Aloetouch Protect

Product NDC: 53329-059
Requested package NDC: 53329-059-91
11-digit product format: 533290059
Labeler code: 53329
Product ID: 53329-059_5a6fdb31-f69a-0a49-e063-6394a90a410a
Type: HUMAN OTC DRUG
Nonproprietary name: Dimethicone
Dosage form: CLOTH
Route: TOPICAL
Labeler: Medline Industries, LP
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-08-01
Substance: DIMETHICONE
Active strength: 3.2 g/100mL
Pharmacologic classes: Skin Barrier Activity [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53329-059	53329-059-91	D	Discontinued by firm		2026-10-05

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: Aloetouch Protect
Brand name suffix: Fragrance Free
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIMETHICONE	3.2 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
92RU3N3Y1O	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1039149	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
81f0071b-2bf3-455b-9e5d-8f3ca20adcdf	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53329-059-02	Aloetouch ProtectFragrance Free	17 mL in 1 APPLICATOR	CLOTH	17	10
53329-059-02	Aloetouch ProtectFragrance Free	3 in 1 PACKAGE	CLOTH	3	10
53329-059-58	Aloetouch ProtectFragrance Free	24 in 1 PACKAGE	CLOTH	24	10
53329-059-58	Aloetouch ProtectFragrance Free	9.2 mL in 1 APPLICATOR	CLOTH	9.2	10
53329-059-62	Aloetouch ProtectFragrance Free	11 mL in 1 APPLICATOR	CLOTH	11	10
53329-059-62	Aloetouch ProtectFragrance Free	60 in 1 PACKAGE	CLOTH	60	10
53329-059-76	Aloetouch ProtectFragrance Free	8 in 1 PACKAGE	CLOTH	8	10
53329-059-76	Aloetouch ProtectFragrance Free	19 mL in 1 APPLICATOR	CLOTH	19	10
53329-059-91	Aloetouch ProtectFragrance Free	9.2 mL in 1 APPLICATOR	CLOTH	9.2	10
53329-059-91	Aloetouch ProtectFragrance Free	48 in 1 PACKAGE	CLOTH	48	10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	ALOETOUCH PROTECT SKIN PROTECTANT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	ALOETOUCH PROTECT SKIN PROTECTANT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	ALOETOUCH PROTECT SKIN PROTECTANT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	ALOETOUCH PROTECT SKIN PROTECTANT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ALOETOUCH PROTECT SKIN PROTECTANT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE	INACTIVE INGREDIENT	H2KVQ74JM4	ALOETOUCH PROTECT SKIN PROTECTANT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	ALOETOUCH PROTECT SKIN PROTECTANT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE	INACTIVE INGREDIENT	5Q87K461JO	ALOETOUCH PROTECT SKIN PROTECTANT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	ALOETOUCH PROTECT SKIN PROTECTANT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ALOETOUCH PROTECT SKIN PROTECTANT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	ALOETOUCH PROTECT SKIN PROTECTANT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-059	ALOETOUCH PROTECT FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, LP]	9	Current NDC, Legacy NDC, 10 package rows	20241204_81f0071b-2bf3-455b-9e5d-8f3ca20adcdf.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 67 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EltaMD Laser Balm	PETROLATUM SKIN PROTECTANT	CP Skin Health Group, Inc	1c67ce72-89d9-4c4f-a9b0-28b7e67d30eb	2023-11-09	Warnings	Exact identifier application number: M016
DiaperDerm Diaper Rash	ZINC OXIDE	Diaperderm Inc	4e1fce3e-c2b7-42da-9953-1dbb13e2467c	2023-11-06	Warnings	Exact identifier application number: M016
