Medline Remedy Phytoplex Skin Repair

Product NDC: 53329-152
11-digit product format: 533290152
Labeler code: 53329
Product ID: 53329-152_e9b1a475-b6ae-035e-e053-2a95a90aa421
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: 2018-02-12
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53329-152		D	Discontinued by firm	2026-10-12
excluded package	package	53329-152	53329-152-04	D	Discontinued by firm	2026-10-12
excluded package	package	53329-152	53329-152-14	D	Discontinued by firm	2026-10-12
excluded package	package	53329-152	53329-152-17	D	Discontinued by firm	2026-10-12
excluded package	package	53329-152	53329-152-44	D	Discontinued by firm	2026-10-12
excluded package	package	53329-152	53329-152-64	D	Discontinued by firm	2026-10-12
excluded package	package	53329-152	53329-152-84	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 · 14 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	53329-152-17	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-152-64	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-152-44	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-152-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-152-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-152-84	`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	53329-152-17	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-152-64	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-152-44	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-152-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-152-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-152-84	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
16a2c1cd-ae95-d910-f03d-7e06b11dd243	Product name	5	20260202
d4d7da1a-7fd4-628e-cdae-89e749b1c534	Product name	7	20260127
75f7e47b-8736-a182-fc44-22aca8d79689	Product name	2	20251211
653485de-0601-41e4-82db-7a60bb223e27	Product name	1	20251024
62986c8d-91f1-b1ba-b5a3-8b54b75bb8c2	Product name	6	20250516
ef9a935e-31b7-402c-a66c-716cdfe4f126	Product name	9	20241218
23fb3cda-2b50-f3d3-ebde-f542350bd77b	Product name	4	20240828
e42f429b-c4e5-0402-e1c5-730154df4060	Product name	4	20240205
081b54f0-4545-48b6-b854-03e1401f09ea	Product name	1	20230112
38d4de13-64b3-4057-b91c-4b5126962341	Product name	1	20220516
115c5bd2-98e1-4a98-8292-90803ca7e851	Product name	1	20220127
089e0644-1ea8-8654-4113-39f960dd57d5	Product name	3	20210115
1629e00f-54fb-4a43-8306-b58442b23902	Product name	9	20200430
5331c9c8-f64b-11e6-ccf1-071c477fcb0b	Product name	7	20190612
aead65a2-216e-4ff8-a178-44aab77c24ed	Product name	1	20180531
9f64e0dc-109c-9660-8e0e-91ec987b3817	Product name	6	20171204
dfa879a3-32de-49f0-a7ba-9b9c3e13002f	Product name	1	20171204
8de20f81-8411-4cf1-a8b2-03404ee56d01	Product name	3	20171109
a5f1a68c-0352-4f34-46a3-9b4eed239ed8	Product name	2	20160819
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
355b2224-0895-7135-83f5-d099a6a82a0a	Product name	1	20140508
55be6b50-8cc0-f0f1-74a1-3416a91193aa	Product name	1	20140508
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cf	Product name	1	20140508
89b93c13-4be8-69f3-b33b-63e64feffb9b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53329-152-44	Trivix	118 mL in 1 TUBE	CREAM	118 mL	5 g in 100mL	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53329-152-04	GM - Gram	53329-152	39008f22-6a04-4e7c-95fb-7bc29f80f0f3	1	2018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-152	MEDLINE REMEDY PHYTOPLEX SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, LP]	10	Legacy NDC	20240514_629d0aad-bde9-e07a-e053-2a91aa0a05c8.zip
53329-152	TRIVIX (TRIAMCINOLONE ACETONIDE CREAM .1%, DIMETHICONE 5% CREAM) KIT [PRIMARY PHARMACEUTICALS, INC.]	1	Legacy NDC	20190925_8f64204b-1bcd-2ee0-e053-2995a90af8c7.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 20 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diaper Rash	ZINC OXIDE	Target Corporation	8059f489-f144-4de5-9454-ac6c1af35dd2	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M016
Coconut Milk and Shea Petroleum Jelly	WHITE PETROLATUM	Target Corporation	c78d9864-92e0-4ad8-8a9b-9752ac6784e8	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Strategic Sourcing Services LLC	043375b2-e636-4822-9e05-df2327d29986	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Strategic Sourcing Services LLC	3ade1f7f-a870-4f77-96b9-f63bf4cdf5ae	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M016
