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	2026-10-12
excluded package	package	53329-995	53329-995-04	D	Discontinued by firm	2026-10-12
excluded package	package	53329-995	53329-995-13	D	Discontinued by firm	2026-10-12
excluded package	package	53329-995	53329-995-23	D	Discontinued by firm	2026-10-12
excluded package	package	53329-995	53329-995-84	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 · 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 16 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
First Aid Beauty FAB Ultra Repair Body Skin Protectant	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	1a9d86fc-ef32-baed-e063-6394a90a7d74	2026-03-12	Warnings	Exact identifier application number: M016
Meijer Scar Gel	ALLANTOIN 0.5%	Meijer	4c108c34-72f3-1382-e063-6394a90a7f2c	2026-03-11	Warnings	Exact identifier application number: M016
E2 hand wash	E2 SANITIZING HAND SOAP	Horizon Tool Inc.	a40afa46-a07d-f864-e053-2a95a90aef8a	2026-03-11	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Sugar Cookie	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	4576cd28-9530-4db4-e063-6394a90a9fd3	2026-03-10	Warnings	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Lidl US, LLC	e399b33f-5f7c-47eb-8e9b-1721ae4680b5	2026-03-10	Warnings, Adverse reactions	Exact identifier application number: M016
Vitamin A D	WHITE PETROLATUM	Sion Biotext Medical Ltd.	503c4ab9-1f60-48e2-af47-7ef996466a5b	2026-03-09	Warnings	Exact identifier application number: M016
Trstay	RETINOL SERUM	Shenzhen yuehaotong Technology Co.,Ltd	4c6e20dd-0a71-a96b-e063-6294a90ab833	2026-03-07	Warnings	Exact identifier application number: M016
2-Pack Facial Serum	2-PACK FACIAL SERUM	Guangzhou Ariel Biotech Co., Ltd.	27c7f645-cfb3-6db1-e063-6394a90a42ff	2026-03-06	Warnings	Exact identifier application number: M016
2-Pack Facial Serum	2-PACK FACIAL SERUM	Guangzhou Ariel Biotech Co., Ltd.	27c89fc6-016b-d359-e063-6394a90a5602	2026-03-06	Warnings	Exact identifier application number: M016
Boudreauxs	ZINC OXIDE	C.B. Fleet Company, Inc.	f8f626c8-13ae-4b3b-ae3f-e0dc800fcb4a	2026-03-06	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant	DIMETHICONE	The Procter & Gamble Manufacturing Company	276c68d4-e273-4e48-e063-6294a90ab16f	2026-03-04	Warnings	Exact identifier application number: M016
Nicotine Patches	NICOTINE PATCHES	Zhejiang FTA Shengzuozhi Biotechnology Co., LTD	4c1d00b3-313b-933f-e063-6294a90ac46f	2026-03-03	Warnings	Exact identifier application number: M016
Zinc Oxide	ZINC OXIDE	Amazon.com Services LLC	495fffd7-7b64-954a-e063-6394a90a81fd	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	CALAMINE, PRAMOXINE HCL	Amazon.com Services LLC	aceb0b10-8c90-4a06-8c47-cd1a2b4676a3	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL	Amazon.com Services LLC	134e07a1-5236-4088-baf9-1ff33126f793	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Old East Main Co.	7f56ab98-dbd8-412a-8c31-bb6302b7f329	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	Old East Main Co.	c38c77fd-abbf-4c87-a9c0-a0e21ed3f97d	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Pure petroleum	WHITE PETROLATUM	Old East Main Co.	ae8583c0-1b52-461d-8506-ec7524f1b4c4	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Healing for Babies	PETROLATUM	Old East Main Co.	aa1acc24-56af-4708-bf76-23d4de3d089e	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Old East Main Co.	de8d8071-ecb2-4719-8c7b-7944f27810d6	2026-03-02	Warnings, Adverse reactions	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