LIDOCAINE HYDROCHLORIDE, HYDROCORTISONE ACETATE

Product NDC
24470-964
11-digit product format
244700964
Labeler code
24470
Product ID
24470-964_2251d01e-5602-0d0b-e063-6394a90aefd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE, HYDROCORTISONE ACETATE
Dosage form
GEL
Route
RECTAL
Labeler
Cintex Services, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-09-11
Substance
HYDROCORTISONE ACETATE; LIDOCAINE HYDROCHLORIDE
Active strength
25; 30 mg/g; mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [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
LIDOCAINE HYDROCHLORIDE, HYDROCORTISONE ACETATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE ACETATE25 mg/g
LIDOCAINE HYDROCHLORIDE30 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3X7931PO74, V13007Z41A
Rxcui1012223

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
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36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
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da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24470-964-01LIDOCAINE HYDROCHLORIDE, HYDROCORTISONE ACETATE7 g in 1 TUBEGEL72
24470-964-20LIDOCAINE HYDROCHLORIDE, HYDROCORTISONE ACETATE20 in 1 KITGEL202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24470-964-20EA - Each24470-9648202a0fb-1009-4b94-844b-010e82d2629c12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24470-964LIDOCAINE HYDROCHLORIDE, HYDROCORTISONE ACETATE GEL [CINTEX SERVICES, LLC]2Current NDC, 2 package rows20240919_21dcb757-1f7c-a4ca-e063-6394a90a456d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012223lidocaine HCl 3 % / hydrocortisone acetate 2.5 % Rectal GelPSN21dcb757-1f7c-a4ca-e063-6394a90a456d2
1012223hydrocortisone acetate 0.025 MG/MG / lidocaine hydrochloride 0.03 MG/MG Rectal GelSCD21dcb757-1f7c-a4ca-e063-6394a90a456d2
1012223hydrocortisone acetate 2.5 % / lidocaine HCl 3 % Rectal GelSY21dcb757-1f7c-a4ca-e063-6394a90a456d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
24470-964-01244700964017 g in 1 TUBE7 gHistorical
24470-964-202447009642020 TUBE in 1 KIT (24470-964-20) / 7 g in 1 TUBE (24470-964-01) 20 tube2024-09-11NoNoHistorical