FDA.reportPublic FDA data

NDC 58980-780-50 - VENELEX

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
58980-780
Requested NDC
58980-780-50
Package NDCs from labels
58980-780-11, 58980-780-21, 58980-780-50
Manufacturer
STRATUS PHARMACEUTICALS INC | TARMAC PRODUCTS INC
Effective date
2021-04-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
VENELEX - STRATUS PHARMACEUTICALS INC | TARMAC PRODUCTS INCSTRATUS PHARMACEUTICALS INC | TARMAC PRODUCTS INC2021-04-01MEDICAL DEVICE

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58980-780-212021-12-08C16284748780-1956f9ecf-cace-621f-e053-dbdaa90a74adVENELEX™ OINTMENT
58980-780-212019-10-21C16284748780-1956f9ecf-cace-621f-e053-dbdaa90a74adVENELEX™ OINTMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58980-780-11VENELEX1 in 1 BOX16
58980-780-11VENELEX30 g in 1 TUBE306
58980-780-21VENELEX60 g in 1 TUBE606
58980-780-21VENELEX1 in 1 BOX16
58980-780-50VENELEX1 in 1 BOX, UNIT-DOSE16
58980-780-50VENELEX5 g in 1 PACKET56

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58980-780VENELEX () [STRATUS PHARMACEUTICALS INC]6Legacy NDC, 6 package rows20231205_13291e03-6f75-403b-afc4-c44a10ca0083.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58980-780-11GM - Gram58980-78069f789b5-56dd-4be3-8ba0-789dedb95f8c12015-08-04
58980-780-21GM - Gram58980-7802a15939d-9d50-4180-b649-62331a37475912012-07-24
58980-780-50GM - Gram58980-7809626c6ef-7acb-4086-870d-4d8e698cbe3412015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Balsam PeruACTIVE INGREDIENT8P5F881OCYVENELEX () [STRATUS PHARMACEUTICALS]2
Castor OilACTIVE INGREDIENTD5340Y2I9GVENELEX () [STRATUS PHARMACEUTICALS]2
Balsam PeruACTIVE MOIETY8P5F881OCYVENELEX () [STRATUS PHARMACEUTICALS]2
Castor OilACTIVE MOIETYD5340Y2I9GVENELEX () [STRATUS PHARMACEUTICALS]2
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE4VENELEX () [STRATUS PHARMACEUTICALS]2
PetrolatumINACTIVE INGREDIENT4T6H12BN9UVENELEX () [STRATUS PHARMACEUTICALS]2

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 29 · 563 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
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
RegenarXCASTORTejeda Enterprises Incorporated55f75e79-da6a-d91b-e063-6294a90afee12026-08-15WarningsExact identifier
unii: D5340Y2I9G
BM BM164 DROPSARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUMBM Private Limited5902770f-eb01-d099-e063-6394a90ad3eb2026-08-14WarningsExact identifier
unii: 8P5F881OCY
BM BM165 DROPSANGELICA ATRO, BALSAM PER, BARIUM MUR, GRINDELIA, KALI BICH, KALI IOD, KALI MUR, SILPHIUM LACBM Private Limited590301da-8f93-3b1e-e063-6394a90a1e722026-08-14WarningsExact identifier
unii: 8P5F881OCY
Petroleum Jelly, Lil Drug StorePETROLATUM JELLYLil' Drug Store Products, Inc.5862af40-97e2-d792-e063-6394a90a0f1a2026-08-06WarningsExact identifier
unii: 4T6H12BN9U
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
Nail Treatment Repairing LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.57b8b3e5-88be-3a91-e063-6294a90a05be2026-08-03WarningsExact identifier
unii: D5340Y2I9G
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
procurePETROLATUMTWIN MED, LLC32520d8f-91ee-47a1-9129-bf0746791f4b2026-08-03WarningsExact identifier
unii: 4T6H12BN9U
ProCure HydroShieldPETROLATUM 44.28%Twin Med LLC3ab7bfb2-bbcf-0822-e063-6294a90af0842026-08-03WarningsExact identifier
unii: 4T6H12BN9U
OKeeffes Lip Repair SEAL and HEALPETROLATUMThe Gorilla Glue Company/O'Keeffe's Company55f66f54-da39-76c7-e063-6394a90aeda92026-07-27WarningsExact identifier
unii: 4T6H12BN9U
PrevaDRM Vitamin RepairSKIN PROTECTANTSion Brands LLC579e4639-a742-1901-e063-6294a90a2d452026-07-27WarningsExact identifier
unii: 4T6H12BN9U
Baby Vitamin A and DLANOLIN 15.5%, PETROLATUM 53.4%Walgreen Company25a125ea-6f9f-310c-e063-6394a90acef22026-07-22WarningsExact identifier
unii: 4T6H12BN9U
First Aid A and DLANOLIN 15.5%, PETROLATUM 53.4%Walgreen Company25a319d0-d39a-5ff0-e063-6394a90a671d2026-07-22WarningsExact identifier
unii: 4T6H12BN9U
CAREALL Vitamin A and DPETROLATUMNew World Imports, Incef89a68a-74c1-4c42-8078-b7a208ace0de2026-07-22WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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