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 9 of 19 · 373 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener Extra StrengthDOCUSATE SODIUMChain Drug Consortium, LLC550000ba-0d6d-4666-8461-f591c14478b12025-06-27WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMChain Drug Consortium, LLC09449649-fd57-4446-8264-6c3bdd6621d02025-06-27WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMTARGET CORPORATION28fce2e2-2101-df88-e063-6394a90aa3de2025-06-25WarningsExact identifier
unii: F05Q2T2JA0
Senna-S SoftgelSENNOSIDES 8.6 MG AND DOCUSATE SODIUM 50 MGNUVICARE LLC65a1cce7-984f-490a-bd68-fea97733a72f2025-06-24WarningsExact identifier
unii: F05Q2T2JA0
ProlaxaDOCUSATE SODIUM 250MGTerrain Pharmaceuticals32610e42-f352-09fd-e063-6394a90abff62025-06-12WarningsExact identifier
unii: F05Q2T2JA0
DOCUZENSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGVillage Pharma29102014-9b0e-4899-958d-83111f94a6122025-06-01WarningsExact identifier
unii: F05Q2T2JA0
CHLORZOXAZONECHLORZOXAZONEAdvanced Rx of Tennessee, LLC36c1eb43-8840-8d84-e063-6394a90addca2025-05-29Warnings, Adverse reactionsExact identifier
unii: H0DE420U8G
Insecticides/Pest/Food Additives DetoxBOLDO, 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, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: OJ245FE5EU
Stool Softener LaxativeDOCUSATE SODIUMWalgreens816c82f8-0fa5-4b22-a226-e8f22f3eaa1d2025-05-23WarningsExact identifier
unii: F05Q2T2JA0
SODIUM PHENYLACETATE and SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEOmnivium Pharmaceuticals LLC8fafc39b-69db-40f3-8a09-ee859e8cef192025-05-15Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
COLACE EXTRA STRENGTH STOOL SOFTNERDOCUSATE SODIUMAtlantis Consumer Healthcare Inc.34e06b05-64a5-4b3e-af38-cdcd7c1d521b2025-05-01WarningsExact identifier
unii: F05Q2T2JA0
Docusate SodiumDOCUSATE SODIUMBelleview Bio Science335f41d7-5c22-7c17-e063-6294a90a8f282025-04-22WarningsExact identifier
unii: F05Q2T2JA0
Docusate SodiumDOCUSATE SODIUMAmerican Health Packaginge5028f6d-d33d-47a9-8453-00af5cdf59a62025-04-20WarningsExact identifier
unii: F05Q2T2JA0
Docusate Sodium Oral LiquidDOCUSATE SODIUM ORAL LIQUIDKesin Pharma Corporation331277b8-8304-d082-e063-6394a90a4dd32025-04-18WarningsExact identifier
unii: F05Q2T2JA0
SODIUM PHENYLACETATE and SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEAilex Pharmaceuticals, LLC329655ae-c3c0-46b2-a925-e49777f2076b2025-03-30Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Senna-SSENNOSIDES AND DOCUSATE SODIUMMeijer, Inc.2619be6e-877b-16a2-e063-6394a90a68da2025-03-24WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESMeijer, Inc.261a88d6-87d2-7544-e063-6294a90a2e942025-03-24WarningsExact identifier
unii: F05Q2T2JA0
CHLORZOXAZONECHLORZOXAZONEAdvanced Rx of Tennessee, LLC30c9b3ce-198d-0c16-e063-6394a90a857d2025-03-20Warnings, Adverse reactionsExact identifier
unii: H0DE420U8G
CVS Health Stool Softener Plus stimulant laxative SoftgelDOCUSATE SODIUM, SENNOSIDESCVS Pharmacy, Inc2881d83d-9929-677a-e063-6394a90a04242025-03-19WarningsExact identifier
unii: F05Q2T2JA0
ChlorzoxazoneCHLORZOXAZONELifsa Drugs LLC0f222059-1ece-44f3-ae7f-d277e5bcaba42025-03-16Warnings, Adverse reactionsExact identifier
unii: H0DE420U8G

Reported adverse events (FAERS/openFDA)#

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