Application 022114

Type: NDA
Sponsor: POWDER PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZINGO	LIDOCAINE HYDROCHLORIDE	SYSTEM;INTRADERMAL	0.5MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N022114-001	ZINGO	LIDOCAINE HYDROCHLORIDE	0.5MG	SYSTEM / INTRADERMAL			2007-08-16

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N022114-001	8540665	2029-10-22	U-1438	2013-10-09
N022114-001	9358338	2035-04-27	U-1870	2016-07-06
N022114-001	9370622	2035-09-28	U-1870	2016-07-06

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022114-001	ZINGO	0.5MG	SYSTEM / INTRADERMAL	2007-08-16	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022114-001	8540665	2029-10-22	U-1438	2013-10-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022114-001	9358338	2035-04-27	U-1870	2016-07-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022114-001	9370622	2035-09-28	U-1870	2016-07-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022114-001	8540665	2029-10-22	U-1438	2013-10-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022114-001	9358338	2035-04-27	U-1870	2016-07-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022114-001	9370622	2035-09-28	U-1870	2016-07-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022114-001	8540665	2029-10-22	U-1438	2013-10-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022114-001	9358338	2035-04-27	U-1870	2016-07-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022114-001	9370622	2035-09-28	U-1870	2016-07-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022114-001	8540665	2029-10-22	U-1438	2013-10-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022114-001	9358338	2035-04-27	U-1870	2016-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022114-001	9370622	2035-09-28	U-1870	2016-07-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022114-001	8540665	2029-10-22	U-1438	2013-10-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022114-001	9358338	2035-04-27	U-1870	2016-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022114-001	9370622	2035-09-28	U-1870	2016-07-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022114-001	8540665	2029-10-22	U-1438	2013-10-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022114-001	9358338	2035-04-27	U-1870	2016-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022114-001	9370622	2035-09-28	U-1870	2016-07-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022114-001	8540665	2029-10-22	U-1438	2013-10-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022114-001	9358338	2035-04-27	U-1870	2016-07-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022114-001	9370622	2035-09-28	U-1870	2016-07-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022114-001	8540665	2029-10-22	U-1438	2013-10-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022114-001	9358338	2035-04-27	U-1870	2016-07-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022114-001	9370622	2035-09-28	U-1870	2016-07-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022114-001	8540665	2029-10-22	U-1438	2013-10-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022114-001	9358338	2035-04-27	U-1870	2016-07-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022114-001	9370622	2035-09-28	U-1870	2016-07-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022114-001	8540665	2029-10-22	U-1438	2013-10-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022114-001	9358338	2035-04-27	U-1870	2016-07-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022114-001	9370622	2035-09-28	U-1870	2016-07-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022114-001	8540665	2029-10-22	U-1438	2013-10-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022114-001	9358338	2035-04-27	U-1870	2016-07-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022114-001	9370622	2035-09-28	U-1870	2016-07-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022114-001	8540665	2029-10-22	U-1438	2013-10-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022114-001	9358338	2035-04-27	U-1870	2016-07-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022114-001	9370622	2035-09-28	U-1870	2016-07-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022114-001	8540665	2029-10-22	U-1438	2013-10-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022114-001	9358338	2035-04-27	U-1870	2016-07-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022114-001	9370622	2035-09-28	U-1870	2016-07-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022114-001	8540665	2029-10-22	U-1438	2013-10-09	`301d65b070ca…`

