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 6 of 15 · 299 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Launch Medical	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	293ef514-44c1-43ac-9a81-c30e34ad39e5	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Tattoo Numbing Cream Co	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	2a64b3ef-ed2d-49db-996d-f63ffecb5a1e	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Painless Tattoo Numbing	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	efd3289f-dfb2-487c-a76f-00fe8af414e3	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Now Numb Numbing Cream	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	fed833f5-4f76-46e8-8ae1-655a9e576f70	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Painless Tattoo Numbing Cream	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	852504ec-d4fa-4cae-ba89-7ffb57df8efe	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Arte Maximum strength Numbing Cream	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	e612a256-3f44-46db-bb6a-e550c2216fdc	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Hello Sugar	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	5f30254d-a28f-443d-8729-5c5dde4a0217	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
TattooNumb	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	d9c4d664-54de-40c2-8836-72b60e6d9ac0	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
BeardedMoney	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	35ff688b-75c5-4780-b294-192af780d705	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
NeuroMed 7 Topical Pain Relief	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	f199f56b-d971-4cf8-834d-babb5c2ff81a	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
NeuroMed Topical Anesthetic 7	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals	8a2b6b76-6bcc-4f52-b037-e6cbc74f8377	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
NeuroMed Topical Anesthetic 7	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals	67b25c37-db32-4980-88b0-b07712345939	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidozall	LIDOCAINE HYDROCHLORIDE	V2 Pharma LLC	1eb2dfb2-3ad1-488b-aed9-17220e34a10c	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidozall Plus	LIDOCAINE HYDROCHLORIDE	V2 Pharma LLC	ba3cbb15-f4ed-443e-af43-a758481acb0b	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
TopCare Pain Relief Maximum Strength	LIDOCAINE HYDROCHLORIDE	TOPCO ASSOCIATES	b0ae3a7c-52d1-4923-bd50-6bb3749006c8	2025-11-11	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Eugia US LLC	5524cbfd-d6e6-42eb-aaa5-22495e0a86b6	2025-11-11	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
GuruNanda Pain Relief	LIDOCAINE HYDROCHLORIDE	GuruNanda, LLC.	3ab6a133-8dca-e14e-e063-6394a90a85e7	2025-11-10	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Xylocaine	LIDOCAINE HYDROCHLORIDE	Henry Schein, Inc.	ffc87dfb-0e26-4b42-80fd-3fb7690119e3	2025-11-07	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine hydrochloride	LIDOCAINE HYDROCHLORIDE	A-S Medication Solutions	e67dee40-b243-4d6b-bc6b-e52c6cb798b8	2025-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Henry Schein, Inc.	f73d4546-c9ac-4155-8492-552d6ce70c84	2025-10-31	Warnings, Adverse reactions	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