Lidocaine

Product NDC: 0591-3525
11-digit product format: 005913525
Labeler code: 0591
Product ID: 0591-3525_7e68f396-fae0-4c14-91cc-8a94810120d0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine
Dosage form: PATCH
Route: TOPICAL
Labeler: Actavis Pharma, Inc.
Application: ANDA200675
Marketing category: ANDA
Marketing start: 2013-09-15
Marketing end: 2027-08-31
Substance: LIDOCAINE
Active strength: 50 mg/g
Pharmacologic classes: Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag: No
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Lidocaine

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE	50 mg/g

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	98PI200987
Rxcui	1745091

DailyMed Product Concepts#

Product concept, Relation, Version table
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
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
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
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0591-3525-11	Lidocaine	1 g in 1 POUCH	PATCH	1		16
0591-3525-30	Lidocaine	30 in 1 CARTON	PATCH	30		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-3525-11	EA - Each	0591-3525	5acb4b50-7c80-4023-baea-b0a90c3d8057	1	2013-10-17
0591-3525-30	EA - Each	0591-3525	4540e795-0ae0-4cd7-817f-db03cfdfe3c3	1	2013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LIDOCAINE	ACTIVE INGREDIENT	98PI200987	LIDOCAINE PATCH [BRYANT RANCH PREPACK]	1000
LIDOCAINE	ACTIVE MOIETY	98PI200987	LIDOCAINE PATCH [BRYANT RANCH PREPACK]	1000
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	LIDOCAINE PATCH [BRYANT RANCH PREPACK]	1000
DIHYDROXYALUMINUM AMINOACETATE	INACTIVE INGREDIENT	DO250MG0W6	LIDOCAINE PATCH [BRYANT RANCH PREPACK]	1000
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	LIDOCAINE PATCH [BRYANT RANCH PREPACK]	1000
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LIDOCAINE PATCH [BRYANT RANCH PREPACK]	1000
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	LIDOCAINE PATCH [BRYANT RANCH PREPACK]	1000
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	LIDOCAINE PATCH [BRYANT RANCH PREPACK]	1000
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	LIDOCAINE PATCH [BRYANT RANCH PREPACK]	1000
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	LIDOCAINE PATCH [BRYANT RANCH PREPACK]	1000
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LIDOCAINE PATCH [BRYANT RANCH PREPACK]	1000
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	LIDOCAINE PATCH [BRYANT RANCH PREPACK]	1000
SORBITOL	INACTIVE INGREDIENT	506T60A25R	LIDOCAINE PATCH [BRYANT RANCH PREPACK]	1000
TARTARIC ACID	INACTIVE INGREDIENT	W4888I119H	LIDOCAINE PATCH [BRYANT RANCH PREPACK]	1000
UREA	INACTIVE INGREDIENT	8W8T17847W	LIDOCAINE PATCH [BRYANT RANCH PREPACK]	1000
LIDOCAINE	ACTIVE INGREDIENT	98PI200987	LIDOCAINE PATCH [ACTAVIS PHARMA, INC.]	9
LIDOCAINE	ACTIVE MOIETY	98PI200987	LIDOCAINE PATCH [ACTAVIS PHARMA, INC.]	9
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	INACTIVE INGREDIENT	K679OBS311	LIDOCAINE PATCH [ACTAVIS PHARMA, INC.]	9
