FAK Care4 Bus and School Yellow ORM D
- Product NDC
- 50814-042
- 11-digit product format
- 508140042
- Labeler code
- 50814
- Product ID
- 50814-042_2c4cbe6c-c27a-15fe-e063-6294a90ac409
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOL
- Dosage form
- KIT
- Labeler
- GFA Production (Xiamen) Co., Ltd.
- Application
- M004
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-02-08
- 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
- FAK Care4 Bus and School Yellow ORM D
- Listing expiration
- 2026-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3b5d07c6-bda2-4bc7-89b8-88280d11ed74 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50814-002-01 | FAK Care4 Bus and School Yellow ORM D | 0.45 g in 1 POUCH | SWAB | 0.45 g | 0.13 g in 100g | 7 |
| 50814-002-01 | FAK Care4 Bus and School Yellow ORM D | 1 in 1 BOX | SWAB | 0.13 g in 100g | 7 | |
| 50814-009-01 | FAK Care4 Bus and School Yellow ORM D | 0.9 g in 1 PACKAGE | CREAM | 0.9 g | 1.3 mg in 1g | 7 |
| 50814-039-01 | FAK Care4 Bus and School Yellow ORM D | 1 in 1 BOX | SWAB | 700 mg in 1g | 7 | |
| 50814-039-01 | FAK Care4 Bus and School Yellow ORM D | 0.45 g in 1 BAG | SWAB | 0.45 g | 700 mg in 1g | 7 |
| 50814-041-02 | FAK Care4 Bus and School Yellow ORM D | 0.53 mL in 1 POUCH | SWAB | 0.53 mL | 600 mg in 1mL | 7 |
| 50814-042-01 | FAK Care4 Bus and School Yellow ORM D | 1 in 1 KIT | KIT | 1 | 7 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50814-042 | FAK CARE4 BUS AND SCHOOL YELLOW ORM D (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOL) KIT [GFA PRODUCTION (XIAMEN) CO., LTD.] | 7 | Current NDC, Legacy NDC, 7 package rows | 20250123_3b5d07c6-bda2-4bc7-89b8-88280d11ed74.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 |
|---|---|---|---|---|---|---|
| Triple Antibiotic First Aid Antibiotic | BACITRACIN ZINC, NEOMYCIN AND POLYMYXIN B SULFATE | Universal Distribution Center LLC | 78f00296-267b-44c3-a9e3-c40f122e905e | 2024-05-14 | Warnings | M004 |
| TRIPLE ANTIBIOTIC | BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE | JHK Inc dba American Safety & First Aid | 26e66025-9457-42b3-9319-51302c17506e | 2024-04-26 | Warnings | M004 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | JHK Inc | 1472c854-09c8-4ad8-b8a6-0235440ac26b | 2024-04-26 | Warnings | M004 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | JHK Inc | abae6a80-e859-47b5-8e34-d391eb854583 | 2024-04-26 | Warnings | M004 |
| Antiseptic | BENZALKONIUM CHLORIDE, BENZOCAINE | JHK Inc | 0ac5d890-c262-4a30-9fd8-2de6cb0f7601 | 2024-04-25 | Warnings | M004 |
| First Aid Antibiotic Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | M-star (Hubei) Health&Care Products Co., Ltd. | c6f2656e-b822-4d61-b557-dd2046dd51f5 | 2024-04-01 | Warnings | M004 |
| Antibiotic | BACITRACIN ZINC, POLYMYXIN B SULFATE | CVS PHARMACY, INC | 32e92acf-2e48-4933-8e08-e1df650e7d19 | 2024-03-15 | Warnings | M004 |
| Major Bacitracin | BACITRACIN | Major Pharmaceuticals | 13288efb-e282-68f8-e063-6294a90ae712 | 2024-03-08 | Warnings | M004 |
| UniShield TRIPLE ANTIBIOTIC | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Unishield | 00b85d3a-322b-43c1-b022-5f6ed50c6609 | 2024-03-02 | Warnings | M004 |
| Triple Antibiotic Plus Pain Relief | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Chain Drug Marketing Association Inc. | 1277942d-753f-ab69-e063-6394a90a496a | 2024-02-28 | Warnings | M004 |
| Triple Antibiotic with Pain Relief | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE | Safetec of America, Inc. | ca1df4a0-844d-4b1d-b972-f2704a8ebbab | 2024-02-16 | Warnings | M004 |
| Single Antibiotic | BACITRACIN ZINC | Safetec of America, Inc. | 9993c204-6e61-4da3-90ef-2b7dfa09c920 | 2024-02-14 | Warnings | M004 |
