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 55 of 68 · 1,346 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Avene XERACALM Eczema Calming Relief BalmCOLLOIDAL OATMEALPierre Fabre USA Inc.1315f006-0e96-2074-e063-6394a90a60372024-11-06WarningsExact identifier
application number: M016
Aveeno Baby Daily Moisture with Coconut Oil and Shea ButterDIMETHICONEKenvue Brands LLCeb71f8b1-bbcd-f338-e053-2995a90a80f12024-11-05WarningsExact identifier
application number: M016
Aveeno Eczema Therapy Daily MoisturizingCOLLOIDAL OATMEALKenvue Brands LLCe4c85780-7cb2-b55c-e053-2995a90a03142024-11-05WarningsExact identifier
application number: M016
Aveeno Baby Daily Care SetDIMETHICONEKenvue Brands LLC62025bfa-245e-4369-9949-d31ea455ad312024-11-05WarningsExact identifier
application number: M016
Aveeno Baby Continuous Protection Sensitive Skin Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLCf2fd12cf-45c0-163f-e053-2a95a90ad4592024-11-05WarningsExact identifier
application number: M016
Aveeno Baby Daily Care SetDIMETHICONEKenvue Brands LLC3d3da49e-dba6-4c6b-9278-5c8692e29f142024-11-05WarningsExact identifier
application number: M016
Aveeno Eczema Therapy Itch Relief BalmOATMEALKenvue Brands LLCbab3b767-864c-4c9f-b812-4fbd2bf2ca772024-11-05WarningsExact identifier
application number: M016
Aveeno Skin Relief Moisturizing Fragrance FreeDIMETHICONEKenvue Brands LLC1bad1069-b169-4bc9-8eb8-5123d57f74e52024-11-05WarningsExact identifier
application number: M016
Aveeno Skin Relief Moisturizing Fragrance FreeDIMETHICONEKenvue Brands LLCe0d9b055-be7a-8bba-e053-2995a90ab9e32024-11-05WarningsExact identifier
application number: M016
Aveeno Eczema Therapy daily moisturizingOATMEALKenvue Brands LLCdcbdb2ce-3877-41ea-9978-986e17a7c8772024-11-05WarningsExact identifier
application number: M016
Aveeno Baby Daily MoistureDIMETHICONEKenvue Brands LLC3879110f-ba83-446b-b580-f8eaa859789d2024-11-05WarningsExact identifier
application number: M016
Aveeno Daily MoisturizingDIMETHICONEKenvue Brands LLC70593b0c-c41b-4294-9bfa-42003ba1e3e42024-11-05WarningsExact identifier
application number: M016
Aveeno Baby Calming ComfortDIMETHICONEKenvue Brands LLC029fbae2-06ad-4fe9-b542-834686c5cb972024-11-05WarningsExact identifier
application number: M016
Aveeno Skin Relief OvernightDIMETHICONEKenvue Brands LLCe7da6c9c-d6b0-4dc5-bfa4-68345f9c2d3c2024-11-05WarningsExact identifier
application number: M016
Quality Choice Diaper RashZINC OXIDEChain Drug Marketing Association Inc.262e7eac-4b44-f224-e063-6394a90a4f592024-11-05WarningsExact identifier
application number: M016
Zinc Oxide 20%ZINC OXIDEChain Drug Marketing Association Inc.262f8cab-c7b8-b07e-e063-6294a90a12892024-11-05WarningsExact identifier
application number: M016
ECZEMAOATMEALORGANIC & SUSTAINABLE BEAUTY926706b5-0a08-4604-b5ad-3b3ddfd7f02d2024-11-05WarningsExact identifier
application number: M016
Walgreens Eczema Relief Body Skin ProtectantOATMEALWalgreen Companyb2eebc2f-addd-4822-b224-04bd5f4506532024-11-05WarningsExact identifier
application number: M016
ECZEMAOATMEALORGANIC & SUSTAINABLE BEAUTY81eb3df4-5beb-45aa-82ca-e8b4b37e45f42024-11-05Warnings, Adverse reactionsExact identifier
application number: M016
Aveeno Baby Calming ComfortDIMETHICONEKenvue Brands LLC567b1481-b783-45f9-af38-5630c9edf0442024-11-01WarningsExact 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