Phenazopyridine HCl

Product NDC: 52959-122
11-digit product format: 529590122
Labeler code: 52959
Product ID: 52959-122_76f29754-8711-434f-9548-837d2d608cfd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenazopyridine HCl
Dosage form: TABLET
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2010-09-10
Marketing end: 0000-00-00
Substance: PHENAZOPYRIDINE HYDROCHLORIDE
Active strength: 200 mg/1
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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 · 10 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52959-122		I	Inactivated by FDA	2026-10-05
excluded package	package	52959-122	52959-122-03	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-122	52959-122-04	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-122	52959-122-06	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-122	52959-122-09	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-122	52959-122-10	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-122	52959-122-12	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-122	52959-122-15	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-122	52959-122-20	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-122	52959-122-30	I	Inactivated by FDA	2026-10-05

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 4 · 220 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-122-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-122-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-122-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-122-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-122-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-122-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-122-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-122-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-122-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-122-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-122-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-122-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-122-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-122-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-122-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-122-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-122-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-122-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-122-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-122-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-122-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-122-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-122-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-122-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-122-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-122-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-122-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-122-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-122-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-122-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-122-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-122-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-122-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-122-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-122-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-122-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-122-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-122-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-122-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-122-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-122-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-122-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-122-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-122-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-122-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-122-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-122-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-122-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-122-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-122-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-122-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-122-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-122-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-122-20	`cdf11ea48f46…`	`ba0047e9e063…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
52959-122-03	Phenazopyridine HCl Tablets, USP Rx Only
52959-122-04	Phenazopyridine HCl Tablets, USP Rx Only
52959-122-06	Phenazopyridine HCl Tablets, USP Rx Only
52959-122-09	Phenazopyridine HCl Tablets, USP Rx Only
52959-122-10	Phenazopyridine HCl Tablets, USP Rx Only
52959-122-12	Phenazopyridine HCl Tablets, USP Rx Only
52959-122-15	Phenazopyridine HCl Tablets, USP Rx Only
52959-122-20	Phenazopyridine HCl Tablets, USP Rx Only
52959-122-30	Phenazopyridine HCl Tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52959-122-03	Phenazopyridine HCl	3 in 1 BOTTLE	TABLET	3	1
52959-122-04	Phenazopyridine HCl	4 in 1 BOTTLE	TABLET	4	1
52959-122-06	Phenazopyridine HCl	6 in 1 BOTTLE	TABLET	6	1
52959-122-09	Phenazopyridine HCl	9 in 1 BOTTLE	TABLET	9	1
52959-122-10	Phenazopyridine HCl	10 in 1 BOTTLE	TABLET	10	1
52959-122-12	Phenazopyridine HCl	12 in 1 BOTTLE	TABLET	12	1
52959-122-15	Phenazopyridine HCl	15 in 1 BOTTLE	TABLET	15	1
52959-122-20	Phenazopyridine HCl	20 in 1 BOTTLE	TABLET	20	1
52959-122-30	Phenazopyridine HCl	30 in 1 BOTTLE	TABLET	30	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-122-03	EA - Each	52959-122	89661d1d-c57b-430e-9f0b-2d92fe73b08e	1	2012-07-24
52959-122-04	EA - Each	52959-122	3be933b6-f61f-4d3b-bea3-d4ef95e9d575	1	2012-07-24
52959-122-06	EA - Each	52959-122	0cca5e79-f81b-4c7e-b299-fab9b721f5e1	1	2012-07-24
52959-122-09	EA - Each	52959-122	cc2d817f-1489-4290-943b-34f57b5ba1d6	1	2012-07-24
52959-122-10	EA - Each	52959-122	fd5776b1-e8dd-42e5-8cfc-457313b9f694	1	2012-07-24
52959-122-12	EA - Each	52959-122	f6454523-047a-4a0e-8ef4-14ba945e540c	1	2012-07-24
52959-122-15	EA - Each	52959-122	fddc1c0c-d72a-4a40-b04d-98fa7cef2d56	1	2012-07-24
52959-122-20	EA - Each	52959-122	87a7d8cd-3515-45c0-bf0d-4f8f4753a8c8	1	2012-07-24
52959-122-30	EA - Each	52959-122	6a9cdd2a-e395-4dbf-acd0-7712b9f5fed9	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENAZOPYRIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	0EWG668W17	PHENAZOPYRIDINE HCL TABLET [H.J. HARKINS COMPANY, INC.]	1
PHENAZOPYRIDINE	ACTIVE MOIETY	K2J09EMJ52	PHENAZOPYRIDINE HCL TABLET [H.J. HARKINS COMPANY, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PHENAZOPYRIDINE HCL TABLET [H.J. HARKINS COMPANY, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PHENAZOPYRIDINE HCL TABLET [H.J. HARKINS COMPANY, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PHENAZOPYRIDINE HCL TABLET [H.J. HARKINS COMPANY, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PHENAZOPYRIDINE HCL TABLET [H.J. HARKINS COMPANY, INC.]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	PHENAZOPYRIDINE HCL TABLET [H.J. HARKINS COMPANY, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	PHENAZOPYRIDINE HCL TABLET [H.J. HARKINS COMPANY, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PHENAZOPYRIDINE HCL TABLET [H.J. HARKINS COMPANY, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PHENAZOPYRIDINE HCL TABLET [H.J. HARKINS COMPANY, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-122	PHENAZOPYRIDINE HCL TABLET [H.J. HARKINS COMPANY, INC.]	1	Legacy NDC, 9 package rows	20111214_9bdc6081-e6a7-46f4-9028-c08f3c7c2dca.zip

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
1094104	phenazopyridine HCl 200 MG Oral Tablet	PSN	9bdc6081-e6a7-46f4-9028-c08f3c7c2dca	1
1094104	phenazopyridine hydrochloride 200 MG Oral Tablet	SCD	9bdc6081-e6a7-46f4-9028-c08f3c7c2dca	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-122-03	52959012203	3 in 1 BOTTLE	Historical
52959-122-04	52959012204	4 in 1 BOTTLE	Historical
52959-122-06	52959012206	6 in 1 BOTTLE	Historical
52959-122-09	52959012209	9 in 1 BOTTLE	Historical
52959-122-10	52959012210	10 in 1 BOTTLE	Historical
52959-122-12	52959012212	12 in 1 BOTTLE	Historical
52959-122-15	52959012215	15 in 1 BOTTLE	Historical
52959-122-20	52959012220	20 in 1 BOTTLE	Historical
52959-122-30	52959012230	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phenazopyridine HCl Tablets, USP Rx Only	H.J. Harkins Company, Inc. \| Boca Pharmacal, Inc \| Cispharma, Inc	2011-10-12	HUMAN PRESCRIPTION DRUG LABEL	1