FDA.reportPublic FDA data

Daily Moisturizing

Product NDC
36800-619
11-digit product format
368000619
Labeler code
36800
Product ID
36800-619_4ab9a518-a4b1-4f35-e063-6294a90a043c
Type
HUMAN OTC DRUG
Nonproprietary name
Dimethicone
Dosage form
LOTION
Route
TOPICAL
Labeler
Topco Associates LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-09-03
Substance
DIMETHICONE
Active strength
13.13 mg/mL
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Daily Moisturizing
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE13.13 mg/mL

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
891710Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
47e54eee-70e0-4bfa-ae77-d61a6560a9e1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-619-40Daily Moisturizing354 mL in 1 BOTTLE, PUMPLOTION35416
36800-619-44Daily Moisturizing532 mL in 1 BOTTLE, PUMPLOTION53216

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1ODAILY MOISTURIZING (DIMETHICONE) LOTION [TOPCO ASSOCIATES LLC]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1ODAILY MOISTURIZING (DIMETHICONE) LOTION [TOPCO ASSOCIATES LLC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHDAILY MOISTURIZING (DIMETHICONE) LOTION [TOPCO ASSOCIATES LLC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNDAILY MOISTURIZING (DIMETHICONE) LOTION [TOPCO ASSOCIATES LLC]1
DISTEARYLDIMONIUM CHLORIDEINACTIVE INGREDIENTOM9573ZX3XDAILY MOISTURIZING (DIMETHICONE) LOTION [TOPCO ASSOCIATES LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDAILY MOISTURIZING (DIMETHICONE) LOTION [TOPCO ASSOCIATES LLC]1
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MDAILY MOISTURIZING (DIMETHICONE) LOTION [TOPCO ASSOCIATES LLC]1
OATMEALINACTIVE INGREDIENT8PI54V663YDAILY MOISTURIZING (DIMETHICONE) LOTION [TOPCO ASSOCIATES LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XDAILY MOISTURIZING (DIMETHICONE) LOTION [TOPCO ASSOCIATES LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RDAILY MOISTURIZING (DIMETHICONE) LOTION [TOPCO ASSOCIATES LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-619DAILY MOISTURIZING (DIMETHICONE) LOTION [TOPCO ASSOCIATES LLC]15Current NDC, Legacy NDC, 2 package rows20250406_47e54eee-70e0-4bfa-ae77-d61a6560a9e1.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 60 of 68 · 1,346 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calamine ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONCardinal Health, 110 dba Leader7f733c0a-82b2-d3b0-e053-2991aa0a6b0f2024-05-13WarningsExact identifier
application number: M016
Walgreens Maximum Diaper RashZINC OXIDEWalgreens Company5eb2152f-6fa2-4191-878a-207416e698182024-05-07WarningsExact identifier
application number: M016
Cetaphil Eczema Rapid Relief CreamCOLLOIDAL OATMEALGalderma Laboratories, L.P.02a405fa-8ae9-41e9-b86f-ef5fb6e3844a2024-05-02WarningsExact identifier
application number: M016
ChapstickAVOBENZONE, OCTINOXATE, AND WHITE PETROLATUMHaleon US Holdings LLC0e34fc74-772e-48fd-a353-58807ef412c12024-05-01WarningsExact identifier
application number: M016
Diaper Rash Cream 40% ZINCZINC OXIDEASTONEA LABS PRIVATE LIMITED16da985a-6210-ec82-e063-6294a90a132d2024-04-24WarningsExact identifier
application number: M016
Petrolatum JellyPETROLATUMASTONEA LABS PRIVATE LIMITED16dac8e5-aeb8-592d-e063-6394a90ae2b62024-04-24WarningsExact identifier
application number: M016
Monistat Complete Care Chafing ReliefDIMETHICONEInsight Pharmaceuticals LLC07d7c883-1fa3-4786-905c-a1fab649765e2024-04-19WarningsExact identifier
application number: M016
zinc oxide 20%ZINC OXIDE 20%Bionpharma Inc1549500a-0941-0fba-e063-6394a90a564e2024-04-18WarningsExact identifier
application number: M016
ARC Skin ProtectantALLANTOINAnjon Biologics, Incf4ff79dd-cb38-4cca-9631-a2758a1718732024-04-18WarningsExact identifier
application number: M016
ZinctralZINC OXIDEPureTek Corporationde990834-00da-0c7a-e053-2995a90a7c372024-04-15WarningsExact identifier
application number: M016
Chapstick Moisturizer Variety PackAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUMHaleon US Holdings LLCbfb9a2d5-1ad2-45b8-a215-9d1370af53372024-04-12WarningsExact identifier
application number: M016
ChapStick Classic SpearmintPETROLATUMHaleon US Holdings LLCd39786e8-bcd8-479d-8990-142a21788a472024-04-12WarningsExact identifier
application number: M016
Chapstick 12 Days of ChristmasWHITE PETROLATUMHaleon US Holdings LLCd6eb2ea6-27c7-40a6-a1f0-789ea2131de32024-04-11WarningsExact identifier
application number: M016
Chapstick Active 2in1 Variety PackZINC OXIDEHaleon US Holdings LLCd1998a9e-d61f-4b4c-91b0-5e66754bcc4a2024-04-11WarningsExact identifier
application number: M016
Chapstick 12 Days of ChristmasWHITE PETROLATUMHaleon US Holdings LLC040694f0-b5ba-4203-bde9-699fa9b1afef2024-04-11WarningsExact identifier
application number: M016
Chapstick Holiday Classics KitWHITE PETROLATUMHaleon US Holdings LLC6df216dc-c03d-463a-8029-5e54c1dc3d272024-04-11WarningsExact identifier
application number: M016
Carmex Classic Lip Balm Medicated SPF15 Triple Force FormulaOCTINOXATE, OXYBENZONE, WHITE PETROLATUMCarma Laboratories, Inc.3eb0f8ff-89e7-4410-8573-3349e49465482024-04-02WarningsExact identifier
application number: M016
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
application number: M016
ChapStick Supreme Classic CherryWHITE PETROLATUMHaleon US Holdings LLC84d8cc38-83e3-49be-b180-d01820525b602024-03-22WarningsExact identifier
application number: M016
Chapstick Moisturizer OriginalAVOBENZONE, OCTINOXATE, AND WHITE PETROLATUMHaleon US Holdings LLC9cd13fbb-887f-46a8-9f0b-4450ad3e07b72024-03-22WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891710dimethicone 1.3 % Topical LotionPSN47e54eee-70e0-4bfa-ae77-d61a6560a9e116
891710dimethicone 13 MG/ML Topical LotionSCD47e54eee-70e0-4bfa-ae77-d61a6560a9e116
891710dimethicone 1.3 % Topical LotionSY47e54eee-70e0-4bfa-ae77-d61a6560a9e116

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-619-4036800061940354 mL in 1 BOTTLE, PUMP (36800-619-40) 354 ml2010-09-030000-00-00NoNoCurrent
36800-619-4436800061944532 mL in 1 BOTTLE, PUMP (36800-619-44) 532 ml2010-09-030000-00-00NoNoCurrent