FDA.reportPublic FDA data

NDC 80425-0507-01 - CHLORZOXAZONE

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
80425-0507
Requested NDC
80425-0507-01
Package NDCs from labels
80425-0507-1, 80425-0507-2, 80425-0507-3, 80425-0507-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2025-03-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CHLORZOXAZONE - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2025-03-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0507-1CHLORZOXAZONE30 in 1 BOTTLETABLET301
80425-0507-2CHLORZOXAZONE60 in 1 BOTTLETABLET601
80425-0507-3CHLORZOXAZONE90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0507CHLORZOXAZONE TABLET [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 3 package rows20250322_30c9b3ce-198d-0c16-e063-6394a90a857d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0507-1EA - Each80425-050790db2596-d4b9-4bce-97ca-3453f24ef58f12025-05-14
80425-0507-2EA - Each80425-0507dc53fbe8-bd7e-4d12-b134-8cc1b9a5f44412025-05-14
80425-0507-3EA - Each80425-0507e8840893-9961-4080-b38f-48207fa9e30812025-05-14

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 · 372 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
rxcui: 1088936
rxcui: 1088934
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
application number: ANDA213126
ndc (package): 80425-0507-3
ndc (package): 80425-0507-1
ndc (package): 80425-0507-2
ndc (product): 80425-0507
ndc11 (package): 80425050701
rxcui: 197502
spl id: 30c9d90b-eba6-17be-e063-6394a90a8408
spl set id: 30c9b3ce-198d-0c16-e063-6394a90a857d
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.