TOPCARE MAXIMUM STRENGTH URINARY PAIN RELIEF

Manufacturer: TOPCO ASSOCIATES LLC | Reese Pharmaceutical Co | Contract Pharmacal Corp.
Effective date: 2019-01-30
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:58:23

Label at a glance#

ProductTOPCARE MAXIMUM STRENGTH URINARY PAIN RELIEF

Active ingredientPHENAZOPYRIDINE HYDROCHLORIDE

Label structure12 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

PHENAZOPYRIDINE HYDROCHLORIDE 97.5 MG

PURPOSE

OTC - PURPOSE SECTION

URINARY ANALGESIC

WARNINGS

WARNINGS SECTION

DO NOT EXCEED RECOMMENDED DOSAGE

ASK DOCTOR SECTION

OTC - ASK DOCTOR SECTION

ASK DOCTOR BEFORE USE

IF YOU HAVE KIDNEY DISEASE

ALLERGIES TO FOODS,PRESERVATIVES OR DYES

HAD A HYPERSENSITIVE REACTION TO PHENAZOPYRIDINE

WHEN USING SECTION

OTC - WHEN USING SECTION

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 SECTION

OTC - STOP USE SECTION

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

PREGNANCY OR BREAST FEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

ASK A HEALTH PROFESSIONAL BEFORE USE

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

IN CASE OF OVERDOSE ,GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

Use; fast relief from urinary pain,burning,urgency and frequency associated with urinary tract infections.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Adults and Children 12 years of age and over; take 2 tablets 3 times daily with a full glass of water,with or after meals as needed.
Children under 12 years of age; consult a doctor.
Do not use for more than 2 days ( 12 tablets ) without consulting a Doctor.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose,

pharmaceutical glaze, and sodium starch glycolate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1094357	phenazopyridine HCl 97.5 MG Oral Tablet	PSN	2
1094357	phenazopyridine hydrochloride 97.5 MG Oral Tablet	SCD	2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
36800-103-01	2023-01-30	C162847	48780-1	f386c649-e214-0266-e053-dadaa90a7c1a	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-103-01	TOPCARE MAXIMUM STRENGTH URINARY PAIN RELIEF	1 in 1 CARTON	TABLET	1		2
36800-103-12	TOPCARE MAXIMUM STRENGTH URINARY PAIN RELIEF	12 in 1 BLISTER PACK	TABLET	12		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-103	TOPCARE MAXIMUM STRENGTH URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]	2	Legacy NDC, 2 package rows	20190131_2d3fcf6d-5965-425c-896b-a3b895e4fd44.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
PHENAZOPYRIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	0EWG668W17	1
PHENAZOPYRIDINE	ACTIVE MOIETY	K2J09EMJ52	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	1
MAGNESIUM SILICATE	INACTIVE INGREDIENT	9B9691B2N9	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

TOPCARE MAXIMUM STRENGTH URINARY PAIN RELIEF
PHENAZOPYRIDINE HYDROCHLORIDE
PHENAZOPYRIDINE
LACTOSE
MAGNESIUM SILICATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
36800-103	36800-103-12, 36800-103-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PHENAZOPYRIDINE HYDROCHLORIDE	0EWG668W17	ACTIB
LACTOSE	J2B2A4N98G	IACT
MAGNESIUM SILICATE	9B9691B2N9	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 46 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, SOLUTION / INTRAVENOUS	0.45 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, DELAYED RELEASE / ORAL	231.84 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE / RESPIRATORY (INHALATION)	44.4 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION / INTRAVENOUS	203.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY	193.8 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, EXTENDED RELEASE / ORAL	120 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION / INTRAMUSCULAR	203.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE / ORAL	530 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM SILICATE	MAGNESIUM SILICATE	9B9691B2N9	TABLET, DELAYED RELEASE / ORAL		180 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
MAGNESIUM SILICATE	MAGNESIUM SILICATE	9B9691B2N9	CAPSULE / ORAL	40 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / BUCCAL	296.7 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / RECTAL	20 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER / RESPIRATORY (INHALATION)	90 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / SUBLINGUAL		352 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM SILICATE	MAGNESIUM SILICATE	9B9691B2N9	SOAP / TOPICAL	0.33 %w/w		Exact identifier — unii candidate 10 equally ranked IID candidates
MAGNESIUM SILICATE	MAGNESIUM SILICATE	9B9691B2N9	TABLET / SUBLINGUAL	1.2 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, COATED / ORAL	332.05 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CREAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	FILM, EXTENDED RELEASE / TRANSDERMAL	675 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED PELLETS / ORAL	135.2 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EFFERVESCENT / ORAL	96.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, DELAYED RELEASE / ORAL		160 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, CHEWABLE / ORAL		1412 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SOLUTION / ORAL	1682 mg/15ml		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SOLUTION / RECTAL	8 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER / VAGINAL	430 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM SILICATE	MAGNESIUM SILICATE	9B9691B2N9	TABLET, CHEWABLE / ORAL	30 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED / ORAL	590 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / ORAL	2500 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM SILICATE	MAGNESIUM SILICATE	9B9691B2N9	WAFER / ORAL	22 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
MAGNESIUM SILICATE	MAGNESIUM SILICATE	9B9691B2N9	TABLET, COATED / ORAL	29.03 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
MAGNESIUM SILICATE	MAGNESIUM SILICATE	9B9691B2N9	TABLET, FILM COATED / ORAL	33.7 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
MAGNESIUM SILICATE	MAGNESIUM SILICATE	9B9691B2N9	PASTE, DENTIFRICE / DENTAL	0.4 %w/w		Exact identifier — unii candidate 10 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		620 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	GRANULE, FOR SUSPENSION / ORAL	512.5 mg/5ml		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM SILICATE	MAGNESIUM SILICATE	9B9691B2N9	TABLET / ORAL	10 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EXTENDED RELEASE / ORAL	400 mg		Exact identifier — unii candidate 36 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
68b67760-6330-46f4-83f8-835c1f9f787c			2d3fcf6d-5965-425c-896b-a3b895e4fd44	2019-01-30	Warnings	Exact identifier spl id: 68b67760-6330-46f4-83f8-835c1f9f787c spl set id: 2d3fcf6d-5965-425c-896b-a3b895e4fd44

Reported adverse events (FAERS/openFDA)#

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