Zingo

Product NDC
61388-001
11-digit product format
613880001
Labeler code
61388
Product ID
61388-001_8a718360-be4c-4dea-b9bc-e9e4beff29b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lidocaine hydrochloride monohydrate
Dosage form
POWDER
Route
INTRADERMAL
Labeler
Powder Pharmaceuticals Inc.
Application
NDA022114
Marketing category
NDA
Marketing start
2015-01-05
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
1 mg/1
Pharmacologic classes
Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61388-001IInactivated by FDA2026-10-12
excluded packagepackage61388-00161388-001-48IInactivated by FDA2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61388-001-48d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61388-001-48f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61388-001-482ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61388-001-48a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61388-001-48cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61388-001-48cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61388-001-48302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61388-001-48ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61388-001-480efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61388-001-48ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61388-001-48367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61388-001-48557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61388-001-488af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61388-001-48834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61388-001-481332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage61388-001-48fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage61388-001-4886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage61388-001-48bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage61388-001-488dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage61388-001-48e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage61388-001-489bebd1f3094a…5416666fcb17…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022114-001ZINGOLIDOCAINE HYDROCHLORIDE0.5MGSYSTEM / INTRADERMAL2007-08-16

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022114-00185406652029-10-22U-14382013-10-09
N022114-00193583382035-04-27U-18702016-07-06
N022114-00193706222035-09-28U-18702016-07-06

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-1684e616aacf4f…
2026-08-18 06:07:402026-07N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-1687673890dc5c…
2021-03-12 10:30 UTC2021-03N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-163f01610625f2…
2019-09-15 20:21 UTC2019-09N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16b00525d2431f…
2019-07-19 19:46 UTC2019-07N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-163f0d92c62455…
2023-05-13 08:27 UTC2023-05N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16053a50430f4f…
2023-01-26 05:58 UTC2023-01N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16f41ea6bd6efb…

Observed Orange Book patent history#

Patent history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N022114-00185406652029-10-22U-14382013-10-0984e616aacf4f…
2026-09-14 22:38:342026-08N022114-00193583382035-04-27U-18702016-07-0684e616aacf4f…
2026-09-14 22:38:342026-08N022114-00193706222035-09-28U-18702016-07-0684e616aacf4f…
2026-08-18 06:07:402026-07N022114-00185406652029-10-22U-14382013-10-09caaa826d4ba7…
2026-08-18 06:07:402026-07N022114-00193583382035-04-27U-18702016-07-06caaa826d4ba7…
2026-08-18 06:07:402026-07N022114-00193706222035-09-28U-18702016-07-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022114-00185406652029-10-22U-14382013-10-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022114-00193583382035-04-27U-18702016-07-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022114-00193706222035-09-28U-18702016-07-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022114-00185406652029-10-22U-14382013-10-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022114-00193583382035-04-27U-18702016-07-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022114-00193706222035-09-28U-18702016-07-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08N022114-00185406652029-10-22U-14382013-10-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022114-00193583382035-04-27U-18702016-07-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022114-00193706222035-09-28U-18702016-07-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022114-00185406652029-10-22U-14382013-10-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022114-00193583382035-04-27U-18702016-07-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022114-00193706222035-09-28U-18702016-07-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022114-00185406652029-10-22U-14382013-10-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022114-00193583382035-04-27U-18702016-07-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022114-00193706222035-09-28U-18702016-07-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022114-00185406652029-10-22U-14382013-10-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022114-00193583382035-04-27U-18702016-07-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022114-00193706222035-09-28U-18702016-07-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022114-00185406652029-10-22U-14382013-10-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022114-00193583382035-04-27U-18702016-07-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022114-00193706222035-09-28U-18702016-07-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022114-00185406652029-10-22U-14382013-10-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022114-00193583382035-04-27U-18702016-07-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022114-00193706222035-09-28U-18702016-07-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022114-00185406652029-10-22U-14382013-10-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022114-00193583382035-04-27U-18702016-07-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022114-00193706222035-09-28U-18702016-07-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022114-00185406652029-10-22U-14382013-10-09d06236e962d9…
2024-10-29 15:01 UTC2024-10N022114-00193583382035-04-27U-18702016-07-06d06236e962d9…
2024-10-29 15:01 UTC2024-10N022114-00193706222035-09-28U-18702016-07-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022114-00185406652029-10-22U-14382013-10-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022114-00193583382035-04-27U-18702016-07-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022114-00193706222035-09-28U-18702016-07-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022114-00185406652029-10-22U-14382013-10-09301d65b070ca…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61388-001-48Zingo12 in 1 CARTONPOWDER122
61388-001-48Zingo1 in 1 POUCHPOWDER12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41AZINGO (LIDOCAINE HYDROCHLORIDE MONOHYDRATE) POWDER [POWDER PHARMACEUTICALS INC.]2
LIDOCAINEACTIVE MOIETY98PI200987ZINGO (LIDOCAINE HYDROCHLORIDE MONOHYDRATE) POWDER [POWDER PHARMACEUTICALS INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61388-001ZINGO (LIDOCAINE HYDROCHLORIDE MONOHYDRATE) POWDER [POWDER PHARMACEUTICALS INC.]2Legacy NDC, 2 package rows20150108_ea5416d6-5988-413b-8682-6835b359eb78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011707lidocaine HCl 0.5 MG Jet InjectorPSNea5416d6-5988-413b-8682-6835b359eb782
1011709ZiNGO 0.5 MG Jet InjectorPSNea5416d6-5988-413b-8682-6835b359eb782
1011709lidocaine hydrochloride 0.5 MG Jet Injector [Zingo]SBDea5416d6-5988-413b-8682-6835b359eb782
1011707lidocaine hydrochloride 0.5 MG Jet InjectorSCDea5416d6-5988-413b-8682-6835b359eb782
1011709Zingo 0.5 MG Jet InjectorSYea5416d6-5988-413b-8682-6835b359eb782

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61388-001-486138800014812 in 1 CARTONHistorical