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 18 of 19 · 371 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOCUZENSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGProficient Rx LP92879e62-f60a-4ab4-9532-610cdd2628ee2023-11-01WarningsExact identifier
unii: F05Q2T2JA0
Docusate SodiumDOCUSATE SODIUMA-S Medication Solutions5999904a-6ac8-4d9e-951c-6e64e8cd93eb2023-11-01WarningsExact identifier
unii: F05Q2T2JA0
Sodium phenylacetate and Sodium benzoateSODIUM PHENYLACETATE AND SODIUM BENZOATEZydus Pharmaceuticals USA Inc.0f17c50f-3761-4470-bf3b-63837a287b8a2023-10-30Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Stool Softener Docusate SodiumDOCUSATE SODIUMMagno-Humphries, Inc.a0e6ab9b-fd31-45fd-93d5-b51d705c180a2023-10-27WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Docusate SodiumDOCUSATE SODIUMMagno-Humphries, Inc.9d22d642-8aed-d17e-e053-2995a90ae1822023-10-27WarningsExact identifier
unii: F05Q2T2JA0
Senna SDOCUSATE SODIUM, SENNOSIDESMagno-Humphries, Inc.9deaf264-6af0-40ba-e053-2a95a90ada0e2023-10-27WarningsExact identifier
unii: F05Q2T2JA0
DOKDOCUSATE SODIUMMAJOR PHARMACEUTICALS7a92070d-98cc-662f-e053-2991aa0aa1b22023-10-23WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMKROGER COMPANYa1afaa71-7e8c-5a49-e053-2a95a90a4db02023-10-23WarningsExact identifier
unii: F05Q2T2JA0
SENNA-SSENNA AND DOCUSATE SODIUM TABLETS, 8.6 MG AND 50 MGHealthLife of USA LLC02a5299c-4b0d-47ac-9838-afd0b0fdd4a62023-10-21WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMGeri-Care Pharmaceutical Corp644d81ec-d38f-4172-a087-727b94e2fefe2023-10-19WarningsExact identifier
unii: F05Q2T2JA0
Docusate SodiumDOCUSATE SODIUMAsclemed USA, Inc.30fc8c07-c26b-4bcc-a727-6e193f5727fd2023-10-16WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Extra StrengthDOCUSATE SODIUMMEIJER, INC.e43bd2ed-17c7-4530-af72-81a7ad70069c2023-10-12WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESCare One (Retail Business Services, LLC.)9adaec97-43e3-48f2-96c8-c508b693676c2023-10-05WarningsExact identifier
unii: F05Q2T2JA0
CHLORZOXAZONECHLORZOXAZONEAurobindo Pharma Limited52d3aa2c-f88f-4de7-b5ae-df8a46e948792023-09-05Warnings, Adverse reactionsExact identifier
rxcui: 1088936
rxcui: 1088934
rxcui: 197502
unii: H0DE420U8G
LipotoxSQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,BioActive Nutritional, Inc.a1538692-ca00-4e52-9b7e-409767ee27e12023-09-05WarningsExact identifier
unii: OJ245FE5EU
ChlorzoxazoneCHLORZOXAZONEMayne Pharma Commercial LLC5238c99e-d36e-4376-ab05-ca2535213d582023-07-06Warnings, Adverse reactionsExact identifier
rxcui: 1088936
rxcui: 1088934
rxcui: 197502
unii: H0DE420U8G
SODIUM PHENYLACETATE AND SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEMAIA PHARMACEUTICALS, INC3529be10-0004-4628-9ca1-67a8acd86b512023-07-05Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
CHLORZOXAZONECHLORZOXAZONERising Pharma Holdings, Inc.1df6058b-7bf2-4246-9827-93fa023a5fd42023-06-09Warnings, Adverse reactionsExact identifier
application number: ANDA213126
ndc (product): 16571-726
rxcui: 1088936
rxcui: 1088934
rxcui: 197502
spl id: b4a7f61d-613e-4d8f-a3fc-37143c6e19c3
spl set id: 1df6058b-7bf2-4246-9827-93fa023a5fd4
unii: H0DE420U8G
ChlorzoxazoneCHLORZOXAZONEBryant Ranch Prepack267a0a2a-b818-47d9-9b61-28be172de99a2023-05-25Warnings, Adverse reactionsExact identifier
rxcui: 197502
unii: H0DE420U8G
CHLORZOXAZONECHLORZOXAZONECintex Services, LLCc95f39c4-0c11-966a-e053-2a95a90a2c182023-05-23Warnings, Adverse reactionsExact identifier
unii: H0DE420U8G

Reported adverse events (FAERS/openFDA)#

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