Sunmark Urinary Pain Relief Maximum Strength

Product NDC: 49348-941
11-digit product format: 493480941
Labeler code: 49348
Product ID: 49348-941_8b917912-878e-433e-a228-24b93bc60d60
Type: HUMAN OTC DRUG
Nonproprietary name: PHENAZOPYRIDINE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: McKesson
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2010-11-18
Marketing end: 0000-00-00
Substance: PHENAZOPYRIDINE HYDROCHLORIDE
Active strength: 98 mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	49348-941		I	Inactivated by FDA		2026-10-15
excluded package	package	49348-941	49348-941-01	I	Inactivated by FDA		2026-10-15

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 · 30 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	49348-941-01	`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	49348-941-01	`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	49348-941-01	`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	49348-941-01	`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	49348-941-01	`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	49348-941-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49348-941-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49348-941-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49348-941-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49348-941-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49348-941-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49348-941-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	49348-941-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	49348-941-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	49348-941-01	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49348-941-01	2023-01-30	C162847	48780-1	f386c64a-0dcc-0266-e053-dadaa90a7c1a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49348-941-01	Sunmark Urinary Pain Relief Maximum Strength	1 in 1 CARTON	TABLET	1		6
49348-941-02	Sunmark Urinary Pain Relief Maximum Strength	12 in 1 BLISTER PACK	TABLET	12		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49348-941-01	EA - Each	49348-941	b0f4efe2-281c-430c-abb6-3cd393b22b16	1	2022-06-06
49348-941-02	EA - Each	49348-941	46f92040-f39b-4580-a3e4-baf6ee672315	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENAZOPYRIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	0EWG668W17	SUNMARK URINARY PAIN RELIEF MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [MCKESSON]	1
PHENAZOPYRIDINE	ACTIVE MOIETY	K2J09EMJ52	SUNMARK URINARY PAIN RELIEF MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [MCKESSON]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	SUNMARK URINARY PAIN RELIEF MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [MCKESSON]	1
MAGNESIUM SILICATE	INACTIVE INGREDIENT	9B9691B2N9	SUNMARK URINARY PAIN RELIEF MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [MCKESSON]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SUNMARK URINARY PAIN RELIEF MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [MCKESSON]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49348-941	SUNMARK URINARY PAIN RELIEF MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [MCKESSON]	6	Legacy NDC, 2 package rows	20201224_c59cb31e-0e67-4cfa-8640-3304ccf6c4c5.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
1094357	phenazopyridine HCl 97.5 MG Oral Tablet	PSN	c59cb31e-0e67-4cfa-8640-3304ccf6c4c5	6
1094357	phenazopyridine hydrochloride 97.5 MG Oral Tablet	SCD	c59cb31e-0e67-4cfa-8640-3304ccf6c4c5	6
1094357	phenazopyridine HCl 97.5 MG Oral Tablet	PSN	6f24b86c-ac61-4c4b-a7ba-86f875dd4d3e	2
1094357	phenazopyridine hydrochloride 97.5 MG Oral Tablet	SCD	6f24b86c-ac61-4c4b-a7ba-86f875dd4d3e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49348-941-01	49348094101	1 BLISTER PACK in 1 CARTON (49348-941-01) > 12 TABLET in 1 BLISTER PACK (49348-941-02)	1 blister pack	2010-11-18	0000-00-00	No	No	Current
49348-941-02	49348094102	12 in 1 BLISTER PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Bryant Ranch Prepack	2021-12-28	HUMAN OTC DRUG LABEL	2
Drug Facts	McKesson \| Reese Pharmaceutical Co \| Pharbest	2020-12-22	HUMAN OTC DRUG LABEL	6