Burn
- Product NDC
- 50382-022
- 11-digit product format
- 503820022
- Labeler code
- 50382
- Product ID
- 50382-022_ee8585d7-e13a-a297-e053-2995a90ab837
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Lidocaine Hydrochloride and Benzalkonium Chloride
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Galentic Pharma (India) Private Limited
- Application
- part348
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2015-09-01
- Marketing end
- 0000-00-00
- Substance
- BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
- Active strength
- 1 mg/g; mg/g
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50382-022-11 | 50382002211 | 10 PACKET in 1 CARTON (50382-022-11) > .9 g in 1 PACKET | 10 packet | 2016-04-14 | 0000-00-00 | No | No | Current |
| 50382-022-12 | 50382002212 | 25 PACKET in 1 CARTON (50382-022-12) > .9 g in 1 PACKET | 25 packet | 2016-04-14 | 0000-00-00 | No | No | Current |
| 50382-022-13 | 50382002213 | 144 PACKET in 1 CARTON (50382-022-13) > .9 g in 1 PACKET | 144 packet | 2015-09-01 | 0000-00-00 | No | No | Current |