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 9 of 15 · 299 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine hydrochloride	LIDOCAINE HYDROCHLORIDE	NorthStar RxLLC	6a7fa6c5-b550-46ac-99a3-5c49339e6dbd	2025-02-19	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Eugia US LLC	9916b09d-a116-469d-92d5-60e50ea9782b	2025-02-07	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
TheraCare Pain Relieving Lidocaine Cream	LIDOCAINE HYDROCHLORIDE	Veridian Healthcare	2d42192b-8889-a896-e063-6294a90a4fc8	2025-02-03	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Eugia US LLC	ccc38d8a-43fd-44c0-985e-32af9ed956ab	2025-02-03	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	d5e23ede-957c-4a32-b1c6-268acb773c31	2025-01-31	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
INTIMALE LIDOCAINE DELAY	LIDOCAINE HYDROCHLORIDE	SKINS SEXUAL HEALTH LIMITED	5ddd7d56-bf51-462b-afcd-944861e49781	2025-01-28	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Meijer Odor Free Analgesic Pain Relieving Topical Analgesic	LIDOCAINE HYDROCHLORIDE	Meijer Distribution, Inc	6288efea-f636-4eea-bb9f-78aa2f9af54a	2025-01-14	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
IKONIK TONIK	LIDOCAINE HYDROCHLORIDE	IKONIK CARE, LLC	122fdfe8-b5fa-46d1-9fd9-3df9887ed320	2025-01-14	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Burn Jel	LIDOCAINE HYDROCHLORIDE	Water-Jel Technologies	ff621b46-2342-41db-994d-851a09796d08	2025-01-06	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine hydrochloride	LIDOCAINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f4c19cf5-c8b1-5e9f-e053-2995a90aee53	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
HealthWise 4% Lidocaine Cream	LIDOCAINE HYDROCHLORIDE	Veridian Healthcare	0fb2af30-7f2d-c7c4-e063-6294a90a37f7	2024-12-19	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Viscous	LIDOCAINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	79b42076-359d-4258-b1d8-f40e67ac5424	2024-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Serum X	LIDOCAINE HYDROCHLORIDE	AO Biologix, LLC	e07b6268-6400-6849-e053-2a95a90a8b3e	2024-12-11	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	McKesson Corporation dba SKY Packaging	903cd7bd-6c3d-4068-bb24-e91b1ca1393d	2024-12-10	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Bryant Ranch Prepack	f581248d-697d-4174-aa42-afdf4ecce02e	2024-12-05	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
PO First Aid Series BURN	LIDOCAINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	f1c349a8-216d-4233-922e-c95329a33d1e	2024-12-05	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
TheraCare Pain Relieving Lidocaine Cream	LIDOCAINE HYDROCHLORIDE	Veridian Healthcare	242204d3-efc7-f7a9-e063-6294a90a5af1	2024-11-27	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
First Aid Only Burn	LIDOCAINE HYDROCHLORIDE	Acme United Corporation	9af39fcd-0a57-26d0-e053-2a95a90a99a0	2024-11-17	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
XYLOCAINE MPF	LIDOCAINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	199ac3eb-1fa5-9cf5-e063-6394a90a7228	2024-11-15	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Meijer Pain Relieving Max Strength with Lavender Essential Oil Analgesic	LIDOCAINE HYDROCHLORIDE	Meijer Distribution, Inc	e688967e-799a-4fc8-a19a-f0012b90e76b	2024-11-15	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
61388-001	Zingo	lidocaine hydrochloride monohydrate	Powder Pharmaceuticals Inc.	NDA	Current
69420-1230	Lidocaine Hydrochloride Monohydrate	Lidocaine Hydrochloride Monohydrate	SA3, LLC	NDA AUTHORIZED GENERIC	Current
69420-1230	Lidocaine Hydrochloride Monohydrate	Lidocaine Hydrochloride Monohydrate	SA3, LLC	NDA AUTHORIZED GENERIC	Current
70645-123	Zingo	lidocaine hydrochloride monohydrate	7T Pharma LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84511	SUPPL	2025-12-23
84502	SUPPL	2025-12-23
56397	SUPPL	2018-11-09
56274	SUPPL	2018-11-05
21938	ORIG	2010-03-02
16963	SUPPL	2009-01-14
29267	SUPPL	2009-01-12
29266	ORIG	2007-08-17
16962	ORIG	2007-08-17