Burn Treatment
- Product NDC
- 49687-0014
- 11-digit product format
- 496870014
- Labeler code
- 49687
- Product ID
- 49687-0014_2b9b619a-5e29-73ef-e063-6394a90a97fe
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- CMC Group Inc.
- Application
- M003
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-08-06
- Substance
- BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
- Active strength
- .13; .5 g/100g; g/100g
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 49687-0014-0 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 49687-0014-0 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 49687-0014-0 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 49687-0014-0 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 49687-0014-0 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 49687-0014-0 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 49687-0014-0 | 1332a3947898… | d4bfe170f9cd… |
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 Treatment
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZALKONIUM CHLORIDE | .13 g/100g |
| LIDOCAINE HYDROCHLORIDE | .5 g/100g |
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 |
|---|---|
| 9dd56b66-48c0-4bcf-a9a8-ba2f1e11ce40 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49687-0014-0 | 2025-01-14 | C162847 | 48780-1 | 1030e365-5a27-111a-e063-dadaa90a10e2 | Burn Treatment |
| 49687-0014-0 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5a27-111a-e063-dadaa90a10e2 | Burn Treatment |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49687-0014-0 | Large ANSI First Aid Kit | 0.9 g in 1 POUCH | CREAM | 9 g | 0.13 g in 100g | 15 |
| 49687-0014-0 | Large ANSI First Aid Kit | 10 in 1 KIT | CREAM | 0.13 g in 100g | 15 | |
| 49687-0014-0 | Standard ANSI First Aid | 0.9 g in 1 POUCH | CREAM | 9 g | 0.13 g in 100g | 13 |
| 49687-0014-0 | Standard ANSI First Aid | 10 in 1 KIT | CREAM | 0.13 g in 100g | 13 | |
| 49687-0014-0 | Burn Treatment | 0.9 g in 1 POUCH | CREAM | 0.9 | 6 | |
| 49687-0014-0 | Burn Treatment | 10 in 1 KIT | CREAM | 10 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49687-0014 | LARGE ANSI FIRST AID KIT (WATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDE) KIT [CMC GROUP, INC.] | 15 | Current NDC, Legacy NDC | 20250406_fa8578c2-a0bc-4e2e-a4f9-d48debfff378.zip |
| 49687-0014 | STANDARD ANSI FIRST AID (WATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDE) KIT [CMC GROUP, INC.] | 13 | Current NDC, Legacy NDC | 20250406_e1ef74bf-8895-4200-a411-f726dcdaa945.zip |
| 49687-0014 | BURN TREATMENT (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [CMC GROUP INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250116_9dd56b66-48c0-4bcf-a9a8-ba2f1e11ce40.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.
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 | fa8578c2-a0bc-4e2e-a4f9-d48debfff378 | 15 |
| 1012100 | benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical Cream | PSN | fa8578c2-a0bc-4e2e-a4f9-d48debfff378 | 15 |
| 1038558 | benzalkonium chloride 0.13 % Medicated Pad | PSN | fa8578c2-a0bc-4e2e-a4f9-d48debfff378 | 15 |
| 581660 | ethanol 62 % Topical Gel | PSN | fa8578c2-a0bc-4e2e-a4f9-d48debfff378 | 15 |
| 797544 | isopropyl alcohol 70 % Medicated Pad | PSN | fa8578c2-a0bc-4e2e-a4f9-d48debfff378 | 15 |
| 1053429 | water 99.1 % Ophthalmic Irrigation Solution | PSN | fa8578c2-a0bc-4e2e-a4f9-d48debfff378 | 15 |
| 204602 | bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment | SCD | fa8578c2-a0bc-4e2e-a4f9-d48debfff378 | 15 |
| 1012100 | benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical Cream | SCD | fa8578c2-a0bc-4e2e-a4f9-d48debfff378 | 15 |
| 1038558 | benzalkonium chloride 1.3 MG/ML Medicated Pad | SCD | fa8578c2-a0bc-4e2e-a4f9-d48debfff378 | 15 |
| 581660 | ethanol 0.62 ML/ML Topical Gel | SCD | fa8578c2-a0bc-4e2e-a4f9-d48debfff378 | 15 |
| 797544 | isopropyl alcohol 0.7 ML/ML Medicated Pad | SCD | fa8578c2-a0bc-4e2e-a4f9-d48debfff378 | 15 |
| 1053429 | water 991 MG/ML Ophthalmic Irrigation Solution | SCD | fa8578c2-a0bc-4e2e-a4f9-d48debfff378 | 15 |
| 204602 | bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment | SY | fa8578c2-a0bc-4e2e-a4f9-d48debfff378 | 15 |
| 1012100 | benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical Cream | SY | fa8578c2-a0bc-4e2e-a4f9-d48debfff378 | 15 |
| 1038558 | benzalkonium chloride 0.13 % Topical Cloth | SY | fa8578c2-a0bc-4e2e-a4f9-d48debfff378 | 15 |
| 1038558 | benzalkonium chloride 0.13 % Topical Swab | SY | fa8578c2-a0bc-4e2e-a4f9-d48debfff378 | 15 |
