Ferric Subsulfate

Product NDC: 59365-6065
11-digit product format: 593656065
Labeler code: 59365
Product ID: 59365-6065_d8d4fa24-4aef-4d37-9434-5901f439369e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ferric Subsulfate
Dosage form: SOLUTION
Route: TOPICAL
Labeler: CooperSurgical, Inc.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 1992-10-01
Marketing end: 0000-00-00
Substance: FERRIC SUBSULFATE
Active strength: 259 mg/g
Pharmacologic classes: Iron [CS],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	59365-6065		I	Inactivated by FDA		2026-08-17
excluded package	package	59365-6065	59365-6065-1	I	Inactivated by FDA		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 · 36 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	59365-6065-1	`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	59365-6065-1	`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	59365-6065-1	`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	59365-6065-1	`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	59365-6065-1	`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	59365-6065-1	`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	59365-6065-1	`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	59365-6065-1	`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	59365-6065-1	`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	59365-6065-1	`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	59365-6065-1	`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	59365-6065-1	`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	59365-6065-1	`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	59365-6065-1	`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	59365-6065-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	59365-6065-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	59365-6065-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	59365-6065-1	`bd6a592717d7…`	`303034d00443…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
04cdd491-d111-4bc2-9549-75c575e1bd4b	Product name	1	20200714
8390fb8b-6c75-416c-a9a1-70e8ed493b73	Product name	1	20200611
96a528e9-23e2-495f-81b9-ae87df2f7552	Product name	1	20191120
3df56c93-5837-4523-aac2-4b1ec48b9676	Product name	2	20160719
a883b7cc-d320-41d7-92ae-c873457ae641	Product name	1	20151116
bb23e78e-9e64-4037-a1c1-0e1d8762700e	Product name	1	20150325
ef06c001-572c-d95e-42f6-ee83da75673a	Product name	1	20140508
fd21f957-6863-d07b-5a35-250186878716	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59365-6065-1	2021-01-29	C162847	48780-1	ba0f9c33-5ea4-a910-e053-dadaa90a0b85	AstrinGyn

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59365-6065-0	Ferric Subsulfate	8 g in 1 VIAL, SINGLE-USE	SOLUTION	8		11
59365-6065-1	Ferric Subsulfate	12 in 1 CARTON	SOLUTION	12		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59365-6065-0	GM - Gram	59365-6065	4f54df4e-c757-4096-ae85-3e5000904338	1	2013-11-04
59365-6065-1	GM - Gram	59365-6065	501e7678-564d-4720-93d8-c8db9232bd4d	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FERRIC SUBSULFATE	ACTIVE INGREDIENT	3QJ8WS6V8H	FERRIC SUBSULFATE SOLUTION [COOPERSURGICAL, INC.]	9
FERRIC CATION	ACTIVE MOIETY	91O4LML611	FERRIC SUBSULFATE SOLUTION [COOPERSURGICAL, INC.]	9
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	FERRIC SUBSULFATE SOLUTION [COOPERSURGICAL, INC.]	9
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	FERRIC SUBSULFATE SOLUTION [COOPERSURGICAL, INC.]	9
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	FERRIC SUBSULFATE SOLUTION [COOPERSURGICAL, INC.]	9
WATER	INACTIVE INGREDIENT	059QF0KO0R	FERRIC SUBSULFATE SOLUTION [COOPERSURGICAL, INC.]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59365-6065	FERRIC SUBSULFATE SOLUTION [COOPERSURGICAL, INC.]	11	Legacy NDC, 2 package rows	20210318_e93bce8b-de3b-4477-be41-d361e68849c6.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3QJ8WS6V8H	FERRIC SUBSULFATE	1310-45-8	FERRIC SUBSULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
544860	ferric subsulfate 259 MG/GM Topical Solution	PSN	e93bce8b-de3b-4477-be41-d361e68849c6	11
544860	ferric subsulfate solution 259 MG/ML Topical Solution	SCD	e93bce8b-de3b-4477-be41-d361e68849c6	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59365-6065-0	59365606500	8 g in 1 VIAL, SINGLE-USE	8 g					Historical
59365-6065-1	59365606501	12 VIAL, SINGLE-USE in 1 CARTON (59365-6065-1) > 8 g in 1 VIAL, SINGLE-USE (59365-6065-0)		1992-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Leep RediKit	CooperSurgical, Inc.	2023-10-26	HUMAN PRESCRIPTION DRUG LABEL	5
AstrinGyn	CooperSurgical, Inc.	2016-05-25	HUMAN PRESCRIPTION DRUG LABEL	11