Uricalm

Product NDC: 52389-241
11-digit product format: 523890241
Labeler code: 52389
Product ID: 52389-241_316e93e7-3627-8e6a-e063-6294a90a1d28
Type: HUMAN OTC DRUG
Nonproprietary name: Phenazopyridine Hydochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Kobayashi Healthcare International, Inc.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2008-04-29
Substance: PHENAZOPYRIDINE HYDROCHLORIDE
Active strength: 99.5 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	52389-241	52389-241-12	D	Discontinued by firm		2026-08-17
excluded package	package	52389-241	52389-241-36	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	52389-241-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	52389-241-36	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	52389-241-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	52389-241-36	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	52389-241-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	52389-241-36	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	52389-241-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	52389-241-36	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	52389-241-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	52389-241-36	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	52389-241-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	52389-241-36	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	52389-241-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	52389-241-36	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	52389-241-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	52389-241-36	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	52389-241-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	52389-241-36	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	52389-241-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	52389-241-36	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	52389-241-12	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	52389-241-36	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	52389-241-12	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	52389-241-36	`557ba5c1ecfa…`	`9c80585c8c6e…`

Additional Listing Data#

Finished product: Yes
Brand name base: Uricalm
Brand name suffix: Maximum Strength
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENAZOPYRIDINE HYDROCHLORIDE	99.5 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1094147	Internal RxNorm lookup
1094149	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
1d94b45c-ee0b-499d-aca2-e8cd8dd490d2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52389-241-01	UricalmMaximum Strength	24 in 1 BLISTER PACK	TABLET, FILM COATED	24	18
52389-241-02	UricalmMaximum Strength	12 in 1 BLISTER PACK	TABLET, FILM COATED	12	18
52389-241-03	UricalmMaximum Strength	36 in 1 BLISTER PACK	TABLET, FILM COATED	36	18
52389-241-04	UricalmMaximum Strength	28 in 1 BLISTER PACK	TABLET, FILM COATED	28	18
52389-241-12	UricalmMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	18
52389-241-24	UricalmMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	18
52389-241-28	UricalmMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	18
52389-241-36	UricalmMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	18
52389-241-48	UricalmMaximum Strength	2 in 1 CARTON	TABLET, FILM COATED	2	18
52389-241-48	UricalmMaximum Strength	24 in 1 BLISTER PACK	TABLET, FILM COATED	24	18

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Phenazopyridine hydrochloride	ACTIVE INGREDIENT	0EWG668W17	URICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	5
Phenazopyridine	ACTIVE MOIETY	K2J09EMJ52	URICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	URICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	5
Cranberry	INACTIVE INGREDIENT	0MVO31Q3QS	URICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	URICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	5
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	URICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	5
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	URICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	5
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	URICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	URICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	5
Mineral oil	INACTIVE INGREDIENT	T5L8T28FGP	URICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	5
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	URICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	5
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	URICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	URICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	URICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	URICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	5
Titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	URICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	5
Triacetin	INACTIVE INGREDIENT	XHX3C3X673	URICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52389-241	URICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]	18	Current NDC, Legacy NDC, 10 package rows	20250331_1d94b45c-ee0b-499d-aca2-e8cd8dd490d2.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
Uricalm Maximum Strength	PHENAZOPYRIDINE HYDOCHLORIDE	Kobayashi Healthcare International, Inc.	1d94b45c-ee0b-499d-aca2-e8cd8dd490d2	2025-03-28	Warnings	Exact identifier ndc (product): 52389-241

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
1094147	phenazopyridine HCl 99.5 MG Oral Tablet	PSN	1d94b45c-ee0b-499d-aca2-e8cd8dd490d2	18
1094149	Uricalm Maximum Strength 99.5 MG Oral Tablet	PSN	1d94b45c-ee0b-499d-aca2-e8cd8dd490d2	18
1094149	phenazopyridine hydrochloride 99.5 MG Oral Tablet [Uricalm]	SBD	1d94b45c-ee0b-499d-aca2-e8cd8dd490d2	18
1094147	phenazopyridine hydrochloride 99.5 MG Oral Tablet	SCD	1d94b45c-ee0b-499d-aca2-e8cd8dd490d2	18
1094147	phenazopyridine HCl 99.5 MG Oral Tablet	SY	1d94b45c-ee0b-499d-aca2-e8cd8dd490d2	18
1094149	Uricalm 99.5 MG Oral Tablet	SY	1d94b45c-ee0b-499d-aca2-e8cd8dd490d2	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52389-241-01	52389024101	24 in 1 BLISTER PACK						Historical
52389-241-02	52389024102	12 in 1 BLISTER PACK						Historical
52389-241-03	52389024103	36 in 1 BLISTER PACK						Historical
52389-241-04	52389024104	28 in 1 BLISTER PACK						Historical
52389-241-12	52389024112	1 in 1 CARTON						Historical
52389-241-24	52389024124	1 BLISTER PACK in 1 CARTON (52389-241-24) / 24 TABLET, FILM COATED in 1 BLISTER PACK (52389-241-01)	1 blister pack	2008-04-29	0000-00-00	No	No	Current
52389-241-28	52389024128	1 BLISTER PACK in 1 CARTON (52389-241-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK (52389-241-04)	1 blister pack	2014-02-20	0000-00-00	No	No	Current
52389-241-36	52389024136	1 in 1 CARTON						Historical
52389-241-48	52389024148	2 BLISTER PACK in 1 CARTON (52389-241-48) / 24 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	2021-10-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Uricalm	Kobayashi Healthcare International, Inc. \| Kobayashi America Manufacturing, LLC	2025-03-28	HUMAN OTC DRUG LABEL	18