DIHYDROXYALUMINUM AMINOACETATE	INACTIVE INGREDIENT	DO250MG0W6	LIDOCAINE PATCH [ACTAVIS PHARMA, INC.]	9
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	LIDOCAINE PATCH [ACTAVIS PHARMA, INC.]	9
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LIDOCAINE PATCH [ACTAVIS PHARMA, INC.]	9
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	LIDOCAINE PATCH [ACTAVIS PHARMA, INC.]	9
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	LIDOCAINE PATCH [ACTAVIS PHARMA, INC.]	9
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	LIDOCAINE PATCH [ACTAVIS PHARMA, INC.]	9
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	LIDOCAINE PATCH [ACTAVIS PHARMA, INC.]	9
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LIDOCAINE PATCH [ACTAVIS PHARMA, INC.]	9
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	LIDOCAINE PATCH [ACTAVIS PHARMA, INC.]	9
SORBITOL	INACTIVE INGREDIENT	506T60A25R	LIDOCAINE PATCH [ACTAVIS PHARMA, INC.]	9
TARTARIC ACID	INACTIVE INGREDIENT	W4888I119H	LIDOCAINE PATCH [ACTAVIS PHARMA, INC.]	9
UREA	INACTIVE INGREDIENT	8W8T17847W	LIDOCAINE PATCH [ACTAVIS PHARMA, INC.]	9
LIDOCAINE	ACTIVE INGREDIENT	98PI200987	LIDOCAINE PATCH [UNIT DOSE SERVICES]	2
LIDOCAINE	ACTIVE MOIETY	98PI200987	LIDOCAINE PATCH [UNIT DOSE SERVICES]	2
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	LIDOCAINE PATCH [UNIT DOSE SERVICES]	2
DIHYDROXYALUMINUM AMINOACETATE	INACTIVE INGREDIENT	DO250MG0W6	LIDOCAINE PATCH [UNIT DOSE SERVICES]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	LIDOCAINE PATCH [UNIT DOSE SERVICES]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LIDOCAINE PATCH [UNIT DOSE SERVICES]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	LIDOCAINE PATCH [UNIT DOSE SERVICES]	2
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	LIDOCAINE PATCH [UNIT DOSE SERVICES]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	LIDOCAINE PATCH [UNIT DOSE SERVICES]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	LIDOCAINE PATCH [UNIT DOSE SERVICES]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LIDOCAINE PATCH [UNIT DOSE SERVICES]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	LIDOCAINE PATCH [UNIT DOSE SERVICES]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	LIDOCAINE PATCH [UNIT DOSE SERVICES]	2
TARTARIC ACID	INACTIVE INGREDIENT	W4888I119H	LIDOCAINE PATCH [UNIT DOSE SERVICES]	2
UREA	INACTIVE INGREDIENT	8W8T17847W	LIDOCAINE PATCH [UNIT DOSE SERVICES]	2
LIDOCAINE	ACTIVE INGREDIENT	98PI200987	LIDOCAINE PATCH [DIRECT RX]	1
LIDOCAINE	ACTIVE MOIETY	98PI200987	LIDOCAINE PATCH [DIRECT RX]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	LIDOCAINE PATCH [DIRECT RX]	1
DIHYDROXYALUMINUM AMINOACETATE	INACTIVE INGREDIENT	DO250MG0W6	LIDOCAINE PATCH [DIRECT RX]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	LIDOCAINE PATCH [DIRECT RX]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LIDOCAINE PATCH [DIRECT RX]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	LIDOCAINE PATCH [DIRECT RX]	1