| Single Antibiotic with Neomycin | NEOMYCIN SULFATE | Safetec of America | e989cf7e-f3d1-42d2-af45-fc80095b97cb | 2024-02-08 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Safetec of America, Inc. | 96c41fc1-81f9-4757-abc6-867b5383ed5d | 2024-02-07 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Safetec of America, Inc. | 2c2aa8af-2adb-4f59-ac20-15818d0e28e7 | 2024-02-07 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Safetec of America, Inc. | 03c05028-5a5f-4690-a836-cc1b1044ab39 | 2024-02-05 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Safetec of America, Inc. | 59494d5c-dd8a-431c-8e6a-4e1151ba7460 | 2024-02-05 | Warnings | M004 |
| Triple Antibiotic | FIRST AID ANTIBIOTIC | BluePoint Laboratories | c47e15bd-1062-4cca-e053-2995a90a9075 | 2024-01-31 | Warnings | M004 |
| Neomycin | NEOMYCIN OINTMENT | Dynarex Corporation | 0f9e087b-6e86-a3c7-e063-6394a90ac8d4 | 2024-01-23 | Warnings | M004 |
| Antibiotic and Pain Relief | NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | Target Corporation | 050be94c-1fbb-4d84-82c6-841aac8f318e | 2024-01-18 | Warnings | M004 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 204602 | bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical Ointment | PSN | 3b5d07c6-bda2-4bc7-89b8-88280d11ed74 | 7 |
| 1012100 | benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical Cream | PSN | 3b5d07c6-bda2-4bc7-89b8-88280d11ed74 | 7 |
| 1038558 | benzalkonium chloride 0.13 % Medicated Pad | PSN | 3b5d07c6-bda2-4bc7-89b8-88280d11ed74 | 7 |
| 1046313 | benzocaine 6 % / ethanol 60 % Medicated Pad | PSN | 3b5d07c6-bda2-4bc7-89b8-88280d11ed74 | 7 |
| 797544 | isopropyl alcohol 70 % Medicated Pad | PSN | 3b5d07c6-bda2-4bc7-89b8-88280d11ed74 | 7 |
| 204602 | bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment | SCD | 3b5d07c6-bda2-4bc7-89b8-88280d11ed74 | 7 |
| 1012100 | benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical Cream | SCD | 3b5d07c6-bda2-4bc7-89b8-88280d11ed74 | 7 |
| 1038558 | benzalkonium chloride 1.3 MG/ML Medicated Pad | SCD | 3b5d07c6-bda2-4bc7-89b8-88280d11ed74 | 7 |
| 1046313 | benzocaine 60 MG/ML / ethanol 0.6 ML/ML Medicated Pad | SCD | 3b5d07c6-bda2-4bc7-89b8-88280d11ed74 | 7 |
| 797544 | isopropyl alcohol 0.7 ML/ML Medicated Pad | SCD | 3b5d07c6-bda2-4bc7-89b8-88280d11ed74 | 7 |
| 204602 | bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment | SY | 3b5d07c6-bda2-4bc7-89b8-88280d11ed74 | 7 |
| 1012100 | benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical Cream | SY | 3b5d07c6-bda2-4bc7-89b8-88280d11ed74 | 7 |
| 1038558 | benzalkonium chloride 0.13 % Topical Cloth | SY | 3b5d07c6-bda2-4bc7-89b8-88280d11ed74 | 7 |
| 1038558 | benzalkonium chloride 0.13 % Topical Swab | SY | 3b5d07c6-bda2-4bc7-89b8-88280d11ed74 | 7 |
| 1038558 | benzalkonium chloride 0.13 GM per 100 GM Topical Pad | SY | 3b5d07c6-bda2-4bc7-89b8-88280d11ed74 | 7 |
| 1038558 | benzalkonium chloride 0.13 GM per 100 GM Topical Swab | SY | 3b5d07c6-bda2-4bc7-89b8-88280d11ed74 | 7 |
| 1038558 | benzalkonium chloride 1 ML per 750 ML Topical Swab | SY | 3b5d07c6-bda2-4bc7-89b8-88280d11ed74 | 7 |
| 1046313 | benzocaine 6 % / ethanol 60 % Topical Swab | SY | 3b5d07c6-bda2-4bc7-89b8-88280d11ed74 | 7 |
| 797544 | isopropyl alcohol 70 % Medicated Pad | SY | 3b5d07c6-bda2-4bc7-89b8-88280d11ed74 | 7 |
| 797544 | isopropyl alcohol 70 % Topical Cloth | SY | 3b5d07c6-bda2-4bc7-89b8-88280d11ed74 | 7 |
| 797544 | isopropyl alcohol 70 % Topical Swab | SY | 3b5d07c6-bda2-4bc7-89b8-88280d11ed74 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50814-002-01 | 50814000201 | 0.45 g in 1 POUCH | 0.45 g | Historical | ||||
| 50814-009-01 | 50814000901 | 0.9 g in 1 PACKAGE | 0.9 g | Historical | ||||
| 50814-039-01 | 50814003901 | 1 in 1 BOX | Historical | |||||
| 50814-041-02 | 50814004102 | 0.53 mL in 1 POUCH | 0.53 ml | Historical | ||||
| 50814-042-01 | 50814004201 | 1 KIT in 1 KIT (50814-042-01) * 2 POUCH in 1 KIT / .53 mL in 1 POUCH (50814-041-02) * 2 BAG in 1 KIT / .9 g in 1 BAG (50814-007-01) * 2 PACKAGE in 1 KIT / .9 g in 1 PACKAGE (50814-009-01) * 2 BOX in 1 KIT / 1 POUCH in 1 BOX (50814-002-01) / .45 g in 1 POUCH * 2 BOX in 1 KIT / 1 BAG in 1 BOX (50814-039-01) / .45 g in 1 BAG | 1 kit | 2018-02-08 | 0000-00-00 | No | No | Current |