Medline Remedy Phytoplex Skin Repair

Product NDC: 53329-995
11-digit product format: 533290995
Labeler code: 53329
Product ID: 53329-995_efe1a76d-ef6c-37f6-e053-2995a90a9538
Type: HUMAN OTC DRUG
Nonproprietary name: Dimeticone
Dosage form: CREAM
Route: TOPICAL
Labeler: Medline Industries, LP
Application: M016
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2019-11-01
Marketing end: 0000-00-00
Substance: DIMETHICONE
Active strength: 5 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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53329-995		D	Discontinued by firm	2026-10-15
excluded package	package	53329-995	53329-995-04	D	Discontinued by firm	2026-10-15
excluded package	package	53329-995	53329-995-13	D	Discontinued by firm	2026-10-15
excluded package	package	53329-995	53329-995-23	D	Discontinued by firm	2026-10-15
excluded package	package	53329-995	53329-995-84	D	Discontinued by firm	2026-10-15

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 · 10 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	53329-995-23	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-995-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-995-84	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-995-04	`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	53329-995-23	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-995-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-995-84	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-995-04	`f5e01cc5f278…`	`a2eaf40c39c3…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-995	MEDLINE REMEDY PHYTOPLEX SKIN REPAIR (DIMETICONE) CREAM [MEDLINE INDUSTRIES, LP]	7	Legacy NDC	20240514_99474981-9542-2e44-e053-2995a90ae191.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 57 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PETROLEUM	WHITE PETROLATUM	VIVE HEALTH LLC	24ae3875-1c86-c7ba-e063-6394a90a6729	2024-10-17	Warnings	Exact identifier application number: M016
Meijer Skin Relieving Moisturizing	DIMETHICONE	MEIJER DISTRIBUTION, INC	8e5be6b3-87e7-d958-e053-2a95a90a6961	2024-10-16	Warnings	Exact identifier application number: M016
GenRx Daily Defense Skin Repairing	DIMETHICONE	PureTek Corporation	7d2827fd-b40f-454b-bb60-54d77823b18c	2024-10-16	Warnings	Exact identifier application number: M016
Equate Daily Moisturizing Dimethicone Skin Protectant	DIMETHICONE	Walmart Stores Inc.	8fda01f7-a52a-4a63-98ac-b32cb47947f3	2024-10-16	Warnings	Exact identifier application number: M016
Hill Country Essentials	DIMETHICONE	H.E.B	c51d8647-8af6-473a-b989-dfa6bfdc368d	2024-10-15	Warnings	Exact identifier application number: M016
UNIVERSAL PURE PETROLEUM COCOA BUTTER SCENTED	WHITE PETROLEUM	Universal Distribution Center LLC	649e571f-0cd6-41e4-b31f-c818f94fb01d	2024-10-15	Warnings	Exact identifier application number: M016
WALGREENS ECZEMA	COLLOIDAL OATMEAL	WALGREEN COMPANY	fc502963-4cb6-5ce5-e053-6394a90a58c3	2024-10-14	Warnings	Exact identifier application number: M016
Target Up and Up Daily Moisturizing	DIMETHICONE	TARGET CORPORATION	f118e0eb-1e66-50ab-e053-2995a90a2cb9	2024-10-14	Warnings	Exact identifier application number: M016
Target Up and Up Petroleum Jelly	WHITE PETROLATUM	TARGET CORPORATION	baeaf660-ac4f-1ebc-e053-2995a90ac0c1	2024-10-14	Warnings	Exact identifier application number: M016
Target Up and Up Healing Petrolatum Skin Protectant	PETROLATUM	TARGET CORPORATION	f9b62cd9-94ec-26b4-e053-6394a90a8267	2024-10-14	Warnings	Exact identifier application number: M016
COCOA BUTTER PETROLEUM jelly	PETROLATUM	Universal Distribution Center LLC	c1b10d34-2905-4ad6-8f90-7f9800de2b46	2024-10-14	Warnings	Exact identifier application number: M016
Gentle STEPS vitamins A and D Diaper Rash and Skin Protectant	LANOLIN, PETROLATUM	Old East Main CO.	1d20d040-ed6c-4ce9-81a9-3bbf2fa4587d	2024-10-11	Warnings	Exact identifier application number: M016
McKesson Skin Protectant	ZINC OXIDE	McKesson Medical-Surgical Inc.	50b2709d-aab1-42d8-8ebd-bfd2e1ac6a7b	2024-10-11	Warnings	Exact identifier application number: M016
Medline	WHITE PETROLATUM	Medline Industries, LP	e1089e9a-ecaa-5c65-e053-2995a90a8699	2024-10-10	Warnings	Exact identifier application number: M016
Attitude Diaper Cream Zinc Unscented	ZINC OXIDE	9055-7588 Quebec Inc. (Attitude)	00283894-ddc6-0faa-e063-6394a90ae47c	2024-10-02	Warnings	Exact identifier application number: M016
DermacinRx Zinc Oxide Skin Healing	ZINC OXIDE	PureTek Corporation	541b8da8-f0c1-4f57-94a7-193084d9a611	2024-10-02	Warnings	Exact identifier application number: M016
Dimopair	DIMETHICONE	PureTek Corporation	dc16af56-b97d-c17f-e053-2995a90a55a0	2024-10-01	Warnings	Exact identifier application number: M016
Skin Repair Complex	DIMETHICONE	PureTek Corporation	1c3059c5-5f7e-264e-e054-00144ff8d46c	2024-10-01	Warnings	Exact identifier application number: M016
Barrier Build Skin Protectant Cream	COLLOIDAL OATMEAL	ILIA, Inc.	231d41b8-2a56-6eb8-e063-6394a90ac64f	2024-09-27	Warnings	Exact identifier application number: M016
insect bite relief 01	MENTHOL	Cosmuses Cosmetics (Ningbo) Co., Ltd.	229ee3a7-4129-7b59-e063-6394a90a6f40	2024-09-23	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53329-995-04	53329099504	118 mL in 1 TUBE (53329-995-04)	118 ml	2019-11-01	0000-00-00	No	No	Current
53329-995-13	53329099513	59 mL in 1 TUBE (53329-995-13)	59 ml	2019-11-01	0000-00-00	No	No	Current
53329-995-23	53329099523	946 mL in 1 TUBE (53329-995-23)	946 ml	2019-11-01	0000-00-00	No	No	Current
53329-995-84	53329099584	1000 mL in 1 BAG (53329-995-84)	1000 ml	2019-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
995 Remedy® with Phytoplex® Intensive Skin Therapy Skin Repair Cream	Medline Industries, LP	2024-05-13	HUMAN OTC DRUG LABEL	7