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	LIDOCAINE PATCH [DIRECT RX]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	LIDOCAINE PATCH [DIRECT RX]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	LIDOCAINE PATCH [DIRECT RX]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LIDOCAINE PATCH [DIRECT RX]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	LIDOCAINE PATCH [DIRECT RX]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	LIDOCAINE PATCH [DIRECT RX]	1
TARTARIC ACID	INACTIVE INGREDIENT	W4888I119H	LIDOCAINE PATCH [DIRECT RX]	1
UREA	INACTIVE INGREDIENT	8W8T17847W	LIDOCAINE PATCH [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-3525	LIDOCAINE PATCH [ACTAVIS PHARMA, INC.]	15	Current NDC, Legacy NDC, 2 package rows	20250206_4d04052c-3e0a-469a-9265-99604f13e507.zip
0591-3525	ELEMAR PATCH (LIDOCAINE) KIT [V2 PHARMA, LLC]	11	Current NDC, Legacy NDC	20250101_3de6bb95-3673-45c4-bf11-90ec858c37d9.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
98PI200987	LIDOCAINE	137-58-6	LIDOCAINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1745091	lidocaine 5 % Medicated Patch	PSN	6d7fdc43-e493-449e-9af6-825e584b547a	1015
1745091	lidocaine 0.05 MG/MG Medicated Patch	SCD	6d7fdc43-e493-449e-9af6-825e584b547a	1015
1745091	lidocaine 5 % Medicated Patch	SY	6d7fdc43-e493-449e-9af6-825e584b547a	1015
1745091	lidocaine 5 % Medicated Patch	PSN	1d28d687-695e-4cd9-97e2-7d4fdab9772a	105
1745091	lidocaine 0.05 MG/MG Medicated Patch	SCD	1d28d687-695e-4cd9-97e2-7d4fdab9772a	105
1745091	lidocaine 5 % Medicated Patch	SY	1d28d687-695e-4cd9-97e2-7d4fdab9772a	105
1745091	lidocaine 5 % Medicated Patch	PSN	4d04052c-3e0a-469a-9265-99604f13e507	16
1745091	lidocaine 0.05 MG/MG Medicated Patch	SCD	4d04052c-3e0a-469a-9265-99604f13e507	16
1745091	lidocaine 5 % Medicated Patch	SY	4d04052c-3e0a-469a-9265-99604f13e507	16
1745091	lidocaine 5 % Medicated Patch	PSN	85e72943-6989-42f4-b519-a3ebbf4bc777	12
1745091	lidocaine 0.05 MG/MG Medicated Patch	SCD	85e72943-6989-42f4-b519-a3ebbf4bc777	12
1745091	lidocaine 5 % Medicated Patch	SY	85e72943-6989-42f4-b519-a3ebbf4bc777	12
1745091	lidocaine 5 % Medicated Patch	PSN	eb808fdf-0420-45e9-ad17-8380d49d5c21	8
1745091	lidocaine 0.05 MG/MG Medicated Patch	SCD	eb808fdf-0420-45e9-ad17-8380d49d5c21	8
1745091	lidocaine 5 % Medicated Patch	SY	eb808fdf-0420-45e9-ad17-8380d49d5c21	8
1745091	lidocaine 5 % Medicated Patch	PSN	20b8df6b-34d3-468c-9726-39fe947da274	7
1745091	lidocaine 0.05 MG/MG Medicated Patch	SCD	20b8df6b-34d3-468c-9726-39fe947da274	7
1745091	lidocaine 5 % Medicated Patch	SY	20b8df6b-34d3-468c-9726-39fe947da274	7
1745091	lidocaine 5 % Medicated Patch	PSN	4f80c162-444f-4829-a13a-30df0a48297e	6
1745091	lidocaine 0.05 MG/MG Medicated Patch	SCD	4f80c162-444f-4829-a13a-30df0a48297e	6
1745091	lidocaine 5 % Medicated Patch	SY	4f80c162-444f-4829-a13a-30df0a48297e	6
1745091	lidocaine 5 % Medicated Patch	PSN	1e940ba6-3916-4fc4-8886-481fc9685fc1	5
2678310	Tridacaine 5 % Medicated Patch	PSN	1e940ba6-3916-4fc4-8886-481fc9685fc1	5
2678310	lidocaine 0.05 MG/MG Medicated Patch [Tridacaine]	SBD	1e940ba6-3916-4fc4-8886-481fc9685fc1	5
