Burn Cream
- Product NDC
- 58228-7010
- Requested package NDC
- 58228-7010-2
- 11-digit product format
- 582287010
- Labeler code
- 58228
- Product ID
- 58228-7010_4e553aa3-41d4-1512-e063-6394a90ab870
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzalkonium Chloride, Lidocaine HCI
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Prostat First Aid
- Application
- M003
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-01-13
- Substance
- BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
- Active strength
- .0013; .005 g/g; g/g
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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
- Burn Cream
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZALKONIUM CHLORIDE | .0013 g/g |
| LIDOCAINE HYDROCHLORIDE | .005 g/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| F5UM2KM3W7 | Internal UNII lookup |
| V13007Z41A | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1012100 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4cd5d67d-43d8-f6d2-e063-6394a90a4070 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 070fbed5-7088-434a-a7ce-f2a64d8d40ac | Product name | 2 | 20260107 |
| bee66ce1-adb7-9d3b-67d9-582e4c54e80f | Product name | 5 | 20250819 |
| 860a93dc-4863-49cc-b284-6bbe8191bc48 | Product name | 4 | 20250214 |
| eaba870a-6a9d-442e-8643-87b3f558a451 | Product name | 1 | 20250117 |
| 9b4cf230-fd05-41d5-98c6-5db9ecb27b86 | Product name | 1 | 20230117 |
| 7d755fa1-1087-4dcd-98f0-6d4bba479a57 | Product name | 3 | 20210602 |
| aed701d5-9c75-dfaf-7154-cde46179faea | Product name | 9 | 20200313 |
| fa8b5901-e681-426f-82fe-54f6d81ec698 | Product name | 4 | 20180619 |
| 332d03e4-aa24-4b11-841a-02bf41081920 | Product name | 1 | 20171221 |
| c08ab52f-2fc8-4409-9d9f-ed8edc0bd070 | Product name | 1 | 20171221 |
| 68ed98f8-24c2-44a0-944a-6d36e82ce25a | Product name | 1 | 20141222 |
| 1cd42bc2-a430-c72b-636d-991b235fbf80 | Product name | 1 | 20140508 |
| 49fa150c-f0de-cce7-3d9c-993ed81c5698 | Product name | 1 | 20140508 |
| 4d7ae718-ed00-bae8-2abe-9eaec1eef7ff | Product name | 1 | 20140508 |
| 9137811f-f279-8640-5aeb-99fa2145d64d | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58228-7010-1 | Burn Cream | 10 in 1 BOX | CREAM | 10 | 2 | |
| 58228-7010-1 | Burn Cream | 0.9 g in 1 PACKET | CREAM | 0.9 | 2 | |
| 58228-7010-2 | Burn Cream | 0.9 g in 1 PACKET | CREAM | 0.9 | 2 | |
| 58228-7010-2 | Burn Cream | 2000 in 1 BAG | CREAM | 2000 | 2 |
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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1012100 | benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical Cream | PSN | 4cd5d67d-43d8-f6d2-e063-6394a90a4070 | 2 |
| 1012100 | benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical Cream | SCD | 4cd5d67d-43d8-f6d2-e063-6394a90a4070 | 2 |
| 1012100 | benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical Cream | SY | 4cd5d67d-43d8-f6d2-e063-6394a90a4070 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 58228-7010-2 | 58228701002 | 2000 PACKET in 1 BAG (58228-7010-2) / .9 g in 1 PACKET | 2000 packet | 2026-01-13 | No | No | Current |