GLYDO- lidocaine hydrochloride jelly

Product NDC
51662-1652
11-digit product format
516621652
Labeler code
51662
Product ID
51662-1652_3364b25d-bf31-c028-e063-6394a90a8008
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GLYDO- lidocaine hydrochloride jelly
Dosage form
JELLY
Route
TOPICAL
Labeler
HF Acquisition Co. LLC, DBA HealthFirst
Application
ANDA201094
Marketing category
ANDA
Marketing start
2014-09-15
Substance
LIDOCAINE HYDROCHLORIDE ANHYDROUS
Active strength
20 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201094-001GLYDOLIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATRS2014-04-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201094-001AT

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A201094-001GLYDO2%JELLY / TOPICALATRS2014-04-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201094-001GLYDO2%JELLY / TOPICALATRS2014-04-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A201094-001GLYDO2%JELLY / TOPICALATRS2014-04-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201094-001GLYDO2%JELLY / TOPICALATRS2014-04-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201094-001GLYDO2%JELLY / TOPICALATRS2014-04-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201094-001GLYDO2%JELLY / TOPICALATRS2014-04-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201094-001GLYDO2%JELLY / TOPICALATRS2014-04-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201094-001GLYDO2%JELLY / TOPICALATRS2014-04-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201094-001GLYDO2%JELLY / TOPICALATRS2014-04-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201094-001GLYDO2%JELLY / TOPICALATRS2014-04-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201094-001GLYDO2%JELLY / TOPICALATRS2014-04-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201094-001GLYDO2%JELLY / TOPICALATRS2014-04-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201094-001GLYDO2%JELLY / TOPICALATRS2014-04-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201094-001GLYDO2%JELLY / TOPICALATRS2014-04-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201094-001GLYDO2%JELLY / TOPICALAT2014-04-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201094-001GLYDO2%JELLY / TOPICALAT2014-04-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201094-001GLYDO2%JELLY / TOPICALAT2014-04-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201094-001GLYDO2%JELLY / TOPICALAT2014-04-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201094-001GLYDO2%JELLY / TOPICALAT2014-04-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201094-001GLYDO2%JELLY / TOPICALAT2014-04-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201094-001GLYDO2%JELLY / TOPICALAT2014-04-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A201094-001GLYDO2%JELLY / TOPICALAT2014-04-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201094-001GLYDO2%JELLY / TOPICALAT2014-04-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201094-001GLYDO2%JELLY / TOPICALAT2014-04-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201094-001GLYDO2%JELLY / TOPICALAT2014-04-283f01610625f2…
2019-09-15 20:21 UTC2019-09A201094-001GLYDO2%JELLY / TOPICALAT2014-04-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A201094-001GLYDO2%JELLY / TOPICALAT2014-04-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201094-001GLYDO2%JELLY / TOPICALATRS2014-04-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201094-001GLYDO2%JELLY / TOPICALATRS2014-04-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201094-001GLYDO2%JELLY / TOPICALATRS2014-04-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201094-001GLYDO2%JELLY / TOPICALATRS2014-04-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201094-001GLYDO2%JELLY / TOPICALATRS2014-04-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201094-001GLYDO2%JELLY / TOPICALATRS2014-04-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201094-001GLYDO2%JELLY / TOPICALATRS2014-04-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A201094-001GLYDO2%JELLY / TOPICALAT2014-04-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A201094-001GLYDO2%JELLY / TOPICALAT2014-04-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201094-001GLYDO2%JELLY / TOPICALAT2014-04-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201094-001GLYDO2%JELLY / TOPICALAT2014-04-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201094-001GLYDO2%JELLY / TOPICALAT2014-04-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A201094-001GLYDO2%JELLY / TOPICALAT2014-04-28cb3db0bc1861…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A201094-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201094-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201094-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201094-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201094-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201094-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201094-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201094-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201094-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201094-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201094-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201094-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201094-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201094-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201094-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201094-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201094-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201094-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201094-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201094-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201094-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A201094-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201094-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201094-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201094-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A201094-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A201094-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201094-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201094-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201094-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201094-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201094-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201094-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201094-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A201094-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A201094-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201094-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201094-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201094-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A201094-001AT1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
GLYDO- lidocaine hydrochloride jelly
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
EC2CNF7XFPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1011852Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3364b25d-bf30-c028-e063-6394a90a8008Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
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
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1652-1GLYDO- lidocaine hydrochloride jelly6 mL in 1 SYRINGEJELLY61
51662-1652-1GLYDO- lidocaine hydrochloride jelly1 in 1 SYRINGEJELLY11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1652GLYDO- LIDOCAINE HYDROCHLORIDE JELLY JELLY [HF ACQUISITION CO. LLC, DBA HEALTHFIRST]1Current NDC, 2 package rows20250424_3364b25d-bf30-c028-e063-6394a90a8008.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
glydoLIDOCAINE HYDROCHLORIDESagent Pharmaceuticals65760723-75cd-472c-96e1-7d05f95b46862026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201094
application number: ANDA201094
GLYDO- lidocaine hydrochloride jellyGLYDO- LIDOCAINE HYDROCHLORIDE JELLYHF Acquisition Co. LLC, DBA HealthFirst3364b25d-bf30-c028-e063-6394a90a80082025-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201094
application number: ANDA201094
ndc (product): 51662-1652

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011852lidocaine HCl 2 % Topical GelPSN3364b25d-bf30-c028-e063-6394a90a80081
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCD3364b25d-bf30-c028-e063-6394a90a80081
1011852lidocaine hydrochloride 2 % Topical JellySY3364b25d-bf30-c028-e063-6394a90a80081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51662-1652-1516621652011 SYRINGE in 1 SYRINGE (51662-1652-1) / 6 mL in 1 SYRINGE1 syringe2014-09-15NoNoCurrent