FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
70518-0218
11-digit product format
705180218
Labeler code
70518
Product ID
70518-0218_4b1ed8b2-57fd-854f-e063-6294a90a9154
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2017-02-14
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-021870518-0218-1DDiscontinued by firm2026-07-31
excluded packagepackage70518-021870518-0218-2DDiscontinued by firm2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEREMEDYREPACK INC.7e131f69-d259-404d-a859-0497f5cbe8562026-06-24Adverse reactionsExact identifier

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

ADVERSE REACTIONS Headache, rash, pruritus and occasional gastrointestinal disturbance. An anaphylactoid-like reaction has been described. Methemoglobinemia, hemolytic anemia, renal and hepatic toxicity have been reported, usually at overdosage levels (see OVERDOSAGE Section).

Additional Listing Data#

Finished product
Yes
Brand name base
Phenazopyridine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENAZOPYRIDINE HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0EWG668W17
Rxcui1094107

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-0218-0Phenazopyridine Hydrochloride6 in 1 BOTTLE, PLASTICTABLET618
70518-0218-1Phenazopyridine Hydrochloride30 in 1 BLISTER PACKTABLET3018
70518-0218-2Phenazopyridine Hydrochloride10 in 1 BOTTLE, PLASTICTABLET1018
70518-0218-3Phenazopyridine Hydrochloride12 in 1 BOTTLE, PLASTICTABLET1218

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0218PHENAZOPYRIDINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]12Current NDC, Legacy NDC, 4 package rows20250425_7e131f69-d259-404d-a859-0497f5cbe856.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094107phenazopyridine HCl 100 MG Oral TabletPSN7e131f69-d259-404d-a859-0497f5cbe85618
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD7e131f69-d259-404d-a859-0497f5cbe85618

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-0218-0705180218006 TABLET in 1 BOTTLE, PLASTIC (70518-0218-0) 6 tablet2017-02-14NoNoCurrent
70518-0218-17051802180130 in 1 BLISTER PACKHistorical
70518-0218-27051802180210 in 1 BOTTLE, PLASTICHistorical
70518-0218-37051802180312 TABLET in 1 BOTTLE, PLASTIC (70518-0218-3) 12 tablet2026-01-11NoNoCurrent