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 62 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetaphil Healing	PETROLATUM	Galderma Laboratories, L.P.	e996db17-bd4d-4b06-bb9a-983dbdec8022	2024-03-13	Warnings	Exact identifier application number: M016
Diaper Rash Cream 2oz	ZINC OXIDE	Rejoice International Corp.	130a06a7-3360-afed-e063-6294a90ac19f	2024-03-06	Warnings	Exact identifier application number: M016
mama bear DIAPER RASH Skin Protectant	LANOLIN AND PETROLATUM	AMAZON.COM SERVICES LLC	cda9ca47-b668-4a65-908d-80b9a6515bd7	2024-03-06	Warnings	Exact identifier application number: M016
Dermachange Scar	ALLANTOIN	Private Label Beauty and Wellness	12eed473-10d6-49c8-e063-6394a90afb63	2024-03-05	Warnings	Exact identifier application number: M016
XtraCare Creamy Petroleum Jelly Cocoa Butter Enriched	PETROLEUM	Rejoice International	580d76ee-ea89-426e-bd25-7a58481e9795	2024-02-28	Warnings	Exact identifier application number: M016
XtraCare Creamy Petroleum Jelly Vitamin E enriched	PETROLATUM	Rejoice International	2c382a50-93d2-4d28-b7a4-1702b20b7139	2024-02-28	Warnings	Exact identifier application number: M016
XtraCare Foaming Facial Cleanser	TRICLOSAN	Rejoice International	313fcd4a-8641-417e-bf0b-02359ad815fe	2024-02-28	Warnings	Exact identifier application number: M016
XtraCare Skin Relief Oatmeal Daily Moisturizing	DIMETHICONE	Rejoice International	5ae6d5d4-caff-4360-a0e7-7c8d7a9b5907	2024-02-28	Warnings	Exact identifier application number: M016
XtraCare with cooling action Oatmeal Skin Relief Calmin	DIMETHICONE	Rejoice International	29abd476-c32d-49f0-b283-30f4ba570ab4	2024-02-28	Warnings	Exact identifier application number: M016
MAX BARRIER Skin Protectant	ZINC OXIDE	GL HEALTH, INC.	5eec834d-d8f3-49e3-b230-f8cf88b795e6	2024-02-26	Warnings	Exact identifier application number: M016
Rugby Petrolatum Hydrating Skin Protectant	PETROLATUM	Rugby Laboratories	ad63e345-1fe8-4f9a-a32e-8dfcde31bedc	2024-02-12	Warnings	Exact identifier application number: M016
A and D	PETROLATUM	Safetec of America, Inc.	b9afda3a-9e1d-46c1-b7aa-c3143caf709e	2024-02-09	Warnings	Exact identifier application number: M016
Blistex Medicated Mint Balm	DIMETHICONE, OCTINOXATE, AND OCTISALATE	Blistex Inc	86fc9f3c-e35f-4988-bf19-64d9c6c85ee9	2024-02-09	Warnings	Exact identifier application number: M016
Blistex Medicated Berry Balm	DIMETHICONE, OCTINOXATE, AND OCTISALATE	Blistex Inc	827365b3-b3a5-4472-9add-f822362c4731	2024-02-09	Warnings	Exact identifier application number: M016
Blistex Medicated Lip Balm	DIMETHICONE, OCTINOXATE, AND OCTISALATE	Blistex Inc	8b4160ed-8889-4e3a-947f-a56c3324dbbe	2024-02-09	Warnings	Exact identifier application number: M016
Medline	WHITE PETROLATUM, ZINC OXIDE	Medline Industries, LP	101b9933-c2b8-0fdd-e063-6294a90a306a	2024-01-29	Warnings	Exact identifier application number: M016
XtraCare Skin Relief Oatmeal Daily Moisturizing	DIMETHICONE	Rejoice International	8d9e0893-c9be-4f5a-afc2-b5b997c8d1cc	2024-01-29	Warnings	Exact identifier application number: M016
Cetaphil Baby Healing	PETROLATUM	Galderma Laboratories, L.P.	5140754e-5db0-470f-adfd-de02b184880b	2024-01-29	Warnings	Exact identifier application number: M016
CHAPSTICK CLASSIC MEDICATED	CAMPHOR, MENTHOL, PETROLATUM	Haleon US Holdings LLC	b4259621-ff41-46cc-a658-b57bff3c1525	2024-01-23	Warnings	Exact identifier application number: M016
Zinc Oxide 20%	ZINC OXIDE	Trifecta Pharmaceuticals USA	fcef17f1-84e7-a288-e053-6294a90a064b	2024-01-19	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