TopCare Maximum Strength Urinary Pain Relief

Product NDC
36800-510
11-digit product format
368000510
Labeler code
36800
Product ID
36800-510_e5d6a5af-cd8f-4afa-9fc4-1a646002ce81
Type
HUMAN OTC DRUG
Nonproprietary name
PHENAZOPYRIDINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
TOPCO ASSOCIATES LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2010-01-04
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
99.5 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
TopCare Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDETOPCO ASSOCIATES LLC1662f712-6756-4dcd-bdfa-b4ed28c0d69a2024-12-18WarningsExact identifier

Warnings cross-check#

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

warnings

Warnings Do not exceed recommended dosage

Additional Listing Data#

Finished product
Yes
Brand name base
TopCare Maximum Strength Urinary Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENAZOPYRIDINE HYDROCHLORIDE99.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0EWG668W17
Rxcui1094147

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-510-12TopCare Maximum Strength Urinary Pain Relief1 in 1 CARTONTABLET14
36800-510-12TopCare Maximum Strength Urinary Pain Relief12 in 1 BLISTER PACKTABLET124

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-510TOPCARE MAXIMUM STRENGTH URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]4Current NDC, Legacy NDC, 2 package rows20241220_1662f712-6756-4dcd-bdfa-b4ed28c0d69a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094147phenazopyridine HCl 99.5 MG Oral TabletPSN1662f712-6756-4dcd-bdfa-b4ed28c0d69a4
1094147phenazopyridine hydrochloride 99.5 MG Oral TabletSCD1662f712-6756-4dcd-bdfa-b4ed28c0d69a4
1094147phenazopyridine HCl 99.5 MG Oral TabletSY1662f712-6756-4dcd-bdfa-b4ed28c0d69a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-510-12368000510121 BLISTER PACK in 1 CARTON (36800-510-12) / 12 TABLET in 1 BLISTER PACK1 blister pack2019-11-140000-00-00NoNoCurrent