TopCare
- Product NDC
- 36800-381
- 11-digit product format
- 368000381
- Labeler code
- 36800
- Product ID
- 36800-381_39ac8059-4dd6-6d84-e063-6294a90a8496
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Topco Associates LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2012-03-21
- Substance
- NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
- Active strength
- 3.5; 10000; 10 mg/g; [iU]/g; mg/g
- Pharmacologic classes
- Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
- 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
- TopCare
- Brand name suffix
- Antibiotic Plus Pain Relief
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NEOMYCIN SULFATE | 3.5 mg/g |
| POLYMYXIN B SULFATE | 10000 [iU]/g |
| PRAMOXINE HYDROCHLORIDE | 10 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 057Y626693 | Internal UNII lookup |
| 19371312D4 | Internal UNII lookup |
| 88AYB867L5 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1359360 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 55dc4025-f07f-41b2-8b18-6a11ee04b5cc | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 99e684e6-f435-feb8-d2bb-3a546f1cb768 | Product name | 2 | 20161117 |
| 25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c | Product name | 1 | 20160603 |
| 58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8 | Product name | 1 | 20140508 |
| a7051cba-790b-a699-81f8-dbbbdbd9b5ac | Product name | 1 | 20140508 |
| b045ad64-0f28-9a02-2f9b-b34d94fb2278 | Product name | 1 | 20140508 |
| b6082387-f592-1148-0844-bd068fd213fb | Product name | 1 | 20140508 |
| da108d9e-edc8-17a3-8c28-3251c6a8accc | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-381-01 | TopCareAntibiotic Plus Pain Relief | 1 in 1 CARTON | CREAM | 1 | 4 | |
| 36800-381-01 | TopCareAntibiotic Plus Pain Relief | 14.2 g in 1 TUBE | CREAM | 14.2 | 4 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 36800-381 | TOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241114_55dc4025-f07f-41b2-8b18-6a11ee04b5cc.zip |
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 |
|---|---|---|---|---|---|---|
| Fruit of the Earth Aloe Vera Cool Blue | LIDOCAINE HYDROCHLORIDE | Fruit of the Earth, Inc. | 1d65bc34-2bc2-4f52-a9b3-1cb08324eb79 | 2024-07-19 | Warnings | M017 |
| Ultra Balm | MENTHOL AND METHYL SALICYLATE | Ling Nam Medicine Factory (H.K.) Ltd. | de997baf-aa04-474e-b912-3fc67e720d0b | 2024-07-19 | Warnings | M017 |
| Ling Nam Hak Kwai Oil | TURPENTINE OIL | Ling Nam Medicine Factory (H.K.) Ltd. | 3f16cce3-366f-41f3-8829-6de4082a8c19 | 2024-07-19 | Warnings | M017 |
| Koong Yick Hak Kwai Oil | TURPENTINE OIL | Ling Nam Medicine Factory (H.K.) Ltd. | bc33e185-3b42-98b5-e053-2995a90a6308 | 2024-07-18 | Warnings | M017 |
| Koong Yick Hung Fa | METHYL SALICYLATE | Ling Nam Medicine Factory (H.K.) Ltd. | 9c8a121d-6da2-4435-a2d7-a0b71d10740d | 2024-07-18 | Warnings | M017 |
| Ling Nam Hung Far | METHYL SALICYLATE | Ling Nam Medicine Factory (H.K.) Ltd. | b6916b6e-b7eb-1eb7-e053-2995a90ae6fb | 2024-07-18 | Warnings | M017 |
| itch relief | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Bionpharma Inc. | 178ed513-4f22-8f11-e063-6294a90a109b | 2024-07-16 | Warnings | M017 |
