GRx Dyne

Product NDC: 54162-269
11-digit product format: 541620269
Labeler code: 54162
Product ID: 54162-269_75ffc2d3-b014-4e28-a7ae-76b61646f8e1
Type: HUMAN OTC DRUG
Nonproprietary name: Povidone Iodine
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Geritrex Corp.
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2012-05-21
Marketing end: 0000-00-00
Substance: POVIDONE-IODINE
Active strength: 10 mL/100mL
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	54162-269		I	Inactivated by FDA	2026-10-12
excluded product	product	54162-269		I	Inactivated by FDA	2026-10-12
excluded package	package	54162-269	54162-269-04	I	Inactivated by FDA	2026-10-12
excluded package	package	54162-269	54162-269-16	I	Inactivated by FDA	2026-10-12

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 2 · 88 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 product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54162-269-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54162-269-16	`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 product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54162-269-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54162-269-16	`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 product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54162-269-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54162-269-16	`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 product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54162-269-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54162-269-16	`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 product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54162-269-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54162-269-16	`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 product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54162-269-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54162-269-16	`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 product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54162-269-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54162-269-16	`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 product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54162-269-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54162-269-16	`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 product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54162-269-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54162-269-16	`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 product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54162-269-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54162-269-16	`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 product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54162-269-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54162-269-16	`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 product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54162-269-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54162-269-16	`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 product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	54162-269-04	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	54162-269-16	`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 product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	54162-269-04	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	54162-269-16	`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 product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	54162-269-04	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	54162-269-16	`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
54162-269-04	2019-11-13	C162847	48780-1	97449f38-c7bb-f6ea-e053-dbdaa90aa703	GRx Dyne Solution
54162-269-16	2019-11-13	C162847	48780-1	97449f38-cb7e-f6ea-e053-dbdaa90aa703	GRx Dyne Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54162-269-04	GRx Dyne	118 mL in 1 BOTTLE, PLASTIC	SOLUTION	118		1
54162-269-16	GRx Dyne	472 mL in 1 BOTTLE, PLASTIC	SOLUTION	472		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54162-269-04	ML - Milliliter	54162-269	567af7a7-e598-4bcb-8e6a-bc69051c4950	1	2013-02-13
54162-269-16	ML - Milliliter	54162-269	ff779f18-4f98-427f-8f19-9f185c1ee11c	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
POVIDONE-IODINE	ACTIVE INGREDIENT	85H0HZU99M	GRX DYNE (POVIDONE IODINE) SOLUTION [GERITREX CORP.]	1
POVIDONE-IODINE	ACTIVE INGREDIENT	85H0HZU99M	GRX DYNE (POVIDONE IODINE) SOLUTION [GERITREX CORP.]	1
POVIDONE-IODINE	ACTIVE MOIETY	85H0HZU99M	GRX DYNE (POVIDONE IODINE) SOLUTION [GERITREX CORP.]	1
POVIDONE-IODINE	ACTIVE MOIETY	85H0HZU99M	GRX DYNE (POVIDONE IODINE) SOLUTION [GERITREX CORP.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	GRX DYNE (POVIDONE IODINE) SOLUTION [GERITREX CORP.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	GRX DYNE (POVIDONE IODINE) SOLUTION [GERITREX CORP.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	GRX DYNE (POVIDONE IODINE) SOLUTION [GERITREX CORP.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	GRX DYNE (POVIDONE IODINE) SOLUTION [GERITREX CORP.]	1
NONOXYNOL-10	INACTIVE INGREDIENT	K7O76887AP	GRX DYNE (POVIDONE IODINE) SOLUTION [GERITREX CORP.]	1
NONOXYNOL-10	INACTIVE INGREDIENT	K7O76887AP	GRX DYNE (POVIDONE IODINE) SOLUTION [GERITREX CORP.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	GRX DYNE (POVIDONE IODINE) SOLUTION [GERITREX CORP.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	GRX DYNE (POVIDONE IODINE) SOLUTION [GERITREX CORP.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	GRX DYNE (POVIDONE IODINE) SOLUTION [GERITREX CORP.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	GRX DYNE (POVIDONE IODINE) SOLUTION [GERITREX CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54162-269	GRX DYNE (POVIDONE IODINE) SOLUTION [GERITREX CORP.]	1	Legacy NDC, 1 package rows	20120517_40091a7b-f107-44bf-9bf0-f58a8cafda83.zip
54162-269	GRX DYNE (POVIDONE IODINE) SOLUTION [GERITREX CORP.]	1	Legacy NDC, 1 package rows	20120522_80ebc348-b7c9-4d99-8c3b-2a79fef08902.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
85H0HZU99M	POVIDONE-IODINE	25655-41-8	POVIDONE-IODINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312564	povidone-iodine 10 % Topical Solution	PSN	40091a7b-f107-44bf-9bf0-f58a8cafda83	1
312564	povidone-iodine 10 % Topical Solution	PSN	80ebc348-b7c9-4d99-8c3b-2a79fef08902	1
312564	povidone-iodine 100 MG/ML Topical Solution	SCD	40091a7b-f107-44bf-9bf0-f58a8cafda83	1
312564	povidone-iodine 100 MG/ML Topical Solution	SCD	80ebc348-b7c9-4d99-8c3b-2a79fef08902	1
312564	povidone-iodine 10 % (titratable iodine 1 % ) Topical Solution	SY	40091a7b-f107-44bf-9bf0-f58a8cafda83	1
312564	povidone-iodine 10 % (titratable iodine 1 % ) Topical Solution	SY	80ebc348-b7c9-4d99-8c3b-2a79fef08902	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
54162-269-04	54162026904	118 mL in 1 BOTTLE, PLASTIC	118 ml	Historical
54162-269-16	54162026916	472 mL in 1 BOTTLE, PLASTIC	472 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GRx Dyne Solution	Geritrex Corp.	2012-05-21	HUMAN OTC DRUG LABEL	1
GRx Dyne Solution	Geritrex Corp.	2012-05-16	HUMAN OTC DRUG LABEL	1