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 36 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
JAFRA Fruteria Coco Fresco Lip Balm	DIMETHICONE	Distribuidora Comercial Jafra, S.A. de C.V.	9895a320-8a74-4b27-9bf1-4b492f89888c	2025-10-21	Warnings	Exact identifier application number: M016
JAFRA Fruteria So Citrico	DIMETHICONE	Distribuidora Comercial Jafra, S.A. de C.V.	a68d6cda-2268-440a-9ca6-677c4e3ea0e7	2025-10-21	Warnings	Exact identifier application number: M016
JAFRA Fruteria Very Verde Lip Balm	DIMETHICONE	Distribuidora Comercial Jafra, S.A. de C.V.	4f0de70b-7ebe-4381-9b46-d5b334f426e0	2025-10-21	Warnings	Exact identifier application number: M016
Gelmicin Hydrocortisone with Aloe	HYDROCORTISONE	United Exchange Corp.	bb64eca4-799d-4711-e053-2995a90af403	2025-10-21	Warnings	Exact identifier application number: M016
Quadrydern	HYDROCORTISONE	Productos Zapotol Corp	a087ad4d-9a65-19c3-e053-2995a90ab341	2025-10-21	Warnings	Exact identifier application number: M016
VENROCK	ROSEMARY OIL	Guangzhou Oupeng Cosmetics Co., Ltd	4156b669-1817-6280-e063-6394a90aaf3a	2025-10-17	Warnings	Exact identifier application number: M016
Gerigentle-Vitamins A and D	PETROLATUM	Geri-Gentle Corporation	c36c74f7-975b-4e4c-99e3-e6921d782c71	2025-10-17	Warnings	Exact identifier application number: M016
Seacall Dexamethasone Ointment.	DEXAMETHASONE OINTMENT	Guangdong Quadrant Ecological Technology Co., Ltd.	201adf67-773c-34a2-e063-6394a90ac525	2025-10-15	Warnings	Exact identifier application number: M016
Medline	ZINC OXIDE	Medline Industries, LP	dae45414-7401-9536-e053-2a95a90a0a86	2025-10-15	Warnings	Exact identifier application number: M016
Curology Barrier Balm	SKIN BARRIER BALM	Curology	04b2ba38-0f81-be51-e063-6294a90af821	2025-10-15	Warnings	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Medline Industries, LP	34f3581f-39ba-4f28-9237-52f3820ab4c0	2025-10-09	Warnings	Exact identifier application number: M016
Facial Fortress	PYRITHIONE ZINC	Pediatric Solutions, LLC	cdd3c52e-4c32-46c1-bdb3-957b164190bb	2025-10-08	Warnings	Exact identifier application number: M016
Happy Cappy	PYRITHIONE ZINC	Pediatric Solutions, LLC	3d3828d8-ee15-4aff-99d1-a121f0102a00	2025-10-08	Warnings	Exact identifier application number: M016
Purforma Advanced Hand Sanitizer 70% Alcohol	HAND SANITIZER 70% ALCOHOL	Spartan Chemical Company, Inc.	06bd825d-914f-5ca7-e063-6394a90aec49	2025-10-06	Warnings	Exact identifier application number: M016
Scar Reducer Intensive Herbal and Nutrient	ALLANTOIN	Quantum, Inc	5197f1fa-aae5-406c-97d9-635b8c1a88a8	2025-10-06	Warnings	Exact identifier application number: M016
PURE SOL SPF 30 LIP BALM CACOA BUTTER	ZINC OXIDE	Brand 2022b LLC	40537561-d334-5859-e063-6394a90a92a7	2025-10-04	Warnings	Exact identifier application number: M016
PURE SOL SPF15 Lip Gloss original	ZINC OXIDE	Brand 2022b LLC	4056e49a-2976-38f9-e063-6394a90a786d	2025-10-04	Warnings	Exact identifier application number: M016
PURE SOL SPF15 Lip Gloss Nudie rose	ZINC OXIDE	Brand 2022b LLC	4057b0e2-1c31-abae-e063-6294a90a053d	2025-10-04	Warnings	Exact identifier application number: M016
PURE SOL SPF15 Lip Gloss Pink coral	ZINC OXIDE	Brand 2022b LLC	405865dd-7d0e-048d-e063-6394a90ab105	2025-10-04	Warnings	Exact identifier application number: M016
HealthWise Medicated Diabetic Foot Cream	DIMETHICONE, PETROLATUM	Veridian Healthcare	164f4cd8-975a-40d5-e063-6394a90ae7d5	2025-10-02	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