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 4 of 29 · 562 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Healing Balm Skin ProtectantPETROLATUMCVSdf711f93-71bd-4fbe-835c-50eaa9c15e072026-06-15WarningsExact identifier
unii: 4T6H12BN9U
Skin Protectant with 33% Petrolatum Advance Moisturizing CreamPETROLATUMAldermed Inc.87413149-d39f-4f8a-b1c9-6de5eb37ff7e2026-06-12WarningsExact identifier
unii: 4T6H12BN9U
Equaline HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMUnited Natural Foods, Inc. dba UNFIbf87824a-522d-46da-81b6-e30ea11a22352026-06-11WarningsExact identifier
unii: 4T6H12BN9U
HEMORRHOIDALMINERAL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY, INC93482a9b-145b-42d4-96db-599c281a39f12026-06-10WarningsExact identifier
unii: 4T6H12BN9U
SUPRADERMWHITE PETROLATUM, LANOLINOlen Skin Care Corporation4e7199bd-52c6-48e9-9c78-c84e45412faf2026-06-10WarningsExact identifier
unii: 4T6H12BN9U
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMHyVee Incb867f691-7a13-4659-b664-06aa368993102026-06-03WarningsExact identifier
unii: 4T6H12BN9U
ADVANCED HEALINGPETROLATUMRejoice International Corp.532c7e5a-4d05-3bd0-e063-6294a90aee002026-06-01WarningsExact identifier
unii: 4T6H12BN9U
ADVANCED HEALING BALMPETROLATUMRejoice International Corp.53285d82-3755-ca78-e063-6394a90a50192026-05-31WarningsExact identifier
unii: 4T6H12BN9U
PURE PETROLATUMPETROLATUMVASA COSMETICS PRIVATE LIMITED52efd466-49bd-bbdf-e063-6394a90aa1082026-05-28WarningsExact identifier
unii: 4T6H12BN9U
TheraCare Vitamin A and D plus EPETROLATUMVeridian Healthcare52e0e248-6c04-feb9-e063-6394a90add462026-05-28WarningsExact identifier
unii: 4T6H12BN9U
Advanced HealingPETROLATUMCVS Pharamacy, Inc0bd3380e-2284-44a7-b2ef-68c9909627fd2026-05-26Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
CeraVe Developed with Dermatologists Healing Lip BalmPETROLATUML'Oreal USA Products Inc21dc8842-0672-4d46-bcea-b8e3d54c48bf2026-05-20WarningsExact identifier
unii: 4T6H12BN9U
REFRESH LACRI-LUBEMINERAL OIL, PETROLATUMAllergan, Inc.d232a44b-516d-4cdf-a4e7-c3a9a50dc7af2026-05-15WarningsExact identifier
unii: 4T6H12BN9U
Cerave Developed with Dermatologists HealingPETROLATUMLOreal USA Products Incde44ac01-ba17-4f97-ac12-9ea348013bde2026-05-14WarningsExact identifier
unii: 4T6H12BN9U
HydratingPETROLATUMAldermed Inc.4aa6a354-e487-4b65-e063-6394a90abbf02026-05-09WarningsExact identifier
unii: 4T6H12BN9U
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: 4T6H12BN9U
WELL AT WALGREENS BABY ADVANCED HEALINGPETROLATUMWALGREEN COMPANY75067953-4cd8-4fcb-b7b7-dd0d2200642d2026-05-05WarningsExact identifier
unii: 4T6H12BN9U
Dry Skin HealingPETROLATUMWalgreen0397507d-4b6e-c679-e063-6294a90a0b332026-05-03WarningsExact identifier
unii: 4T6H12BN9U
CVSPETROLATUMApollo Health and Beauty Care47d2b9be-91ad-e9e2-e063-6294a90ac29f2026-04-30WarningsExact identifier
unii: 4T6H12BN9U
PURE PETROLATUMPETROLATUMMY IMPORTS USA LLC4fba8bc7-590d-f621-e063-6294a90ad8c92026-04-18WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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