Dermisa

Product NDC: 68343-001
11-digit product format: 683430001
Labeler code: 68343
Product ID: 68343-001_71653743-e77e-90b0-e053-2995a90a1e98
Type: HUMAN OTC DRUG
Nonproprietary name: Hydroquinone Padimate O
Dosage form: CREAM
Route: TOPICAL
Labeler: Montani Cosmetics Inc
Application: part358A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2011-09-15
Marketing end: 0000-00-00
Substance: HYDROQUINONE; PADIMATE O
Active strength: 2 g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68343-001		I	Inactivated by FDA	2026-10-12
excluded package	package	68343-001	68343-001-01	I	Inactivated by FDA	2026-10-12
excluded package	package	68343-001	68343-001-02	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 1 · 57 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	68343-001-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68343-001-02	`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	68343-001-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68343-001-02	`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	68343-001-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68343-001-02	`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	68343-001-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68343-001-02	`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	68343-001-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68343-001-02	`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	68343-001-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68343-001-02	`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	68343-001-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68343-001-02	`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	68343-001-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68343-001-02	`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	68343-001-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68343-001-02	`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	68343-001-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68343-001-02	`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	68343-001-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68343-001-02	`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	68343-001-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68343-001-02	`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	68343-001-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68343-001-02	`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	68343-001-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68343-001-02	`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	68343-001-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68343-001-02	`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	68343-001-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68343-001-02	`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	68343-001-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68343-001-02	`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	68343-001-01	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68343-001-02	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68343-001-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68343-001-02	`8dfbde2a14a4…`	`c9ff85d89658…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
85490a6b-2306-6bf2-c51b-eb63537dc2da	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68343-001-01	2021-01-29	C162847	48780-1	ba0f9c33-37c8-a910-e053-dadaa90a0b85	Drug Facts
68343-001-02	2021-01-29	C162847	48780-1	ba0f9c33-37c8-a910-e053-dadaa90a0b85	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68343-001-01	DermisaSkin Fade	1 in 1 BOX	CREAM	1	5
68343-001-02	DermisaSkin Fade	1 in 1 BOX	CREAM	1	5
68343-001-25	DermisaSkin Fade	25 g in 1 TUBE	CREAM	25	5
68343-001-50	DermisaSkin Fade	50 g in 1 TUBE	CREAM	50	5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROQUINONE	ACTIVE INGREDIENT	XV74C1N1AE	DERMISA SKIN FADE (HYDROQUINONE PADIMATE O) CREAM [MONTANI COSMETICS INC]	3
PADIMATE O	ACTIVE INGREDIENT	Z11006CMUZ	DERMISA SKIN FADE (HYDROQUINONE PADIMATE O) CREAM [MONTANI COSMETICS INC]	3
HYDROQUINONE	ACTIVE MOIETY	XV74C1N1AE	DERMISA SKIN FADE (HYDROQUINONE PADIMATE O) CREAM [MONTANI COSMETICS INC]	3
PADIMATE O	ACTIVE MOIETY	Z11006CMUZ	DERMISA SKIN FADE (HYDROQUINONE PADIMATE O) CREAM [MONTANI COSMETICS INC]	3
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	DERMISA SKIN FADE (HYDROQUINONE PADIMATE O) CREAM [MONTANI COSMETICS INC]	3
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	DERMISA SKIN FADE (HYDROQUINONE PADIMATE O) CREAM [MONTANI COSMETICS INC]	3
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	DERMISA SKIN FADE (HYDROQUINONE PADIMATE O) CREAM [MONTANI COSMETICS INC]	3
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	DERMISA SKIN FADE (HYDROQUINONE PADIMATE O) CREAM [MONTANI COSMETICS INC]	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	DERMISA SKIN FADE (HYDROQUINONE PADIMATE O) CREAM [MONTANI COSMETICS INC]	3
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	DERMISA SKIN FADE (HYDROQUINONE PADIMATE O) CREAM [MONTANI COSMETICS INC]	3
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	DERMISA SKIN FADE (HYDROQUINONE PADIMATE O) CREAM [MONTANI COSMETICS INC]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DERMISA SKIN FADE (HYDROQUINONE PADIMATE O) CREAM [MONTANI COSMETICS INC]	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	DERMISA SKIN FADE (HYDROQUINONE PADIMATE O) CREAM [MONTANI COSMETICS INC]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DERMISA SKIN FADE (HYDROQUINONE PADIMATE O) CREAM [MONTANI COSMETICS INC]	3
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	DERMISA SKIN FADE (HYDROQUINONE PADIMATE O) CREAM [MONTANI COSMETICS INC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	DERMISA SKIN FADE (HYDROQUINONE PADIMATE O) CREAM [MONTANI COSMETICS INC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68343-001	DERMISA SKIN FADE (HYDROQUINONE PADIMATE O) CREAM [MONTANI COSMETICS INC]	5	Legacy NDC, 4 package rows	20180720_03fff226-a013-4a71-926e-5df3661be22e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
XV74C1N1AE	HYDROQUINONE	123-31-9	HYDROQUINONE
Z11006CMUZ	PADIMATE O	21245-02-3	PADIMATE O

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
153031	hydroquinone 2 % Topical Cream	PSN	03fff226-a013-4a71-926e-5df3661be22e	5
153031	hydroquinone 20 MG/ML Topical Cream	SCD	03fff226-a013-4a71-926e-5df3661be22e	5
153031	hydroquinone 2 % Topical Cream	SY	03fff226-a013-4a71-926e-5df3661be22e	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
68343-001-01	68343000101	1 in 1 BOX		Historical
68343-001-02	68343000102	1 in 1 BOX		Historical
68343-001-25	68343000125	25 g in 1 TUBE	25 g	Historical
68343-001-50	68343000150	50 g in 1 TUBE	50 g	Historical