FDA.reportPublic FDA data

Lidocaine Hydrochloride and Hydrocortisone Acetate

Product NDC
13925-157
Requested package NDC
13925-157-14
11-digit product format
139250157
Labeler code
13925
Product ID
13925-157_4341dca4-a395-49c8-8e92-bc316f480ea4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride and Hydrocortisone Acetate
Dosage form
CREAM
Route
RECTAL
Labeler
Seton Pharmaceuticals
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-06-17
Marketing end
0000-00-00
Substance
HYDROCORTISONE ACETATE; LIDOCAINE HYDROCHLORIDE
Active strength
5 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
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage13925-15713925-157-14DDiscontinued by firm2026-10-05

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13925-157-142022-02-08C16284748780-1d6a99b39-b8dd-a426-e053-dadaa90af4c2Lidocaine 3% - Hydrocortisone 0.5% Cream Kit
13925-157-142022-01-28C16284748780-1d6a99b39-b8dd-a426-e053-dadaa90af4c2Lidocaine 3% - Hydrocortisone 0.5% Cream Kit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13925-157-07GM - Gram13925-1579b76a63c-caa0-4497-a99b-66fde0c31cac12013-02-13
13925-157-14GM - Gram13925-157be904bb7-7624-415c-8843-e54e255ddc4912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONE ACETATEACTIVE INGREDIENT3X7931PO74LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM [SETON PHARMACEUTICALS]1
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ALIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM [SETON PHARMACEUTICALS]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM [SETON PHARMACEUTICALS]1
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM [SETON PHARMACEUTICALS]1
ALUMINUM SULFATEINACTIVE INGREDIENT34S289N54ELIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM [SETON PHARMACEUTICALS]1
CALCIUM ACETATEINACTIVE INGREDIENTY882YXF34XLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM [SETON PHARMACEUTICALS]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM [SETON PHARMACEUTICALS]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM [SETON PHARMACEUTICALS]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM [SETON PHARMACEUTICALS]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM [SETON PHARMACEUTICALS]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9ULIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM [SETON PHARMACEUTICALS]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM [SETON PHARMACEUTICALS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM [SETON PHARMACEUTICALS]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM [SETON PHARMACEUTICALS]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM [SETON PHARMACEUTICALS]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM [SETON PHARMACEUTICALS]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM [SETON PHARMACEUTICALS]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM [SETON PHARMACEUTICALS]1
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM [SETON PHARMACEUTICALS]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13925-157-141392501571414 TUBE in 1 KIT (13925-157-14) > 7 g in 1 TUBE (13925-157-07) 14 tube2011-06-170000-00-00NoNoCurrent