Lidocaine and Prilocaine
- Product NDC
- 0591-2070
- 11-digit product format
- 005912070
- Labeler code
- 0591
- Product ID
- 0591-2070_5b9e9a34-599f-43b9-b43d-073e8cbfb1b0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lidocaine and prilocaine
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Actavis Pharma, Inc.
- Application
- NDA019941
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2015-04-03
- Marketing end
- 0000-00-00
- Substance
- LIDOCAINE; PRILOCAINE
- Active strength
- 25 mg/g; mg/g
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amide Local Anesthetic [EPC], Amides [CS], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|---|---|---|---|---|---|
| 0591-2070-30 | Lido-Prilo Caine Pack | 1 in 1 CARTON | CREAM | 25 mg in 1g | 3 | |
| 0591-2070-30 | Lido-Prilo Caine Pack | 30 g in 1 TUBE | CREAM | 90 g | 25 mg in 1g | 3 |
| 0591-2070-30 | DermacinRx Prikaan | 1 in 1 CARTON | CREAM | 25 mg in 1g | 2 | |
| 0591-2070-30 | DermacinRx Prikaan | 30 g in 1 TUBE | CREAM | 90 g | 25 mg in 1g | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0591-2070-26 | GM - Gram | 0591-2070 | bb51e17f-846d-442a-b728-c199f1f9fd47 | 1 | 2016-10-06 |
| 0591-2070-30 | GM - Gram | 0591-2070 | 0f2d823c-99da-4b40-ae99-9a2f22e4a165 | 1 | 2015-05-05 |
| 0591-2070-72 | GM - Gram | 0591-2070 | 349eee15-efab-4789-b861-5e303e8f8d78 | 1 | 2015-05-05 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0591-2070 | LIDO-PRILO CAINE PACK (LIDOCAINE AND PRILOCAINE) KIT [TMIG INC.] | 3 | Legacy NDC | 20170109_47ce5ac7-0ee2-48c3-a310-151b5b386a6c.zip |
| 0591-2070 | DERMACINRX PRIKAAN (LIDOCAINE AND PRILOCAINE) KIT [SHORELINE PHARMACEUTICALS, INC.] | 2 | Legacy NDC | 20160920_ded2a2fc-e74c-43a5-9bf1-4b11f68a5254.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197877 | lidocaine 2.5 % / prilocaine 2.5 % Topical Cream | PSN | 47ce5ac7-0ee2-48c3-a310-151b5b386a6c | 3 |
| 197877 | lidocaine 2.5 % / prilocaine 2.5 % Topical Cream | PSN | 4f957014-6a12-4974-9e84-a6cd7715a800 | 3 |
| 197877 | lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical Cream | SCD | 47ce5ac7-0ee2-48c3-a310-151b5b386a6c | 3 |
| 197877 | lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical Cream | SCD | 4f957014-6a12-4974-9e84-a6cd7715a800 | 3 |
| 197877 | lidocaine 2.5 % / prilocaine 2.5 % Topical Cream | SY | 47ce5ac7-0ee2-48c3-a310-151b5b386a6c | 3 |
| 197877 | lidocaine 2.5 % / prilocaine 2.5 % Topical Cream | SY | 4f957014-6a12-4974-9e84-a6cd7715a800 | 3 |
| 197877 | lidocaine 2.5 % / prilocaine 2.5 % Topical Cream | PSN | ded2a2fc-e74c-43a5-9bf1-4b11f68a5254 | 2 |
| 197877 | lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical Cream | SCD | ded2a2fc-e74c-43a5-9bf1-4b11f68a5254 | 2 |
| 197877 | lidocaine 2.5 % / prilocaine 2.5 % Topical Cream | SY | ded2a2fc-e74c-43a5-9bf1-4b11f68a5254 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0591-2070-26 | 00591207026 | 1 TUBE in 1 CARTON (0591-2070-26) > 5 g in 1 TUBE | 1 tube | 2015-04-03 | 0000-00-00 | No | No | Current |
| 0591-2070-30 | 00591207030 | 1 TUBE in 1 CARTON (0591-2070-30) > 30 g in 1 TUBE | 1 tube | 2015-04-03 | 0000-00-00 | No | No | Current |
| 0591-2070-72 | 00591207072 | 5 TUBE in 1 CARTON (0591-2070-72) > 5 g in 1 TUBE | 5 tube | 2015-04-03 | 0000-00-00 | No | No | Current |