TopCare Urinary Pain Relief

Product NDC: 36800-040
11-digit product format: 368000040
Labeler code: 36800
Product ID: 36800-040_1666a619-d61a-4b2e-a8c9-997287798d4d
Type: HUMAN OTC DRUG
Nonproprietary name: PHENAZOPYRIDINE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: TOPCO ASSOCIATES LLC
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2013-07-01
Substance: PHENAZOPYRIDINE HYDROCHLORIDE
Active strength: 95 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: TopCare Urinary Pain Relief
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENAZOPYRIDINE HYDROCHLORIDE	95 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0EWG668W17	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1094126	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
2d272b96-c676-4ed8-aa08-df2d41a2ef41	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-040-30	TopCare Urinary Pain Relief	30 in 1 BLISTER PACK	TABLET	30		7
36800-040-30	TopCare Urinary Pain Relief	1 in 1 CARTON	TABLET	1		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
36800-040-30	EA - Each	36800-040	0d1517fb-a3ac-4922-a058-d1690cbc0987	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-040	TOPCARE URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]	7	Current NDC, Legacy NDC, 2 package rows	20241220_2d272b96-c676-4ed8-aa08-df2d41a2ef41.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TopCare Urinary Pain Relief	PHENAZOPYRIDINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	2d272b96-c676-4ed8-aa08-df2d41a2ef41	2024-12-18	Warnings	Exact identifier ndc (product): 36800-040

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0EWG668W17	PHENAZOPYRIDINE HYDROCHLORIDE	136-40-3	PHENAZOPYRIDINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1094126	phenazopyridine HCl 95 MG Oral Tablet	PSN	2d272b96-c676-4ed8-aa08-df2d41a2ef41	7
1094126	phenazopyridine hydrochloride 95 MG Oral Tablet	SCD	2d272b96-c676-4ed8-aa08-df2d41a2ef41	7
1094126	phenazopyridine HCl 95 MG Oral Tablet	SY	2d272b96-c676-4ed8-aa08-df2d41a2ef41	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-040-30	36800004030	1 BLISTER PACK in 1 CARTON (36800-040-30) / 30 TABLET in 1 BLISTER PACK	1 blister pack	2016-07-27	0000-00-00	No	No	Current