Medline

Product NDC
53329-149
Requested package NDC
53329-149-86
11-digit product format
533290149
Labeler code
53329
Product ID
53329-149_5afb3595-f015-153e-e063-6294a90ad34b
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
2025-06-01
Marketing end
2027-06-01
Substance
DIMETHICONE
Active strength
1.575 g/100mL
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE1.575 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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5afb3595-f014-153e-e063-6294a90ad34bAvailable on FDA.report

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 44 of 68 · 1,346 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hania Skin ProtectantPETROLATUMNatureplex LLC63609a57-91fc-4cfd-b942-b69a0d2fb2842025-02-19WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELWhole Foods Market2c55ca28-61b1-4b3a-bba8-11acd1273bd32025-02-19WarningsExact identifier
application number: M016
DERMASIL DRYSKINDIMETHICONEFantasia Beauty LLC8a49f4be-8a73-41ca-86f4-11a707b2987a2025-02-18WarningsExact identifier
application number: M016
Aveeno Baby Eczema Therapy Moisturizing Cream ClubtrayCOLLOIDAL OATMEALKenvue Brands LLC2e04acfe-5934-dc4e-e063-6294a90ab9e62025-02-13WarningsExact identifier
application number: M016
Aveeno Baby Eczema Therapy MoisturizingOATMEALKenvue Brands LLC2e07e83c-22dc-d644-e063-6294a90a68332025-02-13WarningsExact identifier
application number: M016
XtraCare Oatmeal Daily Moisturizing 8 ozDIMETHICONERejoice International Inc.c055d5fb-7398-26e4-e053-2995a90acd412025-02-13WarningsExact identifier
application number: M016
XtraCare Oatmeal Daily Moisturizing 8 ozDIMETHICONERejoice International Inc.c0670819-830e-4082-e053-2a95a90adadc2025-02-13WarningsExact identifier
application number: M016
Alike Daily MoisturizingDIMETHICONERejoice International Inc.71b07d46-ff5b-b5ae-e053-2a95a90a8e712025-02-12WarningsExact identifier
application number: M016
Witch Hazel ReadyInCaseWITCH HAZELP & L Development, LLC1588244a-c9e8-4a04-b605-10e35c225e6c2025-02-12WarningsExact identifier
application number: M016
XtraCare Creamy Petroleum JellyPETROLATUMRejoice International6b765967-aead-4f6d-98ee-fac381a40a6e2025-02-11WarningsExact identifier
application number: M016
XtraCare Creamy Petroleum JellyPETROLATUMRejoice Internationaldf367223-b004-42ac-ab3d-23809ebef1b02025-02-11WarningsExact identifier
application number: M016
XtraCare with cooling action Oatmeal Skin Relief CalminDIMETHICONERejoice Internationalf99606f6-83bc-436e-aa21-53e77eb87b9c2025-02-09WarningsExact identifier
application number: M016
Aluroderm ScarALLANTOINOlakino Therapeutics LLC2a848dde-8fc4-ab10-e063-6294a90a25832025-02-07WarningsExact identifier
application number: M016
Meijer Scar GelALLANTOIN 0.5%Meijerc79352e9-d9a3-0d42-e053-2a95a90a5ea22025-02-06WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELFamily Dollar (FAMILY WELLNESS)a2047ef3-cda4-4411-a4c2-d7fb03f5b0692025-02-06WarningsExact identifier
application number: M016
First honey Burn SalveALLANTOINFirst Honey, LLCf40a9a34-1827-7171-e053-2a95a90acf312025-02-04WarningsExact identifier
application number: M016
Manuka Honey Extra StrengthALLANTOINFirst Honey LLCb742585d-9a0c-489b-b268-590583cfabd12025-02-04WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELCardinal Health (Leader) 7000036deb7de-14b0-44a4-89bb-51cc1770e65b2025-02-04WarningsExact identifier
application number: M016
NIVAGEN ZINC OXIDEZINC OXIDENivagen Pharmaceuticals, Inc.7b42655b-2163-4637-9f5d-1d2efa1bdf1d2025-02-03WarningsExact identifier
application number: M016
MATYS Baby ECZEMA RELIEFCOLLOIDAL OATMEALMatys Healthy Products LLC4c052bed-0931-4b8d-b033-b1872272c5982025-01-29WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-149-8653329014986946 mL in 1 BOTTLE (53329-149-86) 946 ml2025-06-012027-06-01NoNoHistorical