CeraVe

Product NDC: 0187-2489
11-digit product format: 001872489
Labeler code: 0187
Product ID: 0187-2489_a150b8c0-a320-4adb-a43e-2e809a220e82
Type: HUMAN OTC DRUG
Nonproprietary name: dimethicone
Dosage form: CREAM
Route: TOPICAL
Labeler: Valeant Pharmaceuticals North America LLC
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-01-01
Marketing end: 0000-00-00
Substance: DIMETHICONE
Active strength: 10 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0187-2489		D	Discontinued by firm	2026-08-11
excluded package	package	0187-2489	0187-2489-25	D	Discontinued by firm	2026-08-11
excluded package	package	0187-2489	0187-2489-31	D	Discontinued by firm	2026-08-11

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 · 45 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	0187-2489-31	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0187-2489-25	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	0187-2489-31	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0187-2489-25	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	0187-2489-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0187-2489-25	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	0187-2489-31	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0187-2489-25	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	0187-2489-31	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0187-2489-25	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	0187-2489-31	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0187-2489-25	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	0187-2489-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0187-2489-25	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	0187-2489-31	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0187-2489-25	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	0187-2489-31	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0187-2489-25	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	0187-2489-31	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0187-2489-25	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	0187-2489-31	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0187-2489-25	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	0187-2489-31	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0187-2489-25	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	0187-2489-25	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0187-2489-31	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	0187-2489-25	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0187-2489-31	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0187-2489-31	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0187-2489-25	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0187-2489-25	2021-05-06	Drug Facts
0187-2489-31	2021-05-06	Drug Facts
0187-2489-25	2020-01-31	Drug Facts
0187-2489-31	2020-01-31	Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	CERAVE THERAPEUTIC HAND (DIMETHICONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	2
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	CERAVE THERAPEUTIC HAND (DIMETHICONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	2
ALUMINUM HYDROXIDE	INACTIVE INGREDIENT	5QB0T2IUN0	CERAVE THERAPEUTIC HAND (DIMETHICONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	2
CERAMIDE 1	INACTIVE INGREDIENT	5THT33P7X7	CERAVE THERAPEUTIC HAND (DIMETHICONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	2
CERAMIDE 3	INACTIVE INGREDIENT	4370DF050B	CERAVE THERAPEUTIC HAND (DIMETHICONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	2
CERAMIDE 6 II	INACTIVE INGREDIENT	F1X8L2B00J	CERAVE THERAPEUTIC HAND (DIMETHICONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	2
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)	INACTIVE INGREDIENT	035JKJ76MT	CERAVE THERAPEUTIC HAND (DIMETHICONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	2
CHOLESTEROL	INACTIVE INGREDIENT	97C5T2UQ7J	CERAVE THERAPEUTIC HAND (DIMETHICONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	2
CYCLOMETHICONE	INACTIVE INGREDIENT	NMQ347994Z	CERAVE THERAPEUTIC HAND (DIMETHICONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	2
HEXYL LAURATE	INACTIVE INGREDIENT	4CG9F9W01Q	CERAVE THERAPEUTIC HAND (DIMETHICONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	2
HYALURONIC ACID	INACTIVE INGREDIENT	S270N0TRQY	CERAVE THERAPEUTIC HAND (DIMETHICONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	2
MAGNESIUM HYDROXIDE	INACTIVE INGREDIENT	NBZ3QY004S	CERAVE THERAPEUTIC HAND (DIMETHICONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	2
NIACINAMIDE	INACTIVE INGREDIENT	25X51I8RD4	CERAVE THERAPEUTIC HAND (DIMETHICONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	2
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	CERAVE THERAPEUTIC HAND (DIMETHICONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	2
PHYTOSPHINGOSINE	INACTIVE INGREDIENT	GIN46U9Q2Q	CERAVE THERAPEUTIC HAND (DIMETHICONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	2
POLYGLYCERYL-4 ISOSTEARATE	INACTIVE INGREDIENT	820DPX33S7	CERAVE THERAPEUTIC HAND (DIMETHICONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	CERAVE THERAPEUTIC HAND (DIMETHICONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	CERAVE THERAPEUTIC HAND (DIMETHICONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	2
SODIUM LAUROYL LACTYLATE	INACTIVE INGREDIENT	7243K85WFO	CERAVE THERAPEUTIC HAND (DIMETHICONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	CERAVE THERAPEUTIC HAND (DIMETHICONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	CERAVE THERAPEUTIC HAND (DIMETHICONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	CERAVE THERAPEUTIC HAND (DIMETHICONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	2

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
92RU3N3Y1O	DIMETHICONE	9006-65-9	DIMETHICONE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Valeant Pharmaceuticals North America LLC \| Accupac, Inc	2015-02-20	HUMAN OTC DRUG LABEL	2

CeraVe

NDC auxiliary status#

Observed NDC auxiliary status history#

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#