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 212 of 222 · 4,434 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family WellnessGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, PETROLATUMFRONT PHARMACEUTICAL PLCeb1785f4-5876-443b-b175-9b59d65d1a482023-10-26WarningsExact identifier
unii: PDC6A3C0OX
CVS Health Hemorrhoidal CreamGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMFRONT PHARMACEUTICAL PLCcb448d78-553c-4e65-80c5-d4b31d7b36612023-10-26WarningsExact identifier
unii: PDC6A3C0OX
DG Health Cough Drops Cherry FlavorMENTHOLDollar General Corporationc7a603d8-72fb-9626-e053-2995a90a09ea2023-10-26WarningsExact identifier
unii: L7T10EIP3A
Freegells Cough Drops Menthol CherryMENTHOLRiclan S.A.8e471265-3594-451a-8921-f0db474abe852023-10-26WarningsExact identifier
unii: L7T10EIP3A
Freegells Cough Drops Menthol EucalyptusMENTHOLRiclan S.A.1141593a-f3ba-4adf-b332-f9fcb0b5a0132023-10-26WarningsExact identifier
unii: L7T10EIP3A
Freegells Cough Drops Menthol Honey LemonMENTHOLRiclan S.A.f6271e85-9ca2-41d3-9bff-a13670ac5b802023-10-26WarningsExact identifier
unii: L7T10EIP3A
Freegells Cough Drops Menthol StrawberryMENTHOLRiclan S.A.da2bbc92-7d96-4f3e-89e2-c2a9e3e4b4572023-10-26WarningsExact identifier
unii: L7T10EIP3A
Stopain ClinicalMENTHOL, UNSPECIFIED FORMTroy Manufacturing, Inc.b41091b4-0dc0-4a88-8ff6-11979b3d307a2023-10-25WarningsExact identifier
unii: L7T10EIP3A
Hemorrhoidal CreamGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMCardinal Health 110, LLC. dba Leader85a51d5c-679e-1959-e053-2a91aa0a76d52023-10-25WarningsExact identifier
unii: PDC6A3C0OX
Stopain ClinicalMENTHOLTroy Manufacturing, Inc.c8d4ae28-efc4-6a00-e053-2a95a90a40bf2023-10-25WarningsExact identifier
unii: L7T10EIP3A
Cryo10 Topical AnalgesicMENTHOLElement 26 LLCff1d2140-9302-918c-e053-6394a90acb9a2023-10-25WarningsExact identifier
unii: L7T10EIP3A
Stopain ClinicalMENTHOLTroy Manufacturing, Inc.3336cc35-e773-4705-84b5-61040604beef2023-10-25WarningsExact identifier
unii: L7T10EIP3A
XtraCare Ice Cold Topical Analgesic GelMENTHOLRejoice Internationald38f3099-d940-44d8-aa7f-404157c5e0e32023-10-24WarningsExact identifier
unii: L7T10EIP3A
TheraPlus PlusMENTHOLZhejiang Jingwei Pharmaceutical Co., Ltd.d4119f84-eb60-4134-b58e-de13d96011992023-10-24WarningsExact identifier
unii: L7T10EIP3A
Family WellnessGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, PETROLATUMZhejiang Jingwei Pharmaceutical Co., Ltd.fde9cd90-d63c-4058-b46e-511fecea36ec2023-10-24WarningsExact identifier
unii: PDC6A3C0OX
Isopropyl AlcoholISOPROPYL ALCOHOLJianerkang Medical Co., Ltd4bfea435-f40d-4976-8450-a699f7640c652023-10-23WarningsExact identifier
unii: ND2M416302
Sting ReliefBENZOCAINE, ISOPROPYL ALCOHOLJianerkang Medical Co., Ltd3a32398a-3f7e-4da0-bb1d-b3f369914b2a2023-10-23WarningsExact identifier
unii: ND2M416302
g and h Protect HandBENZALKONIUM CHLORIDEAccess Business Group LLC1103a4af-10d6-478f-85cd-c364569569e52023-10-23WarningsExact identifier
unii: F5UM2KM3W7
BZKBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltdd96c6ad2-c7e9-4079-9db2-59d108f284bb2023-10-23WarningsExact identifier
unii: F5UM2KM3W7
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltd1c7f9a00-6600-4b0d-af11-fa776b22e6782023-10-23WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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