Home NDC 0591-2070 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 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.
Historic NDC status page 1 of 1 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019941-001 EMLA LIDOCAINE; PRILOCAINE 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1992-12-30
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N019941-001 EMLA 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1992-12-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019941-001 EMLA 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1992-12-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019941-001 EMLA 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1992-12-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019941-001 EMLA 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1992-12-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019941-001 EMLA 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1992-12-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019941-001 EMLA 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1992-12-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019941-001 EMLA 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1992-12-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019941-001 EMLA 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1992-12-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019941-001 EMLA 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1992-12-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019941-001 EMLA 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1992-12-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019941-001 EMLA 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1992-12-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019941-001 EMLA 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1992-12-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019941-001 EMLA 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1992-12-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019941-001 EMLA 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1992-12-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL AB RLD, RS 1992-12-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL AB RLD, RS 1992-12-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL AB RLD, RS 1992-12-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL AB RLD, RS 1992-12-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL AB RLD, RS 1992-12-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL AB RLD, RS 1992-12-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL AB RLD, RS 1992-12-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL AB RLD, RS 1992-12-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL AB RLD, RS 1992-12-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL AB RLD, RS 1992-12-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL AB RLD, RS 1992-12-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL AB RLD, RS 1992-12-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL AB RLD, RS 1992-12-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL RLD 1992-12-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL RLD 1992-12-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL RLD 1992-12-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL RLD 1992-12-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL RLD 1992-12-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL RLD 1992-12-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL RLD 1992-12-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL RLD 1992-12-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL RLD 1992-12-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL RLD 1992-12-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL RLD 1992-12-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL RLD 1992-12-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL AB RLD, RS 1992-12-30 cb3db0bc1861…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table 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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LIDOCAINE ACTIVE INGREDIENT 98PI200987 LIDOCAINE AND PRILOCAINE CREAM [ACTAVIS PHARMA, INC.] 2 PRILOCAINE ACTIVE INGREDIENT 046O35D44R LIDOCAINE AND PRILOCAINE CREAM [ACTAVIS PHARMA, INC.] 2 LIDOCAINE ACTIVE MOIETY 98PI200987 LIDOCAINE AND PRILOCAINE CREAM [ACTAVIS PHARMA, INC.] 2 PRILOCAINE ACTIVE MOIETY 046O35D44R LIDOCAINE AND PRILOCAINE CREAM [ACTAVIS PHARMA, INC.] 2 CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) INACTIVE INGREDIENT Z135WT9208 LIDOCAINE AND PRILOCAINE CREAM [ACTAVIS PHARMA, INC.] 2 PEG-55 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT 0WZF1506N9 LIDOCAINE AND PRILOCAINE CREAM [ACTAVIS PHARMA, INC.] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I LIDOCAINE AND PRILOCAINE CREAM [ACTAVIS PHARMA, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R LIDOCAINE AND PRILOCAINE CREAM [ACTAVIS PHARMA, INC.] 2 LIDOCAINE ACTIVE INGREDIENT 98PI200987 LIDOCAINE AND PRILOCAINE CREAM [PROFICIENT RX LP] 1 PRILOCAINE ACTIVE INGREDIENT 046O35D44R LIDOCAINE AND PRILOCAINE CREAM [PROFICIENT RX LP] 1 LIDOCAINE ACTIVE MOIETY 98PI200987 LIDOCAINE AND PRILOCAINE CREAM [PROFICIENT RX LP] 1 PRILOCAINE ACTIVE MOIETY 046O35D44R LIDOCAINE AND PRILOCAINE CREAM [PROFICIENT RX LP] 1 CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) INACTIVE INGREDIENT Z135WT9208 LIDOCAINE AND PRILOCAINE CREAM [PROFICIENT RX LP] 1 PEG-55 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT 0WZF1506N9 LIDOCAINE AND PRILOCAINE CREAM [PROFICIENT RX LP] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I LIDOCAINE AND PRILOCAINE CREAM [PROFICIENT RX LP] 1 WATER INACTIVE INGREDIENT 059QF0KO0R LIDOCAINE AND PRILOCAINE CREAM [PROFICIENT RX LP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table 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# Packages# Package NDC, 11-digit format, Description table 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