FDA.reportPublic FDA data

NDC 0316-0201 - Dermasorb HC Complete Kit

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
0316-0201
Package NDCs from labels
0316-0201-01
Manufacturer
Crown Laboratories
Effective date
2019-09-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydrocortisone Lotion with Shampoo and Body Wash - Crown LaboratoriesCrown Laboratories2019-09-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONE ACETATEACTIVE INGREDIENT3X7931PO74DERMASORB HC COMPLETE KIT (HYDROCORTISONE LOTION WITH SHAMPOO AND BODY WASH) KIT [CROWN LABORATORIES]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJDERMASORB HC COMPLETE KIT (HYDROCORTISONE LOTION WITH SHAMPOO AND BODY WASH) KIT [CROWN LABORATORIES]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7DERMASORB HC COMPLETE KIT (HYDROCORTISONE LOTION WITH SHAMPOO AND BODY WASH) KIT [CROWN LABORATORIES]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302DERMASORB HC COMPLETE KIT (HYDROCORTISONE LOTION WITH SHAMPOO AND BODY WASH) KIT [CROWN LABORATORIES]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHDERMASORB HC COMPLETE KIT (HYDROCORTISONE LOTION WITH SHAMPOO AND BODY WASH) KIT [CROWN LABORATORIES]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DERMASORB HC COMPLETE KIT (HYDROCORTISONE LOTION WITH SHAMPOO AND BODY WASH) KIT [CROWN LABORATORIES]1
WATERINACTIVE INGREDIENT059QF0KO0RDERMASORB HC COMPLETE KIT (HYDROCORTISONE LOTION WITH SHAMPOO AND BODY WASH) KIT [CROWN LABORATORIES]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 192 of 222 · 4,434 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EcoCare 360BENZALKONIUMEcolab Inc.9f4571f3-7dbc-46ea-8a26-a0262469e67c2024-03-13WarningsExact identifier
unii: F5UM2KM3W7
Leader Cooling Pain Relief Topical AnalgesicMENTHOL, UNSPECIFIED FORMCardinal Health, 110 dba LEADERfd06d17f-4dff-42a9-a84f-904809ceb9812024-03-13WarningsExact identifier
unii: L7T10EIP3A
MENTHOL, CAMPHORMENTHOL, CAMPHOREROS GLOBALb3495c95-ba4b-9459-e053-2a95a90a710f2024-03-12WarningsExact identifier
unii: L7T10EIP3A
Pain Reliever CreamMENTHOL 10%, METHYL SALICYLATE 15%Trifecta Pharmaceuticals USA, LLC.130665d6-3de8-cb91-e063-6294a90a20832024-03-06WarningsExact identifier
unii: L7T10EIP3A
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLC1308ce91-2858-310a-e063-6394a90a68102024-03-06WarningsExact identifier
unii: F5UM2KM3W7
Dermachange Cold TherapyMENTHOLPrivate Label Beauty and Wellness12ef7dd8-3da3-9c87-e063-6394a90ac9242024-03-05WarningsExact identifier
unii: L7T10EIP3A
AnalgesicMENTHOLSafetec of America, Inc.b0f4010c-995f-40e1-aa40-92760e697a612024-03-02WarningsExact identifier
unii: L7T10EIP3A
Icy Hot Advanced ReliefCAMPHOR AND MENTHOLChattem, Inc.9979ff36-415b-44e4-bb10-6bf682cd00f92024-03-01WarningsExact identifier
unii: L7T10EIP3A
Amish Origins Pain Relieving Menthol 8%MENTHOLAmish Origins Management, LLC5051b650-18a4-481e-a8d7-d41d4ae51efd2024-02-29WarningsExact identifier
unii: L7T10EIP3A
Amish Origins Pain Relieving Menthol 8MENTHOLAmish Origins Management, LLCaaad56d5-6737-4edc-af0e-8e207695c0ec2024-02-29WarningsExact identifier
unii: L7T10EIP3A
Rite Aid Swimmers Ear DropsISOPROPYL ALCOHOLRite Aid12875b9d-3ae8-bd0c-e063-6294a90ab4ae2024-02-29WarningsExact identifier
unii: ND2M416302
Amish Origins Pain Relieving Menthol 8%MENTHOLAmish Origins Management, LLCb120404f-5a07-4182-bb50-d943418622da2024-02-29WarningsExact identifier
unii: L7T10EIP3A
LidoPro PatchLIDOCAINE, MENTHOL, AND METHYL SALICYLATEAdvanced Rx Pharmacy of Tennessee, LLC128d0ba9-bc9d-af16-e063-6394a90af5ef2024-02-29WarningsExact identifier
unii: L7T10EIP3A
Preparation H Rapid ReliefGLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC699310e8-1a93-40b4-a8f4-a765be4a0cb12024-02-29WarningsExact identifier
unii: PDC6A3C0OX
Leader Roll-On Cooling Pain Relief Topical AnalgesicMENTHOL, UNSPECIFIED FORMCardinal Health, 110 dba LEADERe86cba40-6b10-454d-98b3-6b547456eaad2024-02-29WarningsExact identifier
unii: L7T10EIP3A
XtraCare Foam Antibacterial Hand Wash Pink Cherry BlossomBENZALKONIUM CHLORIDERejoice Internationala9a1467c-abcc-4ccb-88f6-4302796097882024-02-28WarningsExact identifier
unii: F5UM2KM3W7
XtraCare Foam Antibacterial Hand Wash Refill Pink Cherry BlossomBENZALKONIUM CHLORIDERejoice International9fa9d955-7167-4a0a-935b-2a600f439eb02024-02-28WarningsExact identifier
unii: F5UM2KM3W7
XtraCare Foam Antibacterial Hand Wash Refill Vanilla Passion FlowerBENZALKONIUM CHLORIDERejoice International157a14bf-f46e-49f8-96f4-a6c472eb5cb82024-02-28WarningsExact identifier
unii: F5UM2KM3W7
XtraCare Foaming Hand SanitizerBENZALKONIUM CHLORIDERejoice International3082cbbb-a0ed-45eb-a116-ad1c65357dd12024-02-28WarningsExact identifier
unii: F5UM2KM3W7
XtraCare Foam Antibacterial Hand Wash Refill Wild Berry BlastBENZALKONIUM CHLORIDERejoice International45b3ca49-edb4-4840-b857-d24045494a3a2024-02-28WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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