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 19 of 19 · 371 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChlorzoxazoneCHLORZOXAZONEA-S Medication Solutions6c418b8f-4a1c-4611-80d5-3a3a7dbca9c82023-03-08Warnings, Adverse reactionsExact identifier
rxcui: 197502
unii: H0DE420U8G
Sodium Phenylacetate and Sodium BenzoateSODIUM PHENYLACETATE AND SODIUM BENZOATEMAIA PHARMACEUTICALSab40b62b-9f8d-4394-92d5-09d9f1941eaa2023-01-16Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
AddiclenzBETA VULGARIS, BOLDO, 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.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: OJ245FE5EU
ChlorzoxazoneCHLORZOXAZONEProficient Rx LP63338935-f3dd-4ef1-bb66-856a83c95f412022-04-01Warnings, Adverse reactionsExact identifier
rxcui: 197502
unii: H0DE420U8G
ChlorzoxazoneCHLORZOXAZONENovitium Pharma LLC69c87a85-4b6b-405b-9fa5-4c91c0f90c702021-10-29Warnings, Adverse reactionsExact identifier
rxcui: 197502
unii: H0DE420U8G
Stool SoftenerDOCUSATE SODIUMAllegiant Health9fbe783e-ddd9-445a-852a-00f4ad7548802021-04-20WarningsExact identifier
unii: F05Q2T2JA0
Topcare Stool SoftenerDOCUSATE SODIUMTopCo Associates, LLC6f4fddda-4129-4087-b0e4-ababc55584842021-02-19WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMAllegiant Health30c9ff75-cee4-4632-86fd-acfdf5ee85af2020-10-27WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerMARC GLASSMANMarc Glassman, Inc.909cd222-d836-416f-aa7d-deb4a0c5a5602020-09-08WarningsExact identifier
unii: F05Q2T2JA0
STOOL SOFTENING SENNA LAXATIVESENNOSIDES 8.6 MG - DOCUSATE SODIUM 50 MGTARGET CORPORATION7c74bd91-6687-2b89-e053-2a91aa0ad6b82019-02-28WarningsExact identifier
unii: F05Q2T2JA0
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: OJ245FE5EU

Reported adverse events (FAERS/openFDA)#

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