Lidocaine Hydrochloride and Hydrocortisone Acetate

Product NDC
13925-163
11-digit product format
139250163
Labeler code
13925
Product ID
13925-163_ccdbd16c-75e3-45f0-9e35-348ba321201b
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
Substance
HYDROCORTISONE ACETATE; LIDOCAINE HYDROCHLORIDE
Active strength
10; 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 and Hydrocortisone Acetate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE ACETATE10 mg/g
LIDOCAINE HYDROCHLORIDE30 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3X7931PO74, V13007Z41A
Rxcui1012229

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
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9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
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9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
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332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
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02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
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4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
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61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
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b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
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fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13925-163-07Lidocaine Hydrochloride and Hydrocortisone Acetate7 g in 1 TUBECREAM77
13925-163-20Lidocaine Hydrochloride and Hydrocortisone Acetate20 in 1 KITCREAM207

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13925-163-20EA - Each13925-1633dd130cf-d7e2-4a0d-ad64-7783067125d612012-07-24

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
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM [SETON PHARMACEUTICALS]1
CALCIUM ACETATEINACTIVE INGREDIENTY882YXF34XLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM [SETON PHARMACEUTICALS]1
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27ELIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM [SETON PHARMACEUTICALS]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM [SETON PHARMACEUTICALS]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLIDOCAINE 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
POLYCARBOPHILINACTIVE INGREDIENTW25LM17A4WLIDOCAINE 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 CITRATEINACTIVE INGREDIENT1Q73Q2JULRLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM [SETON PHARMACEUTICALS]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM [SETON PHARMACEUTICALS]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLIDOCAINE 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
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM [SETON PHARMACEUTICALS]1
UREAINACTIVE INGREDIENT8W8T17847WLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM [SETON PHARMACEUTICALS]1
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM [SETON PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13925-163LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM [SETON PHARMACEUTICALS]7Current NDC, Legacy NDC, 2 package rows20240131_951862db-3a73-4d25-9d5b-e4111833f43b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012229hydrocortisone acetate 1 % / lidocaine HCl 3 % Rectal CreamPSN951862db-3a73-4d25-9d5b-e4111833f43b7
1012229hydrocortisone acetate 10 MG/ML / lidocaine hydrochloride 30 MG/ML Rectal CreamSCD951862db-3a73-4d25-9d5b-e4111833f43b7
1012229hydrocortisone acetate 1 % / lidocaine hydrochloride 3 % Rectal CreamSY951862db-3a73-4d25-9d5b-e4111833f43b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13925-163-07139250163077 g in 1 TUBE7 gHistorical
13925-163-201392501632020 TUBE in 1 KIT (13925-163-20) / 7 g in 1 TUBE (13925-163-07) 20 tube2011-06-170000-00-00NoNoCurrent