Medline

Product NDC: 53329-159
11-digit product format: 533290159
Labeler code: 53329
Product ID: 53329-159_5c3e33fc-648e-a2a3-e063-6294a90a4845
Type: HUMAN OTC DRUG
Nonproprietary name: dimethicone
Dosage form: CREAM
Route: TOPICAL
Labeler: Medline Industries, LP
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-04-01
Substance: DIMETHICONE
Active strength: 125 mg/mL
Pharmacologic classes: Skin Barrier Activity [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Medline
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIMETHICONE	125 mg/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
16a2c1cd-ae95-d910-f03d-7e06b11dd243	Product name	5	20260202
653485de-0601-41e4-82db-7a60bb223e27	Product name	1	20251024
ef9a935e-31b7-402c-a66c-716cdfe4f126	Product name	9	20241218
23fb3cda-2b50-f3d3-ebde-f542350bd77b	Product name	4	20240828
081b54f0-4545-48b6-b854-03e1401f09ea	Product name	1	20230112
115c5bd2-98e1-4a98-8292-90803ca7e851	Product name	1	20220127
aead65a2-216e-4ff8-a178-44aab77c24ed	Product name	1	20180531
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53329-159-04	Medline	118 mL in 1 TUBE	CREAM	118	3
53329-159-13	Medline	59 mL in 1 TUBE	CREAM	59	3
53329-159-77	Medline	4 mL in 1 PACKET	CREAM	4	3
53329-159-96	Medline	4 mL in 1 PACKET	CREAM	4	3
53329-159-96	Medline	144 in 1 BOX	CREAM	144	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-159	MEDLINE (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, LP]	3	Current NDC, 5 package rows	20240514_ddab5235-1188-3866-e053-2a95a90a7a31.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 7 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dr Sosnowskis Magic Healing Multi action	CAMPHOR AND COLLOIDAL OATMEAL	Herstat (USA) Inc.	38cd8f11-7264-a004-e063-6294a90a3a1b	2026-07-03	Warnings	Exact identifier application number: M016
Petroleum Skin Protectant	WHITE PETROLATUM	Publix Super Markets, Inc.	c94b5574-3fd7-48a8-94ef-db5d7184fa10	2026-07-02	Warnings, Adverse reactions	Exact identifier application number: M016
Drs. Pharmacy Baby Healing	ZINC OXIDE	OL PHARMA TECH, LLC Drs PHARMACY	55a6981c-1b32-f448-e063-6294a90ac6d8	2026-07-02	Warnings	Exact identifier application number: M016
AVANCE ALOE INCONTINENCE CARE	DIMETICONE	SMART CHOICE MEDICAL INC.	558d239e-b0cf-c145-e063-6294a90a8a8b	2026-07-01	Warnings	Exact identifier application number: M016
DIMETHICONE SKIN PROTECTANT	DIMETHICONE	VIVE HEALTH LLC	5591a321-4831-1844-e063-6394a90a12d1	2026-07-01	Warnings	Exact identifier application number: M016
Drs. Pharmacy healing	PETROLATUM	OL PHARMA TECH, LLC Drs PHARMACY	55947cd9-ca25-0844-e063-6294a90a381f	2026-07-01	Warnings	Exact identifier application number: M016
AVANCE ALOE INCONTINENCE CARE	DIMETICONE	SMART CHOICE MEDICAL INC.	55833e0f-d184-16a2-e063-6394a90acfd3	2026-06-30	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Summer Grapefruit	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	55664a0f-7d46-f002-e063-6394a90a2dc7	2026-06-29	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Frosted Grapefruit	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	5566bce3-fc49-5ef4-e063-6294a90abc7a	2026-06-29	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Cream Skin Protectant Velvet Plum	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	5568ada5-3ae6-3366-e063-6294a90a7119	2026-06-29	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Toasted Coconut	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	55698d88-aae7-c46c-e063-6394a90ad0ac	2026-06-29	Warnings	Exact identifier application number: M016
Earth Baby Diaper Rash Cream	ZINC OXIDE	Earth Baby, Inc	42c5cf9a-0a35-5681-e054-00144ff8d46c	2026-06-28	Warnings	Exact identifier application number: M016
ORLASKIN HYDROGEL EYE MASK	ALLANTOIN	Guangzhou Yapheon Health Industry Co., Ltd.	552d072b-396f-c88a-e063-6294a90aabcd	2026-06-26	Warnings	Exact identifier application number: M016
Medline	WHITE PETROLATUM	Medline Industries, LP	3c442890-733d-8175-e063-6294a90a8b1c	2026-06-24	Warnings	Exact identifier application number: M016
MOROVAN	ESTRIOL	HONG KONG UNORDERED TRADING CO., LIMITED	54fa4308-44a4-e9dd-e063-6394a90a0cd7	2026-06-24	Warnings	Exact identifier application number: M016
EELHOE Sleep Aid Patch	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	550b0494-ca6d-c897-e063-6394a90a8751	2026-06-24	Warnings	Exact identifier application number: M016
Hair Regrowth Liquid	GLYCERIN	Shantou Woodsleep Biotechnology Co., Ltd.	54e662e7-9c63-ad6b-e063-6294a90a1b8d	2026-06-23	Warnings	Exact identifier application number: M016
RoyceDerm Eczema Relief Body Wash	COLLOIDAL OATMEAL 2%	RoyceDerm LLC	54e74eb4-1b42-a748-e063-6394a90aeb16	2026-06-23	Warnings	Exact identifier application number: M016
Comfort Shield Barrier	DIMETHICONE	Sage Products LLC	cc08f571-84ae-4c2f-b09d-a83a8efc39f5	2026-06-23	Warnings	Exact identifier application number: M016
CLEAR ANTI ITCH	PRAMOXINE HCL, ZINC ACETATE LOTION	H E B	54f04056-d805-8c62-e063-6394a90ab740	2026-06-23	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
2613881	dimethicone 12.5 % Topical Cream	PSN	ddab5235-1188-3866-e053-2a95a90a7a31	3
2613881	dimethicone 125 MG/ML Topical Cream	SCD	ddab5235-1188-3866-e053-2a95a90a7a31	3
2613881	dimethicone 12.5 % Topical Cream	SY	ddab5235-1188-3866-e053-2a95a90a7a31	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
53329-159-04	53329015904	118 mL in 1 TUBE (53329-159-04)	118 ml	2023-04-01	No	No	Current
53329-159-13	53329015913	59 mL in 1 TUBE (53329-159-13)	59 ml	2023-05-01	No	No	Current
53329-159-77	53329015977	4 mL in 1 PACKET (53329-159-77)	4 ml	2024-05-01	No	No	Current
53329-159-96	53329015996	144 PACKET in 1 BOX (53329-159-96) / 4 mL in 1 PACKET	144 packet	2024-05-01	No	No	Current