Medline

Product NDC
53329-271
11-digit product format
533290271
Labeler code
53329
Product ID
53329-271_5afb59b4-491d-45bb-e063-6294a90a0ae6
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
2026-07-01
Marketing end
2028-06-30
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
5afb59b4-491c-45bb-e063-6294a90a0ae6Available 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 43 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Petroleum JellyWHITE PETROLATUM JELLYWALGREENS1fc9eecd-fd25-827c-e063-6394a90a26a52025-03-26WarningsExact identifier
application number: M016
Cocoa Butter Petroleum JellyWHITE PETROLATUM JELLYWALGREENS1fcc9626-6058-e9b3-e063-6394a90ab5252025-03-26WarningsExact identifier
application number: M016
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD313b08e2-d764-96da-e063-6294a90ab7052025-03-25WarningsExact identifier
application number: M016
Eczema CreamECZEMA CREAMKyte Baby LLC30c943aa-d9dc-5c16-e063-6294a90a3c582025-03-20WarningsExact identifier
application number: M016
Koala Kubs Diaper Rash CreamDIAPER RASH CREAMMelaleuca, Inc.c6b3b0dd-22a8-16f7-e053-2a95a90a51ea2025-03-20WarningsExact identifier
application number: M016
Gold Bond Eczema Relief Medicated Skin Protectant CreamCOLLOIDAL OATMEALChattem, Inc.2b6b8342-878d-4588-8b24-6746d35d319d2025-03-19WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Juicy PeachCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company30b20bd5-3b4f-8cc7-e063-6394a90a91062025-03-19WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Fresh StrawberryCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company30b2744d-fb59-f383-e063-6294a90abd2a2025-03-19WarningsExact identifier
application number: M016
Dr. Butler Hemorrhoid and PerinealMINERAL OIL 59.8%,PETROLATUM 36%Beyond Health P.A.d17b6f16-6893-ce0a-e053-2a95a90aa23a2025-03-19WarningsExact identifier
application number: M016
Gold Bond Diabetics Medicated Dry Skin Relief Foot CreamDIMETHICONE, WHITE PETROLATUMChattem, Inc.b951d1cb-b81e-4d7f-9a67-8405daa896672025-03-19WarningsExact identifier
application number: M016
Gold Bond Eczema Relief Medicated Hand CreamCOLLOIDAL OATMEALChattem, Inc.27457bc5-3edc-4c8b-b8a2-eaf09b511cf82025-03-19WarningsExact identifier
application number: M016
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD30a977c3-6862-670e-e063-6294a90aeb2f2025-03-18WarningsExact identifier
application number: M016
YVTYVT Copper Peptides Face SerumCOPPER TRIPEPTIDE-1Beijing JUNGE Technology Co., Ltd.306f2d48-43b8-359a-e063-6394a90a06dc2025-03-16Boxed warning, WarningsExact identifier
application number: M016
Dr Talbots Cooling Perineal PadWATER, ALOE BARBADENSIS LEAF JUICE, BIOFLAVONOIDS, CALENDULA OFFICINALIS FLOWER EXTRACT, CHAMOMILLA RECUTITA FLOWER EXTRACT, CITRIC ACID, DECYL GLUCOSIDE, GLYCERIN, LACTIC ACID, LEVULINIC ACID, MENTHA PIPERITA (PEPPERMINT) OIL, SODIUM COCOAMPHOACETATE, POTASSIUM SORBATETalbot's Pharmaceuticals family Products, LLC.242277e2-ff26-ad4e-e063-6394a90ab3172025-03-14WarningsExact identifier
application number: M016
RID Poison Ivy Rash ReliefCALAMINE AND ZINC OXIDEOystershell Consumer Health Inc.36c3af9a-2646-4427-e063-6394a90a2c5e2025-03-13WarningsExact identifier
application number: M016
Aavini Double Layer Brightening Spot Correcting Essence OilAAVINI DOUBLE LAYER BRIGHTENING SPOT CORRECTING ESSENCE OILQingyuan Moksha Biotechnology Co., Ltd.2ff89a13-3969-2df1-e063-6394a90ac0d32025-03-10WarningsExact identifier
application number: M016
5% Signature Numb cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD3008bbeb-abba-5cdb-e063-6294a90ae4832025-03-10WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Cucumber MelonCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company2fc4745c-fac9-7861-e063-6294a90a3f142025-03-07WarningsExact identifier
application number: M016
AD Skin ProtectantAD SKIN PROTECTANTWellSpring Pharmaceutical Corporationd26f1312-2e1b-4106-bc48-a336d4e034ad2025-03-07WarningsExact identifier
application number: M016
Aveeno Baby Eczema Therapy Nighttime BalmOATMEALKenvue Brands LLC04d90e45-c2ee-4122-b919-a0eb6d11b59a2025-03-04WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-271-4453329027144118 mL in 1 TUBE (53329-271-44) 118 ml2026-07-012028-06-30NoNoHistorical
53329-271-8653329027186946 mL in 1 TUBE (53329-271-86) 946 ml2026-07-012028-06-30NoNoHistorical