FDA.reportPublic FDA data

Aloetouch Protect

Product NDC
53329-059
Requested package NDC
53329-059-02
11-digit product format
533290059
Labeler code
53329
Product ID
53329-059_499e65fe-899a-b4e5-e063-6394a90ad49a
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53329-05953329-059-02DDiscontinued by firm2026-08-03

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
IngredientStrength
DIMETHICONE3.2 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92RU3N3Y1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
81f0071b-2bf3-455b-9e5d-8f3ca20adcdfAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-059-02Aloetouch ProtectFragrance Free17 mL in 1 APPLICATORCLOTH1710
53329-059-02Aloetouch ProtectFragrance Free3 in 1 PACKAGECLOTH310
53329-059-58Aloetouch ProtectFragrance Free24 in 1 PACKAGECLOTH2410
53329-059-58Aloetouch ProtectFragrance Free9.2 mL in 1 APPLICATORCLOTH9.210
53329-059-62Aloetouch ProtectFragrance Free11 mL in 1 APPLICATORCLOTH1110
53329-059-62Aloetouch ProtectFragrance Free60 in 1 PACKAGECLOTH6010
53329-059-76Aloetouch ProtectFragrance Free8 in 1 PACKAGECLOTH810
53329-059-76Aloetouch ProtectFragrance Free19 mL in 1 APPLICATORCLOTH1910
53329-059-91Aloetouch ProtectFragrance Free9.2 mL in 1 APPLICATORCLOTH9.210
53329-059-91Aloetouch ProtectFragrance Free48 in 1 PACKAGECLOTH4810

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OALOETOUCH PROTECT SKIN PROTECTANT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
DIMETHICONEACTIVE MOIETY92RU3N3Y1OALOETOUCH PROTECT SKIN PROTECTANT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XALOETOUCH PROTECT SKIN PROTECTANT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7ALOETOUCH PROTECT SKIN PROTECTANT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPALOETOUCH PROTECT SKIN PROTECTANT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEINACTIVE INGREDIENTH2KVQ74JM4ALOETOUCH PROTECT SKIN PROTECTANT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KALOETOUCH PROTECT SKIN PROTECTANT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEINACTIVE INGREDIENT5Q87K461JOALOETOUCH PROTECT SKIN PROTECTANT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHALOETOUCH PROTECT SKIN PROTECTANT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALOETOUCH PROTECT SKIN PROTECTANT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RALOETOUCH PROTECT SKIN PROTECTANT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-059ALOETOUCH PROTECT FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, LP]9Current NDC, Legacy NDC, 10 package rows20241204_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 12 of 69 · 1,363 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triple Diaper RashZINC OXIDEAdvantice Health, LLCd457c58d-8239-41c4-999e-d0ba237e39452026-03-19WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Cranberry PomegranateCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companyf4464fb2-ba25-16f2-e053-2a95a90a04062026-03-19WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Vanilla CookieCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companyfea4e5c7-780c-c7f4-e053-6294a90abb392026-03-19WarningsExact identifier
application number: M016
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD4d46110b-5aa7-5261-e063-6394a90a423a2026-03-18WarningsExact identifier
application number: M016
Advanced Bed Sore Wound HealingALLANTOINYantai Aien Biotechnology Co., Ltd.4d589c18-e597-355a-e063-6394a90a42432026-03-18WarningsExact identifier
application number: M016
MediChoice BarrierDIMETHICONEO&M HALYARD, INC.115c2a2f-d68a-316a-e063-6394a90a27162026-03-17WarningsExact identifier
application number: M016
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD4d4427b0-25c3-ddf6-e063-6394a90a61532026-03-17WarningsExact identifier
application number: M016
Colloidal OatmealCOLLOIDAL OATMEALWalmart Inc.4a93f77d-41dc-3bab-e063-6394a90a804b2026-03-16Warnings, Adverse reactionsExact identifier
application number: M016
VaselineHEALING JELLYConopco Inc. d/b/a Unileverbd4418b7-c6aa-5e71-e053-2995a90a4cc42026-03-16WarningsExact identifier
application number: M016
Vaseline Intensive Care Deep MoisturePETROLEUMConopco Inc. d/b/a Unilever65cec560-25c7-4076-a33d-a3dd534ff85b2026-03-16WarningsExact identifier
application number: M016
Daily MoisturizingDAILY MOISTRUIZINGWalgreen Co.27452cc7-1ec6-4571-bcd0-0a7103735ee52026-03-13Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXIND HCLNice-Pak Products, LLC9089e23e-ca4a-454f-8dcc-ff5a29a5a3352026-03-13Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELNice-Pak Products, LLCf1e68ec8-f269-40c8-863f-69290812feed2026-03-13Warnings, Adverse reactionsExact identifier
application number: M016
Eczema Soothing Moisturizing CreamCOLLOIDAL OATMEALNice-Pak Products, LLC23548524-2e2e-4d1a-9ebb-6f86d6279e932026-03-13Warnings, Adverse reactionsExact identifier
application number: M016
Tender Moments Delicate Baby Diaper Rash BalmDIMETHICONE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.f09ba452-e1a6-4f45-901f-bb63d4f8e8842026-03-13WarningsExact identifier
application number: M016
Diaper RashZINC OXIDENice-Pak Products, LLC66771beb-9c14-48a8-a850-000e4cd73a902026-03-12Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, ZINC OXIDENice-Pak Products, LLCc370ee1f-1887-44e8-8d47-8ffa3c270ff52026-03-12Warnings, Adverse reactionsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMNice-Pak Products, LLC0b1a09b8-6499-4f41-836a-ad839c63f74f2026-03-12Warnings, Adverse reactionsExact identifier
application number: M016
Clear Anti-ItchPRAMOXINE HCL, ZINC ACETATENice-Pak Products, LLCb5b810b8-97c0-4ed5-bd30-17dc01e08d612026-03-12Warnings, Adverse reactionsExact identifier
application number: M016
Skin protectantPETROLATUMNice-Pak Products, LLC22202a9c-f2ba-4c65-a493-bf3240f474e72026-03-12Warnings, Adverse reactionsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039149dimethicone 3.2 % Medicated PadPSN81f0071b-2bf3-455b-9e5d-8f3ca20adcdf10
1039149dimethicone 32 MG/ML Medicated PadSCD81f0071b-2bf3-455b-9e5d-8f3ca20adcdf10
1039149dimethicone 3.2 % Medicated PadSY81f0071b-2bf3-455b-9e5d-8f3ca20adcdf10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-059-02533290059023 APPLICATOR in 1 PACKAGE (53329-059-02) > 17 mL in 1 APPLICATOR3 applicator2014-07-010000-00-00NoNoCurrent