FDA.reportPublic FDA data

NDC 68025-047-01 - Lorzone

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
68025-047
Requested NDC
68025-047-01
Package NDCs from labels
68025-047-10, 68025-047-01, 68025-047-02
Manufacturer
Vertical Pharmaceuticals, Inc.
Effective date
2023-09-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LorzoneVertical Pharmaceuticals, Inc.2023-09-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68025-047-10EA - Each68025-0477d8728a7-8b74-4dcd-b339-4d2b5abfe61f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORZOXAZONEACTIVE INGREDIENTH0DE420U8GLORZONE (CHLORZOXAZONE) TABLET [VERTICAL PHARMACEUTICALS, LLC]2
CHLORZOXAZONEACTIVE MOIETYH0DE420U8GLORZONE (CHLORZOXAZONE) TABLET [VERTICAL PHARMACEUTICALS, LLC]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLORZONE (CHLORZOXAZONE) TABLET [VERTICAL PHARMACEUTICALS, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORZONE (CHLORZOXAZONE) TABLET [VERTICAL PHARMACEUTICALS, LLC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LORZONE (CHLORZOXAZONE) TABLET [VERTICAL PHARMACEUTICALS, LLC]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0LORZONE (CHLORZOXAZONE) TABLET [VERTICAL PHARMACEUTICALS, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORZONE (CHLORZOXAZONE) TABLET [VERTICAL PHARMACEUTICALS, LLC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EULORZONE (CHLORZOXAZONE) TABLET [VERTICAL PHARMACEUTICALS, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLORZONE (CHLORZOXAZONE) TABLET [VERTICAL PHARMACEUTICALS, LLC]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 13 of 19 · 373 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
STOOL SOFTENERDOCUSATE SODIUMWalgreen Co.d8d97ca5-5131-4620-8ce9-bc3f9d5c0ab52024-11-21WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUM 100MGPuraCap Pharmaceutical LLC272c86f1-f229-2ebf-e063-6394a90a34712024-11-18WarningsExact identifier
unii: F05Q2T2JA0
Docusate SodiumDOCUSATE SODIUMA-S Medication Solutions122486e9-74dd-4181-97d1-0b07688280f42024-11-06WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener with LaxativeDOCUSATE SODIUM AND SENNOSIDESBryant Ranch Prepacke24638d3-7738-4185-8ce9-1845d8594cc62024-11-04WarningsExact identifier
unii: F05Q2T2JA0
DOCUSATE SODIUMDOCUSATE SODIUMNuCare Pharmaceuticals,Inc.fdf3c8e1-d554-4cdb-e053-6394a90a542e2024-11-01WarningsExact identifier
unii: F05Q2T2JA0
AddiclenzBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.8a3b75ca-8fec-4318-8a55-8bde0b82637d2024-10-31WarningsExact identifier
unii: OJ245FE5EU
Stool SoftenerDOCUSATE SODIUM AND SENNOSIDESBETTER LIVING BRANDS LLC.f2c61c71-9a23-4bd3-e053-2a95a90ad4602024-10-26WarningsExact identifier
unii: F05Q2T2JA0
DOCUSATE SODIUMDOCUSATE SODIUMSam's West Incb0e99ebb-41fc-459f-86d2-f0e3527f97b02024-10-24WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMA-S Medication Solutionsef05ad45-7082-43e6-9533-a79c5aa0f3732024-10-22WarningsExact identifier
unii: F05Q2T2JA0
ChlorzoxazoneCHLORZOXAZONEBryant Ranch Prepack5e6889c9-a091-4622-0a00-ad0fc1830f782024-10-08Warnings, Adverse reactionsExact identifier
unii: H0DE420U8G
exchange select stool softenerDOCUSATE SODIUMArmy & Air Force Exchange Service14985848-d791-42b9-ad7e-810a85bb1ee12024-10-07WarningsExact identifier
unii: F05Q2T2JA0
Senna-SSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGProficient Rx LP8678a3ee-0e2c-4c95-ad2e-83aa601f32382024-10-01WarningsExact identifier
unii: F05Q2T2JA0
Pedia-LaxDOCUSATE SODIUMC.B. Fleet Company, Inc.0e908bea-ebab-44e7-919c-90002e6f5d422024-10-01WarningsExact identifier
unii: F05Q2T2JA0
SODIUM PHENYLACETATE AND SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEZydus Pharmaceuticals USA Inc.204e84a7-5440-4537-9e40-06eb56c415e92024-09-30Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Sodium Phenylacetate and sodium benzoateSODIUM PHENYLACETATE AND SODIUM BENZOATENavinta LLCfbc7bfe3-6faa-45a3-befb-9ad7963c05712024-09-30Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Natural Vegetable Laxative and Stool SoftenerDOCUSATE SODIUM AND SENNOSIDESBETTER LIVING BRANDS LLC.f2c562e1-4080-44cb-e053-2a95a90a42222024-09-25WarningsExact identifier
unii: F05Q2T2JA0
SENNA-S LAXATIVE WITH STOOL SOFTENERSENNOSIDESBasic Drugs, Inc.d32b9956-fc04-8d64-e053-2a95a90a17b32024-09-14WarningsExact identifier
unii: F05Q2T2JA0
DOCUSATE SODIUM, EXTRA STRENGTH 250 MGDOCUSATE SODIUMAdvanced Rx LLCe8be12c5-c591-eadd-e053-2a95a90a431b2024-09-13WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESH E B4fcfb8ff-5b99-4bb3-9a2b-c95f47d74b8b2024-09-09WarningsExact identifier
unii: F05Q2T2JA0
CHLORZOXAZONECHLORZOXAZONEBryant Ranch Prepackd7f09907-83b2-46cf-947d-fa38dcf886852024-09-09Warnings, Adverse reactionsExact identifier
unii: H0DE420U8G

Reported adverse events (FAERS/openFDA)#

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