FDA.reportPublic FDA data

NDC 67857-804-30 - Cloderm

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
67857-804
Requested NDC
67857-804-30
Package NDCs from labels
67857-804-45, 67857-804-51, 67857-804-90, 67857-804-23, 67857-804-48, 67857-804-30
Manufacturer
Promius Pharma, LLC | DPT Laboratories, LTD
Effective date
2019-04-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cloderm - Promius Pharma, LLC | DPT Laboratories, LTDPromius Pharma, LLC | DPT Laboratories, LTD2019-04-22HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
67857-804-45Cloderm ® Cream, 0.1% (clocortolone pivalate)
67857-804-48Cloderm ® Cream, 0.1% (clocortolone pivalate)
67857-804-51Cloderm ® Cream, 0.1% (clocortolone pivalate)
67857-804-90Cloderm ® Cream, 0.1% (clocortolone pivalate)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67857-804-23Cloderm2 g in 1 TUBECREAM27
67857-804-45Cloderm45 g in 1 TUBECREAM457
67857-804-48Cloderm10 in 1 CARTONCREAM107
67857-804-51Cloderm75 g in 1 BOTTLE, PUMPCREAM757
67857-804-90Cloderm90 g in 1 TUBECREAM907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67857-804CLODERM (CLOCORTOLONE PIVALATE) CREAM [PROMIUS PHARMA, LLC]7Legacy NDC, 5 package rows20190918_4abc01f2-03d4-43d5-a085-f452443cfca2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67857-804-30GM - Gram67857-8042417c3bd-1896-451d-b35b-91225ecfc93112012-07-24
67857-804-45GM - Gram67857-8049c11f33b-523a-40b3-8442-102e84d2c2c712012-07-24
67857-804-51GM - Gram67857-8041b2acf2f-6d5b-4334-8f48-c066fe95d4c412013-02-13
67857-804-90GM - Gram67857-804302b5505-1d35-4f92-9aea-2203c1f5ee4212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
clocortolone pivalateACTIVE INGREDIENTQBL8IZH14XCLODERM (CLOCORTOLONE PIVALATE) CREAM [PROMIUS PHARMA, LLC]3
clocortoloneACTIVE MOIETYN8ZUB7XE0HCLODERM (CLOCORTOLONE PIVALATE) CREAM [PROMIUS PHARMA, LLC]3
CARBOMER HOMOPOLYMER TYPE BINACTIVE INGREDIENTHHT01ZNK31CLODERM (CLOCORTOLONE PIVALATE) CREAM [PROMIUS PHARMA, LLC]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCLODERM (CLOCORTOLONE PIVALATE) CREAM [PROMIUS PHARMA, LLC]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCLODERM (CLOCORTOLONE PIVALATE) CREAM [PROMIUS PHARMA, LLC]3
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPCLODERM (CLOCORTOLONE PIVALATE) CREAM [PROMIUS PHARMA, LLC]3
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UCLODERM (CLOCORTOLONE PIVALATE) CREAM [PROMIUS PHARMA, LLC]3
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9ICLODERM (CLOCORTOLONE PIVALATE) CREAM [PROMIUS PHARMA, LLC]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCLODERM (CLOCORTOLONE PIVALATE) CREAM [PROMIUS PHARMA, LLC]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICLODERM (CLOCORTOLONE PIVALATE) CREAM [PROMIUS PHARMA, LLC]3
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YCLODERM (CLOCORTOLONE PIVALATE) CREAM [PROMIUS PHARMA, LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RCLODERM (CLOCORTOLONE PIVALATE) CREAM [PROMIUS PHARMA, LLC]3

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 38 · 743 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: 4T6H12BN9U
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
PURE PETROLATUMPETROLATUMVASA COSMETICS PRIVATE LIMITED5a57b197-3e18-b3ab-e063-6394a90aed822026-08-31WarningsExact identifier
unii: 4T6H12BN9U
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
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Mineral Oil/White PetrolatumMINERAL OIL/WHITE PETROLATUMYYBA CORP5967ef02-6770-bfd7-e063-6294a90a79042026-08-19WarningsExact identifier
unii: T5L8T28FGP
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Mineral Oil/White PetrolatumMINERAL OIL/WHITE PETROLATUMYYBA CORP5905b300-6f1f-a61f-e063-6394a90a11232026-08-14WarningsExact identifier
unii: T5L8T28FGP
Mineral oilMINERAL OILEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)92f2147d-b52d-4282-b217-28f6095dca0e2026-08-12WarningsExact identifier
unii: T5L8T28FGP
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Petroleum Jelly, Lil Drug StorePETROLATUM JELLYLil' Drug Store Products, Inc.5862af40-97e2-d792-e063-6394a90a0f1a2026-08-06WarningsExact identifier
unii: 4T6H12BN9U
Mineral OilMINERAL OILOld East Main Co.4bae831d-caba-40c9-bdb5-2611eac35dd52026-08-05Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Dealmed Vitamins A and DPETROLATUMDealmed Medical Supplies, LLC.84afe4ae-f9e8-406f-9fbe-f413975f86eb2026-08-05WarningsExact identifier
unii: 4T6H12BN9U
Petroleum JellyPETROLATUMWalgreens1bb250ee-c4b7-4e9f-9d13-46ef9df4a9f52026-08-04WarningsExact identifier
unii: 4T6H12BN9U
PROCURE VITAMIN A AND D Skin ProtectantPETROLATUMTWIN MED, LLCbbbca68e-1b65-49b1-a5fa-ed4da55d05e32026-08-03WarningsExact identifier
unii: 4T6H12BN9U
HEMORRHOIDALCREAMPROCUREPHENYLEPHRINE HCL, PETROLATUM, MINERAL OILTWIN MED, LLCe9c44756-1c98-41be-e053-2995a90a35b42026-08-03WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
procurePETROLATUMTWIN MED, LLC32520d8f-91ee-47a1-9129-bf0746791f4b2026-08-03WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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