FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
UniiEC2CNF7XFP
Rxcui1011852

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

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 syringe2014-09-15NoNoHistorical