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

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
A200675-001	LIDOCAINE	LIDOCAINE	5%	PATCH / TOPICAL	AB		2012-08-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A200675-001	AB

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A200675-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200675-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200675-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200675-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200675-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200675-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200675-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200675-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200675-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200675-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200675-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200675-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200675-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200675-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200675-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200675-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200675-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200675-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200675-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200675-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200675-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200675-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200675-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200675-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200675-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200675-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200675-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200675-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200675-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200675-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200675-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200675-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200675-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200675-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200675-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200675-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200675-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200675-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200675-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200675-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Lidocaine

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE	50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
98PI200987	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1745091	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4d04052c-3e0a-469a-9265-99604f13e507	Available on FDA.report

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 [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
LIDOCAINE	ACTIVE INGREDIENT	98PI200987	LIDOCAINE PATCH [DIRECT RX]	1
LIDOCAINE	ACTIVE MOIETY	98PI200987	LIDOCAINE PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
LIDOCAINE	ACTIVE MOIETY	98PI200987	LIDOCAINE PATCH [DIRECT RX]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	LIDOCAINE PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	LIDOCAINE PATCH [DIRECT RX]	1
DIHYDROXYALUMINUM AMINOACETATE	INACTIVE INGREDIENT	DO250MG0W6	LIDOCAINE PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
DIHYDROXYALUMINUM AMINOACETATE	INACTIVE INGREDIENT	DO250MG0W6	LIDOCAINE PATCH [DIRECT RX]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	LIDOCAINE PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	LIDOCAINE PATCH [DIRECT RX]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LIDOCAINE PATCH [DIRECT RX]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LIDOCAINE PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	LIDOCAINE PATCH [DIRECT RX]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	LIDOCAINE PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	LIDOCAINE PATCH [DIRECT RX]	1
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	LIDOCAINE PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	LIDOCAINE PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	LIDOCAINE PATCH [DIRECT RX]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	LIDOCAINE PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	LIDOCAINE PATCH [DIRECT RX]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LIDOCAINE PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LIDOCAINE PATCH [DIRECT RX]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	LIDOCAINE PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	LIDOCAINE PATCH [DIRECT RX]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	LIDOCAINE PATCH [DIRECT RX]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	LIDOCAINE PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
TARTARIC ACID	INACTIVE INGREDIENT	W4888I119H	LIDOCAINE PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
TARTARIC ACID	INACTIVE INGREDIENT	W4888I119H	LIDOCAINE PATCH [DIRECT RX]	1
UREA	INACTIVE INGREDIENT	8W8T17847W	LIDOCAINE PATCH [DIRECT RX]	1
UREA	INACTIVE INGREDIENT	8W8T17847W	LIDOCAINE PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	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

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.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tridacaine II	LIDOCAINE	Trifluent Pharma LLC	1e940ba6-3916-4fc4-8886-481fc9685fc1	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675
Lidocaine	LIDOCAINE	PureTek Corporation	85e72943-6989-42f4-b519-a3ebbf4bc777	2025-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675
Lidocaine	LIDOCAINE	Cardinal Health 107, LLC	eb808fdf-0420-45e9-ad17-8380d49d5c21	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675
Lidocaine	LIDOCAINE	Actavis Pharma, Inc.	c18799cd-9e11-4196-9ab1-0a2a84585e56	2025-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	4e856dd5-f2fa-4acb-a205-f87baf26b8cc	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	1d28d687-695e-4cd9-97e2-7d4fdab9772a	2024-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	6d7fdc43-e493-449e-9af6-825e584b547a	2023-11-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675
Lidocaine	LIDOCAINE	Asclemed USA, Inc.	80dadfb5-cbe6-475f-9980-a1b255982753	2022-10-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675
Lidocaine	LIDOCAINE	Actavis Pharma, Inc.	4d04052c-3e0a-469a-9265-99604f13e507	2022-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675 ndc (product): 0591-3525
Lidocaine	LIDOCAINE	AVKARE	ec6a4720-9821-c0fc-e053-2995a90a05df	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675

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
Tridacaine™ II	Trifluent Pharma LLC	2026-06-12	HUMAN PRESCRIPTION DRUG LABEL	8
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
Lidocaine Patch A200675	St. Mary's Medical Park Pharmacy	2024-12-12	HUMAN PRESCRIPTION DRUG LABEL	3
Lidocaine Patch A200675	Preferred Pharmaceuticals Inc.	2024-06-19	HUMAN PRESCRIPTION DRUG LABEL	5
Lidocaine Patch A200675	Bryant Ranch Prepack	2024-06-05	HUMAN PRESCRIPTION DRUG LABEL	105
Lidocaine Patch A200675	REMEDYREPACK INC.	2024-02-14	HUMAN PRESCRIPTION DRUG LABEL	6
Lidocaine Patch A200675	Trifluent Pharma LLC	2024-02-09	HUMAN PRESCRIPTION DRUG LABEL	2
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
Prilo Patch-II	PureTek Corporation	2021-10-08	HUMAN PRESCRIPTION DRUG LABEL	4
Zilacaine Patch	PureTek Corporation \| Actavis Laboratories UT, Inc.	2021-03-30	HUMAN PRESCRIPTION DRUG LABEL	4
Lidocaine Patch	NuCare Pharmaceuticals,Inc.	2021-01-29	HUMAN PRESCRIPTION DRUG LABEL	2
Gabacaine	PureTek Corporation \| Actavis Laboratories UT, Inc.	2020-11-16	HUMAN PRESCRIPTION DRUG LABEL	3
Zenevix	Primary Pharmaceuticals, Inc. \| Rainbow Gold Products, Inc.	2020-08-24	HUMAN PRESCRIPTION DRUG LABEL	3
Dermalid	Primary Pharmaceuticals, Inc. \| Rainbow Gold Products, Inc.	2020-08-04	HUMAN PRESCRIPTION DRUG LABEL	1
Lidovix	Primary Pharmaceuticals, Inc. \| Actavis Laboratories UT, Inc \| Rainbow Gold	2019-08-07	HUMAN PRESCRIPTION DRUG LABEL	1
Lidocaine Patch	Lake Erie Medical DBA Quality Care Products LLC	2019-03-13	HUMAN PRESCRIPTION DRUG LABEL	3
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