FDA.reportPublic FDA data

NDC 70518-4364-01 - 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
70518-4364
Requested NDC
70518-4364-01
Package NDCs from labels
70518-4364-0, 70518-4364-1, 70518-4364-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-01-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Chlorzoxazone Tablets, USPREMEDYREPACK INC.2026-01-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4364-0CHLORZOXAZONE90 in 1 BOTTLE, PLASTICTABLET902
70518-4364-1CHLORZOXAZONE60 in 1 BOTTLE, PLASTICTABLET602

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 1 of 3 · 42 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChlorzoxazoneCHLORZOXAZONEPar Health USA, LLC7c5a835d-3754-4c25-a0e2-335b8eceb2d22026-08-31Warnings, Adverse reactionsExact identifier
rxcui: 1088936
rxcui: 1088934
unii: H0DE420U8G
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
Rohto Cool ReliefNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companydc8f1ff3-87ae-47ca-815f-5a0e34f8cf302026-06-19WarningsExact identifier
unii: 6OZP39ZG8H
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
CHLORZOXAZONECHLORZOXAZONEBryant Ranch Prepack6c77ca6b-fda6-43ab-8179-3e0bde6aa65f2026-04-13Warnings, Adverse reactionsExact identifier
rxcui: 197502
unii: H0DE420U8G
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: 6OZP39ZG8H
CHLORZOXAZONECHLORZOXAZONEREMEDYREPACK INC.3f73a1d1-b3ee-4678-bc02-3258ec8121272026-01-29Warnings, Adverse reactionsExact identifier
application number: ANDA089853
ndc (package): 70518-4364-0
ndc (package): 70518-4364-1
ndc (product): 70518-4364
ndc11 (package): 70518436401
rxcui: 197502
spl id: 4986f0f6-a218-6af3-e063-6394a90a34d3
spl set id: 3f73a1d1-b3ee-4678-bc02-3258ec812127
unii: H0DE420U8G
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
ChlorzoxazoneCHLORZOXAZONEPD-Rx Pharmaceuticals, Inc.8650d342-92df-48d7-9f3d-cdd6f6f4c0e72025-10-20Warnings, Adverse reactionsExact identifier
rxcui: 197502
unii: H0DE420U8G
CHLORZOXAZONECHLORZOXAZONEHappy Robin, LLC3f90c7bc-118f-4371-e063-6394a90a279a2025-10-08Warnings, Adverse reactionsExact identifier
unii: H0DE420U8G
chlorzoxazoneCHLORZOXAZONESolubiomixc3d40a90-6df8-4b44-bc61-d7655c52bacb2025-10-06Warnings, Adverse reactionsExact identifier
unii: H0DE420U8G
ChlorzoxazoneCHLORZOXAZONERising Pharma Holdings, Inc.e0d10d67-9716-450b-b8a9-4e157008864e2025-09-17Warnings, Adverse reactionsExact identifier
unii: H0DE420U8G
CHLORZOXAZONECHLORZOXAZONEAdvanced Rx of Tennessee, LLC36c1eb43-8840-8d84-e063-6394a90addca2025-05-29Warnings, Adverse reactionsExact identifier
application number: ANDA089853
rxcui: 1088936
rxcui: 1088934
unii: H0DE420U8G
CHLORZOXAZONECHLORZOXAZONEAdvanced Rx of Tennessee, LLC30c9b3ce-198d-0c16-e063-6394a90a857d2025-03-20Warnings, Adverse reactionsExact identifier
rxcui: 197502
unii: H0DE420U8G
ChlorzoxazoneCHLORZOXAZONELifsa Drugs LLC0f222059-1ece-44f3-ae7f-d277e5bcaba42025-03-16Warnings, Adverse reactionsExact identifier
unii: H0DE420U8G
CHLORZOXAZONECHLORZOXAZONECamber Pharmaceuticals, Inc.e9bb9ebf-fceb-4da8-950a-c4b1fd5a84f12025-03-16Warnings, Adverse reactionsExact identifier
unii: H0DE420U8G
CHLORZOXAZONECHLORZOXAZONEProficient Rx LP0a8ee5fa-f393-4568-81bd-269f9a4cecd62025-03-01Warnings, Adverse reactionsExact identifier
application number: ANDA089853
rxcui: 197502
unii: H0DE420U8G

Reported adverse events (FAERS/openFDA)#

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