AMBI Fade

Product NDC: 0187-5479
11-digit product format: 001875479
Labeler code: 0187
Product ID: 0187-5479_2e335de0-1593-4abe-94f0-26b492c83fb6
Type: HUMAN OTC DRUG
Nonproprietary name: Hydroquinone and Octinoxate
Dosage form: CREAM
Route: TOPICAL
Labeler: Valeant Pharmaceuticals North America LLC
Application: part358A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2014-02-04
Marketing end: 0000-00-00
Substance: HYDROQUINONE; OCTINOXATE
Active strength: 20 mg/g; mg/g
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	0187-5479		D	Discontinued by firm	2026-10-21
excluded package	package	0187-5479	0187-5479-02	D	Discontinued by firm	2026-10-21
excluded package	package	0187-5479	0187-5479-30	D	Discontinued by firm	2026-10-21
excluded package	package	0187-5479	0187-5479-99	D	Discontinued by firm	2026-10-21

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 · 60 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0187-5479-99	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0187-5479-02	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0187-5479-30	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0187-5479-99	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0187-5479-02	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0187-5479-30	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0187-5479-99	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0187-5479-02	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0187-5479-30	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0187-5479-99	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0187-5479-02	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0187-5479-30	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0187-5479-99	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0187-5479-02	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0187-5479-30	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0187-5479-99	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0187-5479-02	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0187-5479-30	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0187-5479-99	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0187-5479-02	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0187-5479-30	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0187-5479-99	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0187-5479-02	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0187-5479-30	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0187-5479-99	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0187-5479-02	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0187-5479-30	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0187-5479-99	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0187-5479-02	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0187-5479-30	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0187-5479-99	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0187-5479-02	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0187-5479-30	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0187-5479-99	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0187-5479-02	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0187-5479-30	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0187-5479-30	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0187-5479-99	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0187-5479-02	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0187-5479-30	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0187-5479-99	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0187-5479-02	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0187-5479-30	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0187-5479-99	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0187-5479-02	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0187-5479-02	2021-05-12	AMBI ® Fade Cream - Normal Skin
0187-5479-30	2021-05-12	AMBI ® Fade Cream - Normal Skin
0187-5479-99	2021-05-12	AMBI ® Fade Cream - Normal Skin
0187-5479-02	2019-11-27	AMBI ® Fade Cream - Normal Skin
0187-5479-30	2019-11-27	AMBI ® Fade Cream - Normal Skin
0187-5479-99	2019-11-27	AMBI ® Fade Cream - Normal Skin

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Hydroquinone	ACTIVE INGREDIENT	XV74C1N1AE	AMBI FADE NORMAL SKIN (HYDROQUINONE AND OCTINOXATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	AMBI FADE NORMAL SKIN (HYDROQUINONE AND OCTINOXATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Hydroquinone	ACTIVE MOIETY	XV74C1N1AE	AMBI FADE NORMAL SKIN (HYDROQUINONE AND OCTINOXATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Octinoxate	ACTIVE MOIETY	4Y5P7MUD51	AMBI FADE NORMAL SKIN (HYDROQUINONE AND OCTINOXATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
.Alpha.-Tocopherol Acetate	INACTIVE INGREDIENT	9E8X80D2L0	AMBI FADE NORMAL SKIN (HYDROQUINONE AND OCTINOXATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Betaine	INACTIVE INGREDIENT	3SCV180C9W	AMBI FADE NORMAL SKIN (HYDROQUINONE AND OCTINOXATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Butylene Glycol	INACTIVE INGREDIENT	3XUS85K0RA	AMBI FADE NORMAL SKIN (HYDROQUINONE AND OCTINOXATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Cetyl Alcohol	INACTIVE INGREDIENT	936JST6JCN	AMBI FADE NORMAL SKIN (HYDROQUINONE AND OCTINOXATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Cyclomethicone 5	INACTIVE INGREDIENT	0THT5PCI0R	AMBI FADE NORMAL SKIN (HYDROQUINONE AND OCTINOXATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	AMBI FADE NORMAL SKIN (HYDROQUINONE AND OCTINOXATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Ethylparaben	INACTIVE INGREDIENT	14255EXE39	AMBI FADE NORMAL SKIN (HYDROQUINONE AND OCTINOXATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	AMBI FADE NORMAL SKIN (HYDROQUINONE AND OCTINOXATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Glyceryl Monostearate	INACTIVE INGREDIENT	230OU9XXE4	AMBI FADE NORMAL SKIN (HYDROQUINONE AND OCTINOXATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Hydroxyethyl Urea	INACTIVE INGREDIENT	MBQ7DDQ7AR	AMBI FADE NORMAL SKIN (HYDROQUINONE AND OCTINOXATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Isopropyl Myristate	INACTIVE INGREDIENT	0RE8K4LNJS	AMBI FADE NORMAL SKIN (HYDROQUINONE AND OCTINOXATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Lactic Acid	INACTIVE INGREDIENT	33X04XA5AT	AMBI FADE NORMAL SKIN (HYDROQUINONE AND OCTINOXATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	AMBI FADE NORMAL SKIN (HYDROQUINONE AND OCTINOXATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
PEG-100 Stearate	INACTIVE INGREDIENT	YD01N1999R	AMBI FADE NORMAL SKIN (HYDROQUINONE AND OCTINOXATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Pentaerythritol Tetrakis(3-(3,5-Di-Tert-Butyl-4-Hydroxyphenyl)Propionate)	INACTIVE INGREDIENT	255PIF62MS	AMBI FADE NORMAL SKIN (HYDROQUINONE AND OCTINOXATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Potassium Cetyl Phosphate	INACTIVE INGREDIENT	03KCY6P7UT	AMBI FADE NORMAL SKIN (HYDROQUINONE AND OCTINOXATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	AMBI FADE NORMAL SKIN (HYDROQUINONE AND OCTINOXATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Sodium Ascorbyl Phosphate	INACTIVE INGREDIENT	836SJG51DR	AMBI FADE NORMAL SKIN (HYDROQUINONE AND OCTINOXATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Sodium Metabisulfite	INACTIVE INGREDIENT	4VON5FNS3C	AMBI FADE NORMAL SKIN (HYDROQUINONE AND OCTINOXATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Soybean	INACTIVE INGREDIENT	L7HT8F1ZOD	AMBI FADE NORMAL SKIN (HYDROQUINONE AND OCTINOXATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	AMBI FADE NORMAL SKIN (HYDROQUINONE AND OCTINOXATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	AMBI FADE NORMAL SKIN (HYDROQUINONE AND OCTINOXATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
XV74C1N1AE	HYDROQUINONE	123-31-9	HYDROQUINONE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AMBI ® Fade Cream - Normal Skin	Valeant Pharmaceuticals North America LLC \| Accupac, Inc.	2014-02-03	HUMAN OTC DRUG LABEL	1

AMBI Fade

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#