FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
70518-0218
Requested package NDC
70518-0218-3
11-digit product format
705180218
Labeler code
70518
Product ID
70518-0218_55019fa1-bdb4-d578-e063-6294a90aa15d
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

Reported adverse events (FAERS/openFDA)#

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

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0EWG668W17Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1094107Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7e131f69-d259-404d-a859-0497f5cbe856Available on FDA.report

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

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEREMEDYREPACK INC.7e131f69-d259-404d-a859-0497f5cbe8562026-06-24Adverse reactionsExact identifier
ndc (package): 70518-0218-3
ndc (product): 70518-0218
ndc11 (package): 70518021803

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
70518-0218-37051802180312 TABLET in 1 BOTTLE, PLASTIC (70518-0218-3) 12 tablet2026-01-11NoNoCurrent