RIGHT REMEDIES Maximum Strength Urinary Pain Relief

Product NDC
70692-163
11-digit product format
706920163
Labeler code
70692
Product ID
70692-163_968a35be-57d2-438e-b8c6-8b1f74e2f79d
Type
HUMAN OTC DRUG
Nonproprietary name
Phenazopyridine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Strive Pharmaceuticals Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-12-01
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
RIGHT REMEDIES Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEStrive Pharmaceuticals Inc.3fb23c2e-56b7-4f49-b3f1-5e5f07d61d202023-11-22WarningsExact identifier

Warnings cross-check#

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

warnings

Warnings Do not exceed recommended dosage Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician. Ask a doctor before use if you have • kidney disease • allergies to foods, preservatives or dyes • had a hypersensitive reaction to Phenazopyridine Hydrochloride When using this product • stomach upset may occur, taking this product with or after meals may reduce stomach upset • your urine will become reddish orange in color. This is not harmful, but care should be taken to avoid staining clothing or other items. Stop use and ask a doctor if • your symptoms last for more than 2 days • you suspect you are having an adverse reaction to the medication. Long-term administration of Phenazopyridine HCl has induced neoplasia in rats (large intestine) and mice (liver). Although no association between Phenazopyridine HCl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted. If pregnant or breastfeeding , ask a health professional before use. A pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use. Keep out of reach of children. In case of an overdose, get medical help or contact a Poison Control Center right away.

Additional Listing Data#

Finished product
Yes
Brand name base
RIGHT REMEDIES 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
70692-163-39RIGHT REMEDIES Maximum Strength Urinary Pain Relief3 in 1 CARTONTABLET31
70692-163-39RIGHT REMEDIES Maximum Strength Urinary Pain Relief24 in 1 BLISTER PACKTABLET241

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70692-163RIGHT REMEDIES MAXIMUM STRENGTH URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [STRIVE PHARMACEUTICALS INC.]1Current NDC, 2 package rows20231207_3fb23c2e-56b7-4f49-b3f1-5e5f07d61d20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094147phenazopyridine HCl 99.5 MG Oral TabletPSN3fb23c2e-56b7-4f49-b3f1-5e5f07d61d201
1094147phenazopyridine hydrochloride 99.5 MG Oral TabletSCD3fb23c2e-56b7-4f49-b3f1-5e5f07d61d201
1094147phenazopyridine HCl 99.5 MG Oral TabletSY3fb23c2e-56b7-4f49-b3f1-5e5f07d61d201

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70692-163-39706920163393 BLISTER PACK in 1 CARTON (70692-163-39) / 24 TABLET in 1 BLISTER PACK3 blister pack2023-12-01NoNoCurrent