Remedy Skin Repair

Product NDC: 53329-161
11-digit product format: 533290161
Labeler code: 53329
Product ID: 53329-161_ebe22ef9-7535-5e78-e053-2a95a90a0d3b
Type: HUMAN OTC DRUG
Nonproprietary name: dimethicone
Dosage form: CREAM
Route: TOPICAL
Labeler: Medline Industries, LP
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2008-08-01
Marketing end: 2024-05-11
Substance: DIMETHICONE
Active strength: 2 g/100mL
Pharmacologic classes: Skin Barrier Activity [PE]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53329-161		D	Discontinued by firm	2026-10-12
excluded package	package	53329-161	53329-161-04	D	Discontinued by firm	2026-10-12
excluded package	package	53329-161	53329-161-13	D	Discontinued by firm	2026-10-12
excluded package	package	53329-161	53329-161-23	D	Discontinued by firm	2026-10-12
excluded package	package	53329-161	53329-161-96	D	Discontinued by firm	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 · 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	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	53329-161-23	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-161-96	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-161-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-161-13	`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	53329-161-23	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-161-96	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-161-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-161-13	`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	53329-161-23	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53329-161-96	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53329-161-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53329-161-13	`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	53329-161-23	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53329-161-96	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53329-161-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53329-161-13	`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	53329-161-23	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53329-161-96	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53329-161-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53329-161-13	`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	53329-161-23	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53329-161-96	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53329-161-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53329-161-13	`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	53329-161-23	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53329-161-96	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53329-161-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53329-161-13	`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	53329-161-23	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53329-161-96	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53329-161-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53329-161-13	`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	53329-161-23	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53329-161-96	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53329-161-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53329-161-13	`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	53329-161-23	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53329-161-96	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53329-161-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53329-161-13	`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	53329-161-23	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53329-161-96	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53329-161-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53329-161-13	`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	53329-161-23	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53329-161-96	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53329-161-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53329-161-13	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53329-161-04	ML - Milliliter	53329-161	69af78ff-8eea-495f-932c-eb3fc0be97a4	1	2012-07-24
53329-161-13	ML - Milliliter	53329-161	4212d312-b81d-4e58-aaa5-086eea021750	1	2012-07-24
53329-161-23	ML - Milliliter	53329-161	71c3ded0-08fa-42b8-b8d5-613bc5fdd6a4	1	2012-07-24
53329-161-96	ML - Milliliter	53329-161	a1126926-608c-444c-81a2-e072c2d74dfa	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
.ALPHA.-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
ACETYLCYSTEINE	INACTIVE INGREDIENT	WYQ7N0BPYC	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
ASCORBYL PALMITATE	INACTIVE INGREDIENT	QN83US2B0N	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
CANOLA OIL	INACTIVE INGREDIENT	331KBJ17RK	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
CHOLECALCIFEROL	INACTIVE INGREDIENT	1C6V77QF41	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
CORN OIL	INACTIVE INGREDIENT	8470G57WFM	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
DIMETHYL SULFONE	INACTIVE INGREDIENT	9H4PO4Z4FT	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
GLYCINE	INACTIVE INGREDIENT	TE7660XO1C	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
MANDARIN OIL	INACTIVE INGREDIENT	NJO720F72R	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
NIACINAMIDE	INACTIVE INGREDIENT	25X51I8RD4	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
OLIVE OIL	INACTIVE INGREDIENT	6UYK2W1W1E	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
ORANGE OIL	INACTIVE INGREDIENT	AKN3KSD11B	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
PROLINE	INACTIVE INGREDIENT	9DLQ4CIU6V	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
PYRIDOXINE HYDROCHLORIDE	INACTIVE INGREDIENT	68Y4CF58BV	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
TAURINE	INACTIVE INGREDIENT	1EQV5MLY3D	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
VANILLIN	INACTIVE INGREDIENT	CHI530446X	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]	2

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53329-161-04	53329016104	118 mL in 1 TUBE (53329-161-04)	118 ml	2008-08-01	0000-00-00	No	No	Current
53329-161-13	53329016113	59 mL in 1 TUBE (53329-161-13)	59 ml	2008-08-01	0000-00-00	No	No	Current
53329-161-23	53329016123	946 mL in 1 BOTTLE, PUMP (53329-161-23)	946 ml	2008-08-01	0000-00-00	No	No	Current
53329-161-96	53329016196	144 PACKET in 1 CARTON (53329-161-96) > 4 mL in 1 PACKET	144 packet	2008-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
161 Remedy with Olivamine Everyday Moisturizer	Medline Industries, LP	2022-10-25	HUMAN OTC DRUG LABEL	6