Lidocaine and Prilocaine

Product NDC: 52565-007
Requested package NDC: 52565-007-07
11-digit product format: 525650007
Labeler code: 52565
Product ID: 52565-007_de4a6eae-ba69-4f23-9cb1-9a827cbdbd6b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine and Prilocaine
Dosage form: CREAM
Route: TOPICAL
Labeler: Teligent Pharma, Inc.
Application: ANDA205887
Marketing category: ANDA
Marketing start: 2018-06-29
Marketing end: 0000-00-00
Substance: LIDOCAINE; PRILOCAINE
Active strength: 25 mg/g; mg/g
Pharmacologic classes: Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	52565-007	52565-007-07	I	Inactivated by FDA		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 8 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52565-007	52565-007-07	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52565-007	52565-007-07	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52565-007	52565-007-07	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52565-007	52565-007-07	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52565-007	52565-007-07	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52565-007	52565-007-07	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52565-007	52565-007-07	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52565-007	52565-007-07	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

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
A205887-001	LIDOCAINE AND PRILOCAINE	LIDOCAINE; PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL			2018-06-29

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	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2018-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2018-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2018-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2018-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2018-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2018-06-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2018-06-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2018-06-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2018-06-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2018-06-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205887-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205887-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205887-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205887-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205887-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205887-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205887-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205887-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205887-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205887-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205887-001	AB	1	`301d65b070ca…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205887-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205887-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205887-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205887-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205887-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205887-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205887-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205887-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205887-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205887-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205887-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205887-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205887-001	AB	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	A205887-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205887-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205887-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205887-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205887-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205887-001	AB	1	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine and Prilocaine	LIDOCAINE AND PRILOCAINE	PAI Holdings, LLC dba PAI Pharma	58204dfe-f18d-41c4-80e4-eae54fe8d583	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205887 application number: ANDA205887

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52565-007-07	2023-01-30	C162847	48780-1	f386c64a-3e26-0266-e053-dadaa90a7c1a	Lidocaine and Prilocaine USP, 2.5%/2.5%
52565-007-30	2023-01-30	C162847	48780-1	f386c64a-3e26-0266-e053-dadaa90a7c1a	Lidocaine and Prilocaine USP, 2.5%/2.5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52565-007-07	Lidocaine and Prilocaine	5 in 1 CARTON	CREAM	5	3
52565-007-07	Lidocaine and Prilocaine	5 g in 1 TUBE	CREAM	5	3
52565-007-30	Lidocaine and Prilocaine	1 in 1 CARTON	CREAM	1	3
52565-007-30	Lidocaine and Prilocaine	30 g in 1 TUBE	CREAM	30	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52565-007-07	GM - Gram	52565-007	debcb466-ce7a-4db5-a4f8-4c4ede69bee1	1	2018-12-13
52565-007-30	GM - Gram	52565-007	8b71ed7d-d313-4bb5-9a5d-f531d6636dc0	1	2018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52565-007	LIDOCAINE AND PRILOCAINE CREAM [TELIGENT PHARMA, INC.]	3	Legacy NDC, 4 package rows	20181121_7a790e8b-ff12-411f-bacc-9141d4dfef58.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
98PI200987	LIDOCAINE	137-58-6	LIDOCAINE
046O35D44R	PRILOCAINE	721-50-6	PRILOCAINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197877	lidocaine 2.5 % / prilocaine 2.5 % Topical Cream	PSN	7a790e8b-ff12-411f-bacc-9141d4dfef58	3
197877	lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical Cream	SCD	7a790e8b-ff12-411f-bacc-9141d4dfef58	3
197877	lidocaine 2.5 % / prilocaine 2.5 % Topical Cream	SY	7a790e8b-ff12-411f-bacc-9141d4dfef58	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52565-007-07	52565000707	5 TUBE in 1 CARTON (52565-007-07) > 5 g in 1 TUBE	5 tube	2018-06-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prizopak II (X3 Lidocaine 2.5% and Prilocaine 2.5% Cream, USP and Occlusive dressing (20 ct))	PureTek Corporation \| Teligent Pharma, Inc.	2021-10-27	HUMAN PRESCRIPTION DRUG LABEL	3
DermacinRx Empricaine II (Lidocaine 2.5% and Prilocaine 2.5% Cream, USP 30gm and Occlusive Dressing 5ct)	PureTek Corporation \| Teligent Pharma, Inc.	2021-10-08	HUMAN PRESCRIPTION DRUG LABEL	4
Nuvakaan II (Lidocaine 2.5% and Prilocaine 2.5% Cream, USP and Silicone Gel Scar Dressing)	PureTek Corporation \| Teligent Pharma, Inc.	2021-10-08	HUMAN PRESCRIPTION DRUG LABEL	3
Prizotral II™ (Lidocaine 2.5% and Prilocaine 2.5% Cream, Lidocaine HCl 3.88% Cream)	PureTek Corporation \| Teligent Pharma, Inc.	2021-10-08	HUMAN PRESCRIPTION DRUG LABEL	3
Aprizio Pak II	PureTek Corporation \| Teligent Pharma, Inc.	2021-10-08	HUMAN PRESCRIPTION DRUG LABEL	2
Prilovix UltraLite (Lidocaine 2.5% and Prilocaine 2.5% Cream, USP)	Primary Pharmaceuticals, Inc.	2021-01-13	HUMAN PRESCRIPTION DRUG LABEL	2
Prilovix Ultralite Plus Kit (Lidocaine 2.5% and Prilocaine 2.5% Cream, USP)	Primary Pharmaceuticals, Inc.	2021-01-13	HUMAN PRESCRIPTION DRUG LABEL	2
Microvix LP	Primary Pharmaceuticals, Inc. \| Teligent Pharma, Inc \| Rainbow Gold Products, Inc	2020-08-26	HUMAN PRESCRIPTION DRUG LABEL	2
Microvix L	Primary Pharmaceuticals, Inc. \| Teligent Pharma, Inc \| Rainbow Gold Products, Inc	2020-08-24	HUMAN PRESCRIPTION DRUG LABEL	2
Prilopentin -II	PureTek Corporation \| Teligent Pharma, Inc. \| Unit Dose Services	2020-07-02	HUMAN PRESCRIPTION DRUG LABEL	1
Lipritin II	PureTek Corporation \| Teligent Pharma, Inc.	2020-06-05	HUMAN PRESCRIPTION DRUG LABEL	1
Lidocaine and Prilocaine USP, 2.5%/2.5%	Teligent Pharma, Inc.	2018-11-06	HUMAN PRESCRIPTION DRUG LABEL	3