1745091	lidocaine 0.05 MG/MG Medicated Patch	SCD	1e940ba6-3916-4fc4-8886-481fc9685fc1	5
1745091	lidocaine 5 % Medicated Patch	SY	1e940ba6-3916-4fc4-8886-481fc9685fc1	5
2678310	Tridacaine 0.05 MG/MG Medicated Patch	SY	1e940ba6-3916-4fc4-8886-481fc9685fc1	5
2678310	Tridacaine 5 % Medicated Patch	SY	1e940ba6-3916-4fc4-8886-481fc9685fc1	5
1745091	lidocaine 5 % Medicated Patch	PSN	5c750890-d68b-aeea-e053-2a91aa0af70b	2
1745091	lidocaine 5 % Medicated Patch	PSN	103f88dc-d705-4993-bcab-e2fc12ff6024	2
1745091	lidocaine 5 % Medicated Patch	PSN	80dadfb5-cbe6-475f-9980-a1b255982753	2
1745091	lidocaine 5 % Medicated Patch	PSN	8112b45f-b6b3-4c68-bbd0-4a6d65d73bbe	2
1745091	lidocaine 0.05 MG/MG Medicated Patch	SCD	80dadfb5-cbe6-475f-9980-a1b255982753	2
1745091	lidocaine 0.05 MG/MG Medicated Patch	SCD	103f88dc-d705-4993-bcab-e2fc12ff6024	2
1745091	lidocaine 0.05 MG/MG Medicated Patch	SCD	8112b45f-b6b3-4c68-bbd0-4a6d65d73bbe	2
1745091	lidocaine 0.05 MG/MG Medicated Patch	SCD	5c750890-d68b-aeea-e053-2a91aa0af70b	2
1745091	lidocaine 5 % Medicated Patch	SY	80dadfb5-cbe6-475f-9980-a1b255982753	2
1745091	lidocaine 5 % Medicated Patch	SY	8112b45f-b6b3-4c68-bbd0-4a6d65d73bbe	2
1745091	lidocaine 5 % Medicated Patch	SY	5c750890-d68b-aeea-e053-2a91aa0af70b	2
1745091	lidocaine 5 % Medicated Patch	SY	103f88dc-d705-4993-bcab-e2fc12ff6024	2
1745091	lidocaine 5 % Medicated Patch	PSN	7d78d50e-b62b-09de-e053-2991aa0ad9bf	1
1745091	lidocaine 0.05 MG/MG Medicated Patch	SCD	7d78d50e-b62b-09de-e053-2991aa0ad9bf	1
1745091	lidocaine 5 % Medicated Patch	SY	7d78d50e-b62b-09de-e053-2991aa0ad9bf	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-3525-11	00591352511	1 g in 1 POUCH	1 g					Historical
0591-3525-30	00591352530	30 POUCH in 1 CARTON (0591-3525-30) / 1 g in 1 POUCH (0591-3525-11)	30 pouch	2013-09-15	2027-08-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lidocaine Patch 5% Rx Only	PureTek Corporation	2025-12-12	HUMAN PRESCRIPTION DRUG LABEL	12
Lidocaine Patch A200675	Cardinal Health 107, LLC	2025-10-20	HUMAN PRESCRIPTION DRUG LABEL	8
Tridacaine™ II	Trifluent Pharma LLC	2025-10-13	HUMAN PRESCRIPTION DRUG LABEL	5
Lidocaine Patch A200675	Bryant Ranch Prepack	2024-06-05	HUMAN PRESCRIPTION DRUG LABEL	105
Lidocaine Patch A200675	Bryant Ranch Prepack	2023-11-16	HUMAN PRESCRIPTION DRUG LABEL	1015
Lidocaine Patch A200675	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2022-10-12	HUMAN PRESCRIPTION DRUG LABEL	2
Lidocaine Patch A200675	Actavis Pharma, Inc.	2022-04-30	HUMAN PRESCRIPTION DRUG LABEL	16
Lidocaine Patch A200675	Unit Dose Services	2022-01-27	HUMAN PRESCRIPTION DRUG LABEL	2
Lidocaine Patch	NuCare Pharmaceuticals,Inc.	2021-01-29	HUMAN PRESCRIPTION DRUG LABEL	2
Lidocaine Patch	medsource pharmaceuticals	2018-12-20	HUMAN PRESCRIPTION DRUG LABEL	1
Lidocaine Patch	Unit Dose Services	2018-01-23	HUMAN PRESCRIPTION DRUG LABEL	7
Lidocaine Patch	A-S Medication Solutions	2017-11-22	HUMAN PRESCRIPTION DRUG LABEL	6
LIDOCAINE	DIRECT RX	2016-10-24	HUMAN PRESCRIPTION DRUG LABEL	2

Lidocaine

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#