Remedy Skin Repair

Product NDC: 53329-140
11-digit product format: 533290140
Labeler code: 53329
Product ID: 53329-140_efcfafc0-8daf-3693-e053-2995a90a983f
Type: HUMAN OTC DRUG
Nonproprietary name: Dimethicone
Dosage form: CREAM
Route: TOPICAL
Labeler: Medline Industries, LP
Application: M016
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2010-03-01
Marketing end: 0000-00-00
Substance: DIMETHICONE
Active strength: 2 g/100mL
Pharmacologic classes: Skin Barrier Activity [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	53329-140		D	Discontinued by firm	2026-10-12
excluded package	package	53329-140	53329-140-04	D	Discontinued by firm	2026-10-12
excluded package	package	53329-140	53329-140-23	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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product	53329-140		I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53329-140	53329-140-23	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53329-140	53329-140-04	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`

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
7b19f89e-0a13-4d4e-a994-a46d39d008b9	Product name	1	20251120
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
13c3e0af-2da2-8aec-9e17-1afd680d80c2	Product name	8	20221116
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
5e18e798-5614-cf5c-0185-38b1cb77a093	Product name	2	20160822
f46c867f-cde5-4f14-a7c1-18ae3a6efd1c	Product name	1	20160303
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
53329-140-04	2021-01-13	140 Remedy Olivamine Skin Repair Cream (unscented)
53329-140-04	2021-01-13	140 Remedy Olivamine Skin Repair Cream (unscented)
53329-140-23	2021-01-13	140 Remedy Olivamine Skin Repair Cream (unscented)
53329-140-23	2021-01-13	140 Remedy Olivamine Skin Repair Cream (unscented)
53329-140-04	2020-09-27	140 Remedy Olivamine Skin Repair Cream (unscented)
53329-140-04	2020-09-27	140 Remedy Olivamine Skin Repair Cream (unscented)
53329-140-23	2020-09-27	140 Remedy Olivamine Skin Repair Cream (unscented)
53329-140-23	2020-09-27	140 Remedy Olivamine Skin Repair Cream (unscented)
53329-140-04	2020-09-25	140 Remedy Olivamine Skin Repair Cream (unscented)
53329-140-04	2020-09-25	140 Remedy Olivamine Skin Repair Cream (unscented)
53329-140-23	2020-09-25	140 Remedy Olivamine Skin Repair Cream (unscented)
53329-140-23	2020-09-25	140 Remedy Olivamine Skin Repair Cream (unscented)
53329-140-04	2020-07-22	140 Remedy Olivamine Skin Repair Cream (unscented)
53329-140-04	2020-07-22	140 Remedy Olivamine Skin Repair Cream (unscented)
53329-140-23	2020-07-22	140 Remedy Olivamine Skin Repair Cream (unscented)
53329-140-23	2020-07-22	140 Remedy Olivamine Skin Repair Cream (unscented)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53329-140-04	Remedy Skin Repair	118 mL in 1 TUBE	CREAM	118		13
53329-140-23	Remedy Skin Repair	946 mL in 1 BOTTLE, PUMP	CREAM	946		13