Doctors Diaper Rash Cream	ZINC OXIDE	DOCTOR'S DIAPER RASH CREAM, INC	0988ccb1-7881-4d97-bcbf-d0cf4316e4be	2023-11-06	Warnings	Exact identifier application number: M016
DERMOIA Manuka Honey Eczema Cream	OATMEAL	TREASUREWISE LLC	a48e52a3-b681-4489-a1fd-6b09d8bc9c55	2023-11-06	Warnings	Exact identifier application number: M016
GL HEALTH Barrier Skin Protectant	ZINC OXIDE	GL HEALTH, INC.	76cfa330-fea9-48d4-b187-469154765d39	2023-11-06	Warnings	Exact identifier application number: M016
Skin-lube	PETROLATUM, DIMETHICONE	The Hygenic Company, LLC.	d1005dec-04f6-3f88-e053-2a95a90ad9cb	2023-11-05	Warnings	Exact identifier application number: M016
Dr. Sheffield Anti Itch Cream	ANTI ITCH CREAM	Sheffield Pharmaceuticals LLC	77f0593e-f694-4c02-9fd9-ad56ff2a920c	2023-10-30	Warnings	Exact identifier application number: M016
calahist	CALAMINE AND PRAMOXINE HYDROCHLORIDE	WALGREEN COMPANY	fed45e06-cc53-fbc5-e053-6294a90a1b19	2023-10-27	Warnings	Exact identifier application number: M016
calahist clear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	WALGREEN COMPANY	fed469c2-fe13-6726-e053-6394a90a5f51	2023-10-27	Warnings	Exact identifier application number: M016
Dr. Sayman Salve	SALVE	Sheffield Pharmaceuticals LLC	18bdcd0c-9c81-47e1-ae24-2239ff8fd066	2023-10-24	Warnings	Exact identifier application number: M016
Theriac Advanced Healing	LANOLIN	Sheffield Pharmaceuticals LLC	c780cd27-dc9e-45f3-97f0-e59b1b6b955a	2023-10-24	Warnings	Exact identifier application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash	ZINC OXIDE	Babo Botanicals, Inc.	d66e369e-9b19-b084-e053-2995a90aa259	2023-10-23	Warnings	Exact identifier application number: M016
Babo Botanicals Sensitive Baby Healing	COLLOIDAL OATMEAL	Babo Botanicals, Inc.	08659a5c-2d10-2f98-e063-6394a90a7760	2023-10-23	Warnings	Exact identifier application number: M016
White Rose Petroleum Jelly	PETROLATUM	J. Strickland & Co.	1aeb090d-c103-4c2e-accc-d9d248315db9	2023-10-21	Warnings	Exact identifier application number: M016
Tricalm Hydrogel	ALUMINUM ACETATE	MODULAR THERMAL TECHNOLOGIES LLC DBA LIFE WEAR TECHNOLOGIES	082c6441-be47-4466-e063-6394a90ad500	2023-10-20	Warnings	Exact identifier application number: M016
Empower	WHITE PETROLATUM, ZINC OXIDE	Bemis Manufacturing Company Inc	08006b60-966b-155b-e063-6294a90a206a	2023-10-18	Warnings	Exact identifier application number: M016
ANUBISMED	HA HYALURONIC	ANUBIS COSMETICS SL	eac771e2-4c1b-3808-e053-2995a90ac5fc	2023-09-05	Warnings	Exact identifier application number: M016
AnubisMed	SODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREA	ANUBIS COSMETICS SL	ebf4b3ab-34e1-185a-e053-2a95a90ace3a	2023-09-05	Warnings	Exact identifier application number: M016
Anubis Barcelona	GLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICE	ANUBIS COSMETICS SL	eb651769-4d98-2b3b-e053-2a95a90a36b0	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona	DMAE	ANUBIS COSMETICS SL	f22b212d-d21d-5984-e053-2995a90a683e	2023-09-01	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1039149	dimethicone 3.2 % Medicated Pad	PSN	81f0071b-2bf3-455b-9e5d-8f3ca20adcdf	10
1039149	dimethicone 32 MG/ML Medicated Pad	SCD	81f0071b-2bf3-455b-9e5d-8f3ca20adcdf	10
1039149	dimethicone 3.2 % Medicated Pad	SY	81f0071b-2bf3-455b-9e5d-8f3ca20adcdf	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53329-059-91	53329005991	48 APPLICATOR in 1 PACKAGE (53329-059-91) > 9.2 mL in 1 APPLICATOR	48 applicator	2014-07-01	2022-11-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
059 Remedy Essentials Skin Protectant Wipes	Medline Industries, LP	2026-09-01	HUMAN OTC DRUG LABEL	11