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 24 of 69 · 1,363 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pure Petrolatum JellyPETROLATUMMY IMPORTS USA LLC47da77ea-ab4e-fc3c-e063-6394a90a27b72026-01-08WarningsExact identifier
application number: M016
Z-BumDIAPER RASH CREAMGM Pharmaceuticals, Inc2a36f396-3a30-3f3f-e054-00144ff8d46c2026-01-08WarningsExact identifier
application number: M016
Daily VLotionDIMETHICONEKindra1cc4b804-6483-68fd-e063-6294a90a38e42026-01-08WarningsExact identifier
application number: M016
V Relief SerumDIMETHICONEKindra1cd8a9e9-ac88-1799-e063-6294a90a32782026-01-08WarningsExact identifier
application number: M016
DR SMITHS DIAPERZINC OXIDEMission Pharmacal7705b182-acf7-4195-9996-7d9fcdfbf0552026-01-08WarningsExact identifier
application number: M016
DERMATITIS FACE BALMCOLLOIDAL OATMEALSkinfix, Inc.86d2db7d-f1d4-4bca-aba4-d4c96b83c1a62026-01-08WarningsExact identifier
application number: M016
First Aid Beauty Dry Skin Rescue Kit 5x Hydration PowerCOLLOIDAL OATMEALJCS Global Distribution, Inc.47d06283-21cd-4a69-e063-6294a90adb052026-01-07WarningsExact identifier
application number: M016
DE LA CRUZ DIAPER RASHALLANTOIN, PETROLATUM, AND ZINC OXIDEDLC Laboratories, Inc.5949aa0f-a7cb-453c-81fd-9fa24653a4522026-01-07WarningsExact identifier
application number: M016
Thera Wise Natural HemorrhoidalWITCH HAZELDerma Wise Skin Care Ltd.a29fb680-cfc8-4a7b-9970-563fa0e2bed62026-01-06WarningsExact identifier
application number: M016
Sky and Sol SPF25 Lip BalmSKY AND SOL SPF25 LIP BALMGuangzhou Fantesy Biotechnology Co.,Ltd1f37c0c3-6443-60a3-e063-6394a90a596f2026-01-05WarningsExact identifier
application number: M016
Remedy EssentialsWHITE PETROLATUM,ZINC OXIDEMedline Industries, LP42a033d6-782b-2d7f-e054-00144ff8d46c2026-01-05WarningsExact identifier
application number: M016
BUNUSS Estriol FaceESTRIOLJiashen International Trade Limited478b5690-038a-ba1c-e063-6394a90a3ad62026-01-04WarningsExact identifier
application number: M016
Skin Protectant for Babies and kidsSKIN PROTECTANT OINTMENTNeilmed Pharmaceuticals Inc.448b70db-ca81-db7b-e063-6294a90a5f0d2026-01-02WarningsExact identifier
application number: M016
Puriya Eczema CreamCOLLOIDAL OATMEALIPC Republic, Inc.24ac044e-13fa-5ff6-e063-6294a90a99852026-01-01WarningsExact identifier
application number: M016
ScarzenDIMETHICONEVillage Pharma LLC1550f4e5-22e2-491f-8184-de65da7234e62026-01-01WarningsExact identifier
application number: M016
Olay Ultimate Sensitive Colloidal Oatmeal Skin Protectant Moisturizer Fragrance FreeCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company1fa6282a-172e-f5c8-e063-6294a90a4fb12025-12-31WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Vanilla LatteCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company27713ae6-b428-e0d7-e063-6394a90a7a892025-12-31WarningsExact identifier
application number: M016
Eucerin Eczema Relief BodyOATMEALBeiersdorf Inc9895f3c3-b00b-462c-ace0-696d688e2e042025-12-31WarningsExact identifier
application number: M016
Eucerin Eczema Relief Flare Up TreatmentOATMEALBeiersdorf Inca9ea4832-3211-40b2-accf-90ace7b9e2792025-12-31WarningsExact identifier
application number: M016
Eczema Relief Cream Body WashOATMEALBeiersdorf Incf12644e5-0ff0-de0e-e053-2995a90a09952025-12-31WarningsExact 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