FDA.reportPublic FDA data

NDC 13925-157-07 - Lidocaine Hydrochloride and Hydrocortisone Acetate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
13925-157
Requested NDC
13925-157-07
Package NDCs from labels
13925-157-07, 13925-157-14
Manufacturer
Seton Pharmaceuticals | Medical Products Laboratories, Inc.
Effective date
2022-02-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lidocaine 3% - Hydrocortisone 0.5% Cream KitSeton Pharmaceuticals | Medical Products Laboratories, Inc.2022-02-08HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

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

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 2 of 86 · 1,713 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Jack Black Intensive Therapy Lip Balm Mango Chili LimeAVOBENZONE, OCTINOXATE LIP BALM SUNSCREENJack Black, LLC51349d57-b14d-4798-8d68-03fbe3713d1e2026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Intense Thearpy Lip Balm SPF25, Lemon and Shea ButterLIP BALM SUNSCREENJack Black, LLC518cb17a-fdaa-4a60-93fc-708305366eb82026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Lavender Lip Balm 0.25ozLIP BALM SUNSCREENJack Black, L.L.C.e8c6a6d9-1093-41f1-87d5-faf8583d43192026-09-08WarningsExact identifier
unii: 4T6H12BN9U
American Safety First AidLIDOCAINE HCLOrazen Incea2f776b-dfd0-6ce4-e053-2995a90af0092026-09-07WarningsExact identifier
unii: V13007Z41A
MEDI-FIRST Topical AnalgesicLIDOCAINE HCIUltra Distributors Incb6f288f7-9ae3-215e-e053-2a95a90aedf62026-09-07WarningsExact identifier
unii: V13007Z41A
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf508434f-5948-7134-e053-2a95a90a03d72026-09-05WarningsExact identifier
unii: V13007Z41A
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf522fb0b-3d86-b228-e053-2a95a90a55e92026-09-05WarningsExact identifier
unii: V13007Z41A
Nerve Guard Nerve ReliefLIDOCAINE HYDROCHLORIDE, MENTHOL,MAGNESIUM CHLORIDEMicelle Laboratories, Incorporated6b78f40f-2a7f-4c49-96af-1a95acbf430f2026-09-04WarningsExact identifier
unii: V13007Z41A
Calcium AcetateCALCIUM ACETATEAmerican Health Packaging2072d9f4-abb1-4699-bde5-6041dd79cad52026-09-04Warnings, Adverse reactionsExact identifier
unii: Y882YXF34X
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: 4T6H12BN9U
Lidocaine ViscousLIDOCAINE HYDROCHLORIDEREMEDYREPACK INC.6f8d20d2-6a91-4a5b-bfe8-f1baada384422026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
calcium acetateCALCIUM ACETATEREMEDYREPACK INC.89a2ee04-1024-4a81-ba0d-a6655d5298272026-09-03Warnings, Adverse reactionsExact identifier
unii: Y882YXF34X
Petroleum Skin ProtectantWHITE PETROLATUMYour Military Exchanges1a0aed14-8606-4676-b4b5-23dd415d43ac2026-09-02Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
OilMINERAL OILAtlantic Biologicals Corp.5a82197b-281d-76c0-e063-6294a90a57462026-09-02Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
HUSTLE BUTTER NUMBINGLIDOCAINE HCL, BENZALKONIUM CHLORIDEH.B.D. DIST. INC.5b4d0390-dac6-4a71-9fdc-5c31543e7c5a2026-09-02WarningsExact identifier
unii: V13007Z41A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma9920daef-b156-4a14-b641-f714191ffb5c2026-09-02Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
PURE PETROLATUMPETROLATUMVASA COSMETICS PRIVATE LIMITED5a57b197-3e18-b3ab-e063-6394a90aed822026-08-31WarningsExact identifier
unii: 4T6H12BN9U
Hydrocortisone AcetateHYDROCORTISONE ACETATEPreferred Pharmaceuticals, Inc.247bb729-f0b6-4325-a9f8-4b46d5cda3002026-08-28Adverse reactionsExact identifier
unii: 3X7931PO74
HYDROPHORHYDROPHORAkron Pharma Inc.e6099df7-d418-479a-9d2e-ced523585aed2026-08-28WarningsExact identifier
unii: 4T6H12BN9U
Mineral OilMINERAL OILYour Military Exchanges6025dce6-02e8-418c-a248-0b5c33ff60672026-08-28Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP

Reported adverse events (FAERS/openFDA)#

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