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-140	REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, LP]	11	Legacy NDC, 2 package rows	20231025_ab02322c-5862-4734-810e-7fb951c8d6a5.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 6 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mederma PM	DIMETHICONE	PMI Branded Pharmaceuticals, Inc.	26737285-f6ae-47eb-9019-33f1cfce3029	2026-07-15	Warnings	Exact identifier application number: M016
MEDERMA STRETCH MARKS THERAPY	DIMETHICONE	L. Perrigo Company	e9366775-e85b-4403-a2c5-12d9fb3cc3fa	2026-07-15	Warnings	Exact identifier application number: M016
Remedy Barrier Cream Cloths Fragrance Free	DIMETHICONE	Medline Industries, LP	00e0cd4a-6049-408a-ab3f-9edf97e6438a	2026-07-14	Warnings	Exact identifier application number: M016
Cruex Petroleum Jelly	WHITE PETROLATUM	MKJ BRANDS LLC	3e61191a-e0fa-3477-e063-6294a90a7d19	2026-07-14	Warnings	Exact identifier application number: M016
Cruex Petroleum Jelly	WHITE PETROLATUM	MKJ BRANDS LLC	459a90b8-7d52-ef70-e063-6394a90ac1d0	2026-07-14	Warnings	Exact identifier application number: M016
Mederma for Kids	ALLANTOIN	L. Perrigo Company	ed4ff435-9819-46d3-9375-914712943f77	2026-07-14	Warnings	Exact identifier application number: M016
Baby 3-in-1 Diaper Rash	BABY 3-IN-1 DIAPER RASH	Walgreens	5632dde2-f59d-3a45-e063-6394a90a1a24	2026-07-09	Warnings	Exact identifier application number: M016
Drs. DIAPER RASH MAXIMUM STRENGTH	ZINC OXIDE	OL PHARMA TECH, LLC Drs PHARMACY	161ba174-1b13-83cd-e063-6394a90af19c	2026-07-09	Warnings	Exact identifier application number: M016
Drs. Hydrocortisone Aloe Vera	HYDROCORTISONE	OL PHARMA TECH,LLC	0df06415-5d32-7ef8-e063-6294a90a6e5a	2026-07-09	Warnings	Exact identifier application number: M016
SOHEJU Nail Repairs Patches	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	560089ff-3361-90b7-e063-6294a90ada42	2026-07-09	Warnings	Exact identifier application number: M016
Bee Venom Psoriasis Wart Caring Cream	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	563a423c-e9dd-1cab-e063-6294a90a8c6a	2026-07-09	Warnings	Exact identifier application number: M016
Skin Protectant with Lanolin	LANOLIN	McKesson Medical-Surgical Inc.	46df52c8-0cbf-213e-e054-00144ff88e88	2026-07-08	Warnings	Exact identifier application number: M016
Skin Protectant with Lanolin	LANOLIN	McKesson	5abe1b34-f71b-2a90-e053-2991aa0aded6	2026-07-08	Warnings	Exact identifier application number: M016
Walgreens Baby Healing Balm	PETROLATUM	Walgreens	561c1e1e-e896-d6e9-e063-6394a90ac0e7	2026-07-08	Warnings	Exact identifier application number: M016
AD Overnight Healing	AD OVERNIGHT HEALING	WellSpring Pharmaceutical Corporation	57c29db6-da0c-4b28-86c0-6ac1b7122428	2026-07-07	Warnings	Exact identifier application number: M016
EczeNourish Eczema and Psoriasis Soothing Oat	COLLOIDAL OATMEAL	Vanguard Soap, LLC	55f7137f-c5a5-f2ce-e063-6394a90a5280	2026-07-07	Warnings	Exact identifier application number: M016
FDS intimate Whole Body Medicated Chafing	FDS INTIMATE WHOLE BODY MEDICATED CHAFING	WellSpring Pharmaceutical Corporation	ef01fcd8-2fe4-4076-a4d4-e730a5c2b31c	2026-07-07	Warnings	Exact identifier application number: M016
AD First Aid Multipurpose	AD FIRST AID MULTIPURPOSE	WellSpring Pharmaceutical Corporation	999989d8-21c2-4380-b4c1-e5421189f6ed	2026-07-07	Warnings	Exact identifier application number: M016
AD Anti-Chafing	AD ANTI-CHAFING	WellSpring Pharmaceutical Corporation	d272ab4a-eb18-4f64-b925-fccf637dbb02	2026-07-06	Warnings	Exact identifier application number: M016
ECZEMA NOURISH MEDICATED CLEANSING BAR	COLLOIDAL OATMEAL SKIN PROTECTANT	Vanguard Soap, LLC	55f865dc-d88e-fe2f-e063-6294a90aa7d3	2026-07-06	Warnings	Exact identifier application number: M016

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309917	dimethicone 1.5 % Topical Cream	PSN	ab02322c-5862-4734-810e-7fb951c8d6a5	13
309917	dimethicone 15 MG/ML Topical Cream	SCD	ab02322c-5862-4734-810e-7fb951c8d6a5	13
309917	dimethicone 1.5 % Topical Cream	SY	ab02322c-5862-4734-810e-7fb951c8d6a5	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53329-140-04	53329014004	118 mL in 1 TUBE (53329-140-04)	118 ml	2010-03-01	0000-00-00	No	No	Current
53329-140-23	53329014023	946 mL in 1 BOTTLE, PUMP (53329-140-23)	946 ml	2017-02-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
140 Remedy Olivamine Skin Repair Cream (unscented)	Medline Industries, LP	2025-10-28	HUMAN OTC DRUG LABEL	13