Dermadrox

Product NDC: 54162-221
11-digit product format: 541620221
Labeler code: 54162
Product ID: 54162-221_e9a97d88-96fc-4ea0-9482-524aac47716f
Type: HUMAN OTC DRUG
Nonproprietary name: Aluminum Hydroxide
Dosage form: OINTMENT
Route: TOPICAL
Labeler: GERITREX LLC
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2015-07-31
Marketing end: 0000-00-00
Substance: ALUMINUM HYDROXIDE
Active strength: 1 g/113g
NDC exclude flag: No
Listing certified through: 2019-12-31
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	54162-221		I	Inactivated by FDA	2026-08-10
excluded product	product	54162-221		I	Inactivated by FDA	2026-08-10
excluded package	package	54162-221	54162-221-04	I	Inactivated by FDA	2026-08-10
excluded package	package	54162-221	54162-221-01	I	Inactivated by FDA	2026-08-10

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 · 84 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	54162-221-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54162-221-04	`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	54162-221-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54162-221-04	`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	54162-221-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54162-221-04	`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	54162-221-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54162-221-04	`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	54162-221-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54162-221-04	`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	54162-221-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54162-221-04	`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	54162-221-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54162-221-04	`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	54162-221-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54162-221-04	`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	54162-221-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54162-221-04	`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	54162-221-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54162-221-04	`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	54162-221-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54162-221-04	`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	54162-221-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54162-221-04	`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	54162-221-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	54162-221-04	`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	54162-221-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	54162-221-04	`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	54162-221-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	54162-221-04	`1332a3947898…`	`d4bfe170f9cd…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54162-221-01	2020-01-31	C162847	48780-1	9d75b9d0-612a-f424-e053-dadaa90a57ce	Dermadrox Ointment
54162-221-04	2020-01-31	C162847	48780-1	9d75b9d0-e587-f424-e053-dadaa90a57ce	Dermadrox Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54162-221-01	Dermadrox	113 g in 1 TUBE	OINTMENT	113		3
54162-221-04	Dermadrox	113 g in 1 JAR	OINTMENT	113		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54162-221-01	GM - Gram	54162-221	a6eef10b-e111-48a4-ba7d-54911ab23329	1	2013-03-03
54162-221-04	GM - Gram	54162-221	34c84eb2-751d-45cf-a5c5-18f6a1cf0648	1	2013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALUMINUM HYDROXIDE	ACTIVE INGREDIENT	5QB0T2IUN0	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	2
ALUMINUM HYDROXIDE	ACTIVE MOIETY	5QB0T2IUN0	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	2
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	2
CITRIC ACID ACETATE	INACTIVE INGREDIENT	DSO12WL7AU	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	2
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	2
LANOLIN ALCOHOLS	INACTIVE INGREDIENT	884C3FA9HE	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	2
MAGNESIUM HYDROXIDE	INACTIVE INGREDIENT	NBZ3QY004S	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	2
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	2
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	2
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	2
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	2
VITAMIN A	INACTIVE INGREDIENT	81G40H8B0T	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	2
VITAMIN D	INACTIVE INGREDIENT	9VU1KI44GP	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	2
ZINC CHLORIDE	INACTIVE INGREDIENT	86Q357L16B	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	2
ALUMINUM HYDROXIDE	ACTIVE INGREDIENT	5QB0T2IUN0	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	1
ALUMINUM HYDROXIDE	ACTIVE MOIETY	5QB0T2IUN0	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	1
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	1
CITRIC ACID ACETATE	INACTIVE INGREDIENT	DSO12WL7AU	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	1
LANOLIN ALCOHOLS	INACTIVE INGREDIENT	884C3FA9HE	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	1
MAGNESIUM HYDROXIDE	INACTIVE INGREDIENT	NBZ3QY004S	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	1
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	1
VITAMIN A	INACTIVE INGREDIENT	81G40H8B0T	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	1
VITAMIN D	INACTIVE INGREDIENT	9VU1KI44GP	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	1
ZINC CHLORIDE	INACTIVE INGREDIENT	86Q357L16B	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54162-221	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX LLC]	3	Legacy NDC, 1 package rows	20161103_dcf0aa6c-5fe7-46e3-a418-c79ecaca074c.zip
54162-221	DERMADROX (ALUMINUM HYDROXIDE) OINTMENT [GERITREX LLC]	3	Legacy NDC, 1 package rows	20170828_fa0b70c8-50e0-4184-9795-c17739c46630.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5QB0T2IUN0	ALUMINUM HYDROXIDE	21645-51-2	ALUMINUM HYDROXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1368022	aluminum hydroxide 1.2 % Topical Ointment	PSN	dcf0aa6c-5fe7-46e3-a418-c79ecaca074c	3
1368022	aluminum hydroxide 1.2 % Topical Ointment	PSN	fa0b70c8-50e0-4184-9795-c17739c46630	3
1368022	aluminum hydroxide 0.012 MG/MG Topical Ointment	SCD	dcf0aa6c-5fe7-46e3-a418-c79ecaca074c	3
1368022	aluminum hydroxide 0.012 MG/MG Topical Ointment	SCD	fa0b70c8-50e0-4184-9795-c17739c46630	3
1368022	aluminum hydroxide 1.2 % Topical Ointment	SY	dcf0aa6c-5fe7-46e3-a418-c79ecaca074c	3
1368022	aluminum hydroxide 1.2 % Topical Ointment	SY	fa0b70c8-50e0-4184-9795-c17739c46630	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
54162-221-01	54162022101	113 g in 1 TUBE	113 g	Historical
54162-221-04	54162022104	113 g in 1 JAR	113 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dermadrox Ointment	GERITREX LLC	2017-08-28	HUMAN OTC DRUG LABEL	3
Dermadrox Ointment	GERITREX LLC	2016-10-20	HUMAN OTC DRUG LABEL	3