0-0d17-e053-2995a90aa07f | 2025-01-01 | Warnings | M005 |
| Tolnaftate | TOLNAFTATE 1% | Trifecta Pharmaceuticals USA, LLC | 091b907f-544a-86c9-e063-6294a90a5d87 | 2024-12-31 | Warnings | M005 |
| terrasil Fungal Treatment | CLOTRIMAZOLE | Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions | 278290f9-be14-81a8-e063-6294a90ad8cc | 2024-12-26 | Warnings | M005 |
| DEO PEDICO ABOVE NEYMAR JR MEN | DEO PEDICO ABOVE NEYMAR JR MEN | BASTON INDUSTRIA DE AEROSSOIS LTDA | ed4a9844-f20b-da5d-e053-2995a90adc09 | 2024-12-26 | Warnings | M005 |
| Vite20 | MICONAZOLE NITRATE | Blaine Labs Inc. | 28a8d0dd-aab9-44ff-bab6-7ec4b5036a71 | 2024-12-24 | Warnings | M005 |
| Vite20 | UNDECYLENIC ACID | Blaine Labs Inc. | 18f8ea1c-360e-43c0-98df-5816af4dec66 | 2024-12-24 | Warnings | M005 |
| Tolnaftate Cream 1% ANTIFUNGAL | FAMILY WELLNESS TOLNAFTATE | Trifecta Pharmaceuticals USA, LLC | 915759af-0d7f-6a87-e053-2a95a90acbd6 | 2024-12-20 | Warnings | M005 |
| Rugby Clotrimazole Antifungal Cream | CLOTRIMAZOLE | Rugby Laboratories | a1365bc7-b376-adca-e053-2a95a90acf19 | 2024-12-20 | Warnings | M005 |
| Miconazole Nitrate | ANTIFUNGAL MICONAZOLE POWDER SPRAY | Premier Brands of America Inc. | dc7a23bb-b246-89b1-e053-2995a90a9f2d | 2024-12-20 | Warnings | M005 |
| Warrior Antifungal Foot | MICONAZOLE NITRATE 2% | Derma Care Research Labs, LLC | cf2e9dc1-275b-4454-e053-2995a90af295 | 2024-12-20 | Warnings | M005 |
| Tolnaftate Cream 1% | TOLNAFTATE | Pharmacy Value Alliance, LLC. | 3abfd734-229b-1a0e-e054-00144ff88e88 | 2024-12-20 | Warnings | M005 |
| Dermatool Fungal Nail Treatment | TOLNAFTATE 1% | Derma Care Research Labs, LLC | fbc1a55e-b994-4962-e053-6394a90a13ba | 2024-12-19 | Warnings | M005 |
| Novonail Solution | TOLNAFTATE 1% | Derma Care Research Labs, LLC | 013d6107-e3b0-0264-e063-6394a90ae1e2 | 2024-12-19 | Warnings | M005 |
| MICONAZOLE Nitrate 2% Cream ANTIFUNGAL | MICONAZOLE NITRATE | Rugby | f420de00-408f-9a2c-e053-2995a90adced | 2024-12-17 | Warnings | M005 |
| Relispray Antifungal Liquid | TOLNAFTATE | Midas-Care Pharmaceuticals Pvt. Ltd. | 6522ad59-f810-408c-a9f9-9359d79302ce | 2024-12-17 | Warnings | M005 |
| Clotrimazole | FAMILY WELLNESS CLOTRIMAZOLE | Trifecta Pharmaceuticals USA LLC | 915759af-0d7b-6a87-e053-2a95a90acbd6 | 2024-12-13 | Warnings | M005 |
| Blistex Odor-Eaters Powder | TOLNAFTATE | Blistex Inc | 819edb2f-dda7-45c3-b0da-ebcae354154e | 2024-12-12 | Warnings | M005 |
| Walgreens Athletes Foot | TOLNAFTATE SPRAY | Walgreens | c68ad65d-b016-0069-e053-2995a90ae7ef | 2024-12-11 | Warnings | M005 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 251267 | clotrimazole 1 % Medicated Bar Soap | PSN | 3dce086e-a4eb-4b21-e063-6394a90aa1b2 | 1 |
| 251267 | clotrimazole 0.01 MG/MG Medicated Bar Soap | SCD | 3dce086e-a4eb-4b21-e063-6394a90aa1b2 | 1 |
| 251267 | clotrimazole 1 % Medicated Bar Soap | SY | 3dce086e-a4eb-4b21-e063-6394a90aa1b2 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85398-011-01 | 85398001101 | 116 g in 1 CARTON | 116 g | Historical | |||
| 85398-013-01 | 85398001301 | 58 g in 1 BOTTLE | 58 g | Historical | |||
| 85398-014-01 | 85398001401 | 1 KIT in 1 CARTON (85398-014-01) * 116 g in 1 CARTON (85398-011-01) * 58 g in 1 BOTTLE (85398-013-01) | 1 kit | 2025-09-17 | No | No | Current |