FDA.reportPublic FDA data

Quality Choice Maximum Strength Urinary Pain Relief

Product NDC
63868-297
11-digit product format
638680297
Labeler code
63868
Product ID
63868-297_216ec603-9401-43e9-b01a-e8482894ad49
Type
HUMAN OTC DRUG
Nonproprietary name
PHENAZOPYRIDINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Chain Drug Marketing Association
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2019-08-15
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
99.5 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENAZOPYRIDINE HYDROCHLORIDE99.5 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
1094147Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3107c7c3-d5f6-410c-a1de-c6847f0fb4c7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-297-12Quality Choice Maximum Strength Urinary Pain Relief1 in 1 CARTONTABLET15
63868-297-12Quality Choice Maximum Strength Urinary Pain Relief12 in 1 BLISTER PACKTABLET125
63868-297-24Quality Choice Maximum Strength Urinary Pain Relief1 in 1 CARTONTABLET15
63868-297-24Quality Choice Maximum Strength Urinary Pain Relief24 in 1 BLISTER PACKTABLET245

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-297-12EA - Each63868-297b7189afc-dfb7-4a96-9677-0a78e49c27e812022-10-06
63868-297-24EA - Each63868-297e927b8cb-4252-4b7b-81f8-92ea1a7eecff12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-297QUALITY CHOICE MAXIMUM STRENGTH URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [CHAIN DRUG MARKETING ASSOCIATION]5Current NDC, Legacy NDC, 4 package rows20241220_3107c7c3-d5f6-410c-a1de-c6847f0fb4c7.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
Quality Choice Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEChain Drug Marketing Association3107c7c3-d5f6-410c-a1de-c6847f0fb4c72024-12-18WarningsExact identifier
ndc (product): 63868-297

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094147phenazopyridine HCl 99.5 MG Oral TabletPSN3107c7c3-d5f6-410c-a1de-c6847f0fb4c75
1094147phenazopyridine hydrochloride 99.5 MG Oral TabletSCD3107c7c3-d5f6-410c-a1de-c6847f0fb4c75
1094147phenazopyridine HCl 99.5 MG Oral TabletSY3107c7c3-d5f6-410c-a1de-c6847f0fb4c75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-297-12638680297121 BLISTER PACK in 1 CARTON (63868-297-12) / 12 TABLET in 1 BLISTER PACK1 blister pack2019-08-150000-00-00NoNoCurrent
63868-297-24638680297241 BLISTER PACK in 1 CARTON (63868-297-24) / 24 TABLET in 1 BLISTER PACK1 blister pack2019-08-150000-00-00NoNoCurrent