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 63 of 68 · 1,346 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEPharma Nobis, LLCe42fccc2-1b4e-e7f3-e053-2a95a90aef392023-12-26WarningsExact identifier
application number: M016
Calamine Phenolated Topical SuspensionCALAMINE AND ZINC OXIDE AND PHENOLPharma Nobis, LLCe42fbdcc-3291-7761-e053-2995a90a71722023-12-26WarningsExact identifier
application number: M016
Humco CalagesicCALAMINE AND PRAMOXINE HYDROCHLORIDEPharma Nobis, LLCe42fb807-8cb4-ed25-e053-2995a90a67802023-12-26WarningsExact identifier
application number: M016
Leader Calamine PlusZINC OXIDE LOTIONCardinal Health, 110 dba Leader81f29789-f794-1e64-e053-2a91aa0ac85e2023-12-22WarningsExact identifier
application number: M016
CVS Calamine PlusZINC OXIDECVS Pharmacyb90cd214-d44a-4458-876d-59cc0795226d2023-12-22WarningsExact identifier
application number: M016
CalamineCALAMINE 8% AND ZINC OXIDE 8%Pharma Nobis, LLCe42f0bd6-3ad3-7e07-e053-2995a90a564a2023-12-22WarningsExact identifier
application number: M016
DDM CalamineCALAMINE 8% AND ZINC OXIDE 8%Discount Drug Mart5d53685b-ca4c-35c1-e053-2a91aa0aff6e2023-12-20WarningsExact identifier
application number: M016
DDM CalagesicZINC ACETATE AND PRAMOXINE HYDROCHLORIDEDiscount Drug Mart5d537a11-049e-0a8d-e053-2a91aa0aa0c32023-12-20WarningsExact identifier
application number: M016
Health Mart CalamineCALAMINE 8% AND ZINC OXIDE 8%Strategic Sourcing Services LLC349ea07d-79bc-46f3-9d60-85b40db51bbb2023-12-20WarningsExact identifier
application number: M016
Health Mart Witch HazelWITCH HAZELStrategic Sourcing Services LLC2a1d9b27-0bd4-4475-8218-ba0f5560a9692023-12-20WarningsExact identifier
application number: M016
Quality Choice CalamineCALAMINE 8% AND ZINC OXIDE 8%Chain Drug Market Association62fe653f-e861-472b-b193-4fdd9d25de8d2023-12-20WarningsExact identifier
application number: M016
Premier Value CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEChain Drug Consortium5c89e3ac-ca4d-ec3a-e053-2a91aa0a1c0b2023-12-20WarningsExact identifier
application number: M016
Best Choice Medicated CalamineZINC ACETATE AND PRAMOXINE HYDROCHLORIDEValu Merchandisers, CO.5d6c668a-80b4-de18-e053-2991aa0a38fb2023-12-20WarningsExact identifier
application number: M016
Premiere Value CalamineCALAMINE 8% AND ZINC OXIDE 8%Chain Drug Consortium5c8bde5a-591d-085f-e053-2991aa0a56af2023-12-20WarningsExact identifier
application number: M016
Best Choice Anti-Itch ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEValu Merchandisers, CO5d6c51b8-47f8-c38b-e053-2991aa0a0f232023-12-20WarningsExact identifier
application number: M016
Health Care CalamineCALAMINE 8% AND ZINC OXIDE 8%Great Lakes Wholesale, Marketing and Sales Inc5d8f02fb-0794-8ec2-e053-2991aa0aac632023-12-20WarningsExact identifier
application number: M016
Harris Teetter CalagesicZINC ACETATE AND PRAMOXINE HYDROCHLORIDEHarris Tetter, LLC.5c7a7418-c973-2869-e053-2991aa0ab4f52023-12-20WarningsExact identifier
application number: M016
Harris Teeter CalamineZINC OXIDEHarris Teeter, LLC.86021cc5-fea7-4363-8fb2-2b0484437fe82023-12-20WarningsExact identifier
application