Monsels Solution

Product NDC: 48992-001
Requested package NDC: 48992-001-01
11-digit product format: 489920001
Labeler code: 48992
Product ID: 48992-001_cf32cbad-332c-2546-e053-2a95a90a5b30
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ferric Subsulfate
Dosage form: PASTE
Route: TOPICAL
Labeler: Gynex Corporation
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2020-03-13
Marketing end: 0000-00-00
Substance: FERRIC SUBSULFATE
Active strength: 210 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	48992-001	48992-001-01	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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
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
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
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
48992-001-01	2023-01-30	C162847	48780-1	f386c649-e1f4-0266-e053-dadaa90a7c1a	170ce265-2951-47a6-8f56-a27cc39cbdf8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
48992-001-01	Monsels Solution	14 g in 1 VIAL, SINGLE-DOSE	PASTE	14		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
48992-001	MONSELS SOLUTION (FERRIC SUBSULFATE) PASTE [GYNEX CORPORATION]	2	Legacy NDC, 1 package rows	20211027_170ce265-2951-47a6-8f56-a27cc39cbdf8.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
831162	Monsel's ferric subsulfate 20 % - 22 % Topical Solution	PSN	170ce265-2951-47a6-8f56-a27cc39cbdf8	2
831162	ferric subsulfate solution 220 MG/ML Topical Solution	SCD	170ce265-2951-47a6-8f56-a27cc39cbdf8	2
831162	Monsel's 20 % - 22 % Topical Solution	SY	170ce265-2951-47a6-8f56-a27cc39cbdf8	2
831162	Monsel's 20 % Topical Solution	SY	170ce265-2951-47a6-8f56-a27cc39cbdf8	2
831162	Monsel's 22 % Topical Solution	SY	170ce265-2951-47a6-8f56-a27cc39cbdf8	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
48992-001-01	48992000101	14 g in 1 VIAL, SINGLE-DOSE (48992-001-01)	14 g	2020-03-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Monsels Solution - Gynex Corporation \| Diversified Chemical Products, Inc.	Gynex Corporation \| Diversified Chemical Products, Inc.	2021-10-25	HUMAN PRESCRIPTION DRUG LABEL	2