Pure petroleum	WHITE PETROLATUM	Valu Merchandisers Company	4113bb6e-070a-4116-a8d6-12c6b4475beb	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Valu Merchandisers Company	e5465ddd-e38c-44a4-bb9b-3edbc636576d	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Valu Merchandisers Company	8b8decec-e921-4ff9-bb49-7e38e34724f6	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M016
Daily Moisturizing	DIMETHICONE	Valu Merchandisers Company	0cccadd7-11f3-5d1f-e063-6294a90a55c4	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL	Valu Merchandisers Company	7c6fa37f-79b8-4409-b7a9-3f02332f887a	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	United Natural Foods, Inc. dba UNFI	014d0028-486e-4f1c-a14f-8162e393ebca	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	United Natural Foods, Inc. dba UNFI	29a3a719-5e8b-407d-b9d9-bdba26758292	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Topco Associates LLC	8acb1b47-70ed-4aa2-a7c0-e807042affc7	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	Topco Associates LLC	2b32e720-ac71-4d60-bc06-e28a00f8a450	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Pure petroleum	WHITE PETROLATUM	Topco Associates LLC	3babe2cf-9e6c-4f22-940f-c1fdf489f1c7	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Clear Anti Itch	PRAMOXINE HCL, ZINC ACETATE	Topco Associates LLC	8d3d1ff5-4868-495d-807c-e45aa2176f63	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Healing	PETROLATUM	Topco Associates LLC	b929b159-4af5-4a03-8e7c-676a6ba2bf55	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	CALAMINE, PRAMOXINE HCL	Topco Associates LLC	15d1ae3f-509c-4e6b-8f0c-cf9265680358	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Topco Associates LLC	cd7f1727-0b6e-4993-9820-43783994efa1	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Dimethicone	DIMETHICONE	Topco Associates LLC	f37f17f7-f084-4b74-8361-178d2315a476	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Baby Eczema Therapy	COLLOIDAL OATMEAL	Topco Associates LLC	4f6af42c-f41e-455f-b94b-3793bf0b9a3f	2026-02-13	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
259090	dimethicone 5 % Topical Cream	PSN	8f64204b-1bcd-2ee0-e053-2995a90af8c7	1
1014314	triamcinolone acetonide 0.1 % Topical Cream	PSN	8f64204b-1bcd-2ee0-e053-2995a90af8c7	1
259090	dimethicone 50 MG/ML Topical Cream	SCD	8f64204b-1bcd-2ee0-e053-2995a90af8c7	1
1014314	triamcinolone acetonide 1 MG/ML Topical Cream	SCD	8f64204b-1bcd-2ee0-e053-2995a90af8c7	1
259090	dimethicone 5 % Topical Cream	SY	8f64204b-1bcd-2ee0-e053-2995a90af8c7	1
1014314	triamcinolone acetonide 0.1 % Topical Cream	SY	8f64204b-1bcd-2ee0-e053-2995a90af8c7	1
1014314	triamcinolone acetonide 1 MG per GM Topical Cream	SY	8f64204b-1bcd-2ee0-e053-2995a90af8c7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53329-152-04	53329015204	4.14 mL in 1 PACKET (53329-152-04)	4.14 ml	2018-02-12	0000-00-00	No	No	Current
53329-152-14	53329015214	59 mL in 1 TUBE (53329-152-14)	59 ml	2018-02-12	0000-00-00	No	No	Current
53329-152-17	53329015217	144 PACKET in 1 BOX (53329-152-17) > 4.14 mL in 1 PACKET (53329-152-04)	144 packet	2018-04-03	0000-00-00	No	No	Current
53329-152-44	53329015244	118 mL in 1 TUBE (53329-152-44)	118 ml	2018-02-12	0000-00-00	No	No	Current
53329-152-64	53329015264	946.353 mL in 1 TUBE (53329-152-64)	946.353 ml	2018-04-03	0000-00-00	No	No	Current
53329-152-84	53329015284	1000 mL in 1 BOTTLE (53329-152-84)	1000 ml	2019-02-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
152 Remedy Intensive Skin Therapy Skin Repair Cream, Orange Vanilla Scent	Medline Industries, LP	2024-05-13	HUMAN OTC DRUG LABEL	10
CALSODORE CREAM USP, 0.005%	FORREAL PHARMACEUTICALS LLC	2023-11-16	HUMAN PRESCRIPTION DRUG LABEL	2
MOMETACURE	FORREAL PHARMACEUTICALS LLC	2023-11-08	HUMAN PRESCRIPTION DRUG LABEL	3
TriaDime	ForReal Pharmaceuticals	2023-05-03	HUMAN PRESCRIPTION DRUG LABEL	1
TriaDime-80	ForReal Pharmaceuticals \| Teligent	2021-09-28	HUMAN PRESCRIPTION DRUG LABEL	5
TriHeal-80	ForReal Pharmaceuticals	2021-08-12	HUMAN PRESCRIPTION DRUG LABEL	3
Trivix	Primary Pharmaceuticals, Inc. \| Biomed Laboratories, LLC. \| Perrigo Israel Pharmaceuticals LTD. \| Rainbow Gold	2019-08-05	HUMAN PRESCRIPTION DRUG LABEL	1