| 1038558 | benzalkonium chloride 0.13 GM per 100 GM Topical Pad | SY | fa8578c2-a0bc-4e2e-a4f9-d48debfff378 | 15 |
| 1038558 | benzalkonium chloride 0.13 GM per 100 GM Topical Swab | SY | fa8578c2-a0bc-4e2e-a4f9-d48debfff378 | 15 |
| 1038558 | benzalkonium chloride 1 ML per 750 ML Topical Swab | SY | fa8578c2-a0bc-4e2e-a4f9-d48debfff378 | 15 |
| 581660 | ethanol 62 % Topical Gel | SY | fa8578c2-a0bc-4e2e-a4f9-d48debfff378 | 15 |
| 797544 | isopropyl alcohol 70 % Medicated Pad | SY | fa8578c2-a0bc-4e2e-a4f9-d48debfff378 | 15 |
| 797544 | isopropyl alcohol 70 % Topical Cloth | SY | fa8578c2-a0bc-4e2e-a4f9-d48debfff378 | 15 |
| 797544 | isopropyl alcohol 70 % Topical Swab | SY | fa8578c2-a0bc-4e2e-a4f9-d48debfff378 | 15 |
| 1053429 | water 99.05 % Ophthalmic Irrigation Solution | SY | fa8578c2-a0bc-4e2e-a4f9-d48debfff378 | 15 |
| 1053429 | water 99.1 % Ophthalmic Irrigation Solution | SY | fa8578c2-a0bc-4e2e-a4f9-d48debfff378 | 15 |
| 1053429 | water 99.1 ML per 100 ML Ophthalmic Irrigation Solution | SY | fa8578c2-a0bc-4e2e-a4f9-d48debfff378 | 15 |
| 204602 | bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical Ointment | PSN | e1ef74bf-8895-4200-a411-f726dcdaa945 | 13 |
| 1012100 | benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical Cream | PSN | e1ef74bf-8895-4200-a411-f726dcdaa945 | 13 |
| 1038558 | benzalkonium chloride 0.13 % Medicated Pad | PSN | e1ef74bf-8895-4200-a411-f726dcdaa945 | 13 |
| 581660 | ethanol 62 % Topical Gel | PSN | e1ef74bf-8895-4200-a411-f726dcdaa945 | 13 |
| 797544 | isopropyl alcohol 70 % Medicated Pad | PSN | e1ef74bf-8895-4200-a411-f726dcdaa945 | 13 |
| 1053429 | water 99.1 % Ophthalmic Irrigation Solution | PSN | e1ef74bf-8895-4200-a411-f726dcdaa945 | 13 |
| 204602 | bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment | SCD | e1ef74bf-8895-4200-a411-f726dcdaa945 | 13 |
| 1012100 | benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical Cream | SCD | e1ef74bf-8895-4200-a411-f726dcdaa945 | 13 |
| 1038558 | benzalkonium chloride 1.3 MG/ML Medicated Pad | SCD | e1ef74bf-8895-4200-a411-f726dcdaa945 | 13 |
| 581660 | ethanol 0.62 ML/ML Topical Gel | SCD | e1ef74bf-8895-4200-a411-f726dcdaa945 | 13 |
| 797544 | isopropyl alcohol 0.7 ML/ML Medicated Pad | SCD | e1ef74bf-8895-4200-a411-f726dcdaa945 | 13 |
| 1053429 | water 991 MG/ML Ophthalmic Irrigation Solution | SCD | e1ef74bf-8895-4200-a411-f726dcdaa945 | 13 |
| 204602 | bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment | SY | e1ef74bf-8895-4200-a411-f726dcdaa945 | 13 |
| 1012100 | benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical Cream | SY | e1ef74bf-8895-4200-a411-f726dcdaa945 | 13 |
| 1038558 | benzalkonium chloride 0.13 % Topical Cloth | SY | e1ef74bf-8895-4200-a411-f726dcdaa945 | 13 |
| 1038558 | benzalkonium chloride 0.13 % Topical Swab | SY | e1ef74bf-8895-4200-a411-f726dcdaa945 | 13 |
| 1038558 | benzalkonium chloride 0.13 GM per 100 GM Topical Pad | SY | e1ef74bf-8895-4200-a411-f726dcdaa945 | 13 |
| 1038558 | benzalkonium chloride 0.13 GM per 100 GM Topical Swab | SY | e1ef74bf-8895-4200-a411-f726dcdaa945 | 13 |
| 1038558 | benzalkonium chloride 1 ML per 750 ML Topical Swab | SY | e1ef74bf-8895-4200-a411-f726dcdaa945 | 13 |
| 581660 | ethanol 62 % Topical Gel | SY | e1ef74bf-8895-4200-a411-f726dcdaa945 | 13 |
| 797544 | isopropyl alcohol 70 % Medicated Pad | SY | e1ef74bf-8895-4200-a411-f726dcdaa945 | 13 |
| 797544 | isopropyl alcohol 70 % Topical Cloth | SY | e1ef74bf-8895-4200-a411-f726dcdaa945 | 13 |
| 797544 | isopropyl alcohol 70 % Topical Swab | SY | e1ef74bf-8895-4200-a411-f726dcdaa945 | 13 |
| 1053429 | water 99.05 % Ophthalmic Irrigation Solution | SY | e1ef74bf-8895-4200-a411-f726dcdaa945 | 13 |
| 1053429 | water 99.1 % Ophthalmic Irrigation Solution | SY | e1ef74bf-8895-4200-a411-f726dcdaa945 | 13 |
| 1053429 | water 99.1 ML per 100 ML Ophthalmic Irrigation Solution | SY | e1ef74bf-8895-4200-a411-f726dcdaa945 | 13 |
| 1012100 | benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical Cream | PSN | 9dd56b66-48c0-4bcf-a9a8-ba2f1e11ce40 | 6 |
| 1012100 | benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical Cream | SCD | 9dd56b66-48c0-4bcf-a9a8-ba2f1e11ce40 | 6 |
| 1012100 | benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical Cream | SY | 9dd56b66-48c0-4bcf-a9a8-ba2f1e11ce40 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49687-0014-0 | 49687001400 | 10 POUCH in 1 KIT (49687-0014-0) / .9 g in 1 POUCH | 10 pouch | 2016-08-06 | 0000-00-00 | No | No | Current |