| POWERECT Benzocaine Male Delay Gel | BENZOCAINE | SKINS SEXUAL HEALTH LIMITED | 2fafe1f2-a31e-4b2a-bc51-81e16b319c3a | 2024-07-16 | Warnings | M017 |
| SKINS DELAY Climax Control Benzocaine Gel | BENZOCAINE | SKINS SEXUAL HEALTH LIMITED | 53730576-2609-4f28-8bfa-a1ceea698b83 | 2024-07-16 | Warnings | M017 |
| TIDL PAIN RELIEF CRYO THERAPY Unscented formula Spray. | PAIN RELIEF CRYO THERAPY UNSCENTED FORMULA SPRAY | Shenzhen Sam Technology Co., Ltd. | 1d1a0346-3b00-4803-e063-6294a90aec6d | 2024-07-13 | Warnings | M017 |
| Tidl Pain Relief Evening Therapy Spray. | PAIN RELIEF EVENING THERAPY SPRAY | Shenzhen Sam Technology Co., Ltd. | 1d1a2f4a-7b25-e595-e063-6394a90a00d5 | 2024-07-13 | Warnings | M017 |
| TIDL PAIN RELIEF HEAT THERAPY ROLL-ON | PAIN RELIEF HEAT THERAPY ROLL-ON | Shenzhen Sam Technology Co., Ltd. | 1d0b7b8f-9e5d-00f7-e063-6394a90af87c | 2024-07-12 | Warnings | M017 |
| TIDL PAIN RELIEF CRYO THERAPY original formula Spray. | PAIN RELIEF CRYO THERAPY ORIGINAL FORMULA SPRAY | Shenzhen Sam Technology Co., Ltd. | 1d0b94ec-f956-dff2-e063-6294a90aca4a | 2024-07-12 | Warnings | M017 |
| TIDL PAIN RELIEF CRYO THERAPY MAX Strength Spray. | PAIN RELIEF CRYO THERAPY MAX STRENGTH SPRAY | Shenzhen Sam Technology Co., Ltd. | 1d0bf4f9-6b02-6cec-e063-6294a90a36c7 | 2024-07-12 | Warnings | M017 |
| Burn Relief | LIDOCAINE HCI 2.0% | Trifecta Pharmaceuticals USA, LLC. | e5e524cd-bb22-715f-e053-2995a90ab5d3 | 2024-07-12 | Warnings | M017 |
| Ralli Rapid Pain Relief | MENTHOL | Troy Manufacturing, Inc. | 1d10e3ca-dc93-8e1a-e063-6394a90a47c0 | 2024-07-12 | Warnings | M017 |
| TIDL PAIN RELIEF HEAT THERAPY Spray. | PAIN RELIEF HEAT THERAPY SPRAY | Shenzhen Sam Technology Co., Ltd. | 1d199826-1b27-b6e7-e063-6394a90a69ad | 2024-07-12 | Warnings | M017 |
| Tidl Pain Relief Morning Therapy Spray. | PAIN RELIEF MORNING THERAPY SPRAY | Shenzhen Sam Technology Co., Ltd. | 1d19d070-3818-73de-e063-6394a90a8958 | 2024-07-12 | Warnings | M017 |
| Hydrocortisone with aloe | HYDROCORTISONE WITH ALOE ANTI ITCH | NeilMed Pharmaceuticals Inc. | 032b9f58-5f64-04dd-e063-6294a90a6bb9 | 2024-07-10 | Warnings | M017 |
| Octagon Pain Relief | MENTHOL, UNSPECIFIED FORM | NATURAL ESSENTIALS, INC. | 9926f733-1506-4224-9d70-b1813cd81ec3 | 2024-07-08 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1359360 | neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical Cream | PSN | 55dc4025-f07f-41b2-8b18-6a11ee04b5cc | 4 |
| 1359360 | neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical Cream | SCD | 55dc4025-f07f-41b2-8b18-6a11ee04b5cc | 4 |
| 1359360 | neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical Cream | SY | 55dc4025-f07f-41b2-8b18-6a11ee04b5cc | 4 |
| 1359360 | neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical Cream | SY | 55dc4025-f07f-41b2-8b18-6a11ee04b5cc | 4 |
| 1359360 | neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical Cream | SY | 55dc4025-f07f-41b2-8b18-6a11ee04b5cc | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 36800-381-01 | 36800038101 | 1 TUBE in 1 CARTON (36800-381-01) / 14.2 g in 1 TUBE | 1 tube | 2012-03-21 | 0000-00-00 | No | No | Current |