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 57 of 233 · 4,642 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aquarrelle Antibacterial Wipes 40BENZALKONIUM CHLORIDEKimberly-Clark De Mexico, S.A.B.deC.V.3584680e-71b0-23b6-e063-6294a90a69982026-02-05WarningsExact identifier
unii: F5UM2KM3W7
Aquarrelle Antibacterial Wipes 20BENZALKONIUM CHLORIDEKimberly-Clark De Mexico, S.A.B.deC.V.35865d33-a99f-1b37-e063-6394a90a00d22026-02-05WarningsExact identifier
unii: F5UM2KM3W7
ForPro Premium Sterile Antiseptic Isopropyl Alcohol PadsISOPROPYL ALCOHOLTng workdwide6cc2ccae-b288-473e-a736-0974c96dbb892026-02-05WarningsExact identifier
unii: ND2M416302
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLPharmacy Value Alliance, LLCd836c3e2-3b69-41f3-b166-21270550e8ab2026-02-05Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Benzalkonium chlorideBENZALKONIUM CHLORIDEPharmacy Value Alliance, LLC5f9521f2-53f2-4d7e-9116-36e94e2d06952026-02-05Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Isopropyl AlcoholISOPROPYL ALCOHOLPharmacy Value Alliance, LLC528011d7-8c6d-4940-bee1-52b39acef40d2026-02-05Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLPublix Super Markets, Inc.81b1d5bb-f813-4f79-9559-2494db33ad3c2026-02-05Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Aloe Vera GelLIDOCAINE HCL, MENTHOLPublix Super Markets, Inc.fe442f1e-7045-481a-a501-d629bf568dfb2026-02-05Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Isopropyl AlcoholISOPROPYL ALCOHOLPublix Super Markets, Inc.14aecc7b-c68a-4cb9-863f-475e204f66a52026-02-05WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLPublix Super Markets, Inc.b3b5324b-ee2c-4f87-9bb9-81d3d85f73ee2026-02-05WarningsExact identifier
unii: ND2M416302
Care Lix Pain ReliefSALICYLIC ACIDACQUIRED B SCALE LLC65dffffd-ede1-45e2-aa91-bdd5df2df6a62026-02-05WarningsExact identifier
unii: L7T10EIP3A
2.5% Menthol PAIN RELIEFMENTHOLNantong Health & Beyond Hygienic Products Inc.8075ba60-772c-4d1a-8584-722bb3e539be2026-02-05WarningsExact identifier
unii: L7T10EIP3A
4% Menthol PAIN RELIEFMENTHOLNantong Health & Beyond Hygienic Products Inc.51ce716e-b9f3-4e64-8c8e-17520d40f1922026-02-05WarningsExact identifier
unii: L7T10EIP3A
4% MENTHOL COLD THERAPYMENTHOLNantong Health & Beyond Hygienic Products Inc.7acc7282-ef4f-41ec-b51d-a88dfed79bd72026-02-05WarningsExact identifier
unii: L7T10EIP3A
Isopropyl alcohol 50 percentISOPROPYL ALCOHOLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)b1b52183-3296-48b2-b3d3-821c141b0bea2026-02-05WarningsExact identifier
unii: ND2M416302
Isopropyl alcohol 50 percentISOPROPYL ALCOHOLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)ee67fb96-fa2c-4542-8fdb-f2ccd885ee532026-02-05WarningsExact identifier
unii: ND2M416302
Zehn Antiseptic Sanitizing WipesBENZALKONIUM CHLORIDEZehn Wipes1c7bfc17-e552-1f51-e063-6394a90a24ac2026-02-04WarningsExact identifier
unii: F5UM2KM3W7
ANTIBACTERIALBENZALKONIUM CHLORIDETopco Associates LLC463f3a53-921a-65cb-e063-6394a90ab4f22026-02-04Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLDiscount Drug Mart2075ed67-bb89-41bc-98bc-a6ab2262bdc72026-02-04Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLDiscount Drug Mart53526652-49ac-411b-8906-74f2ad4b64762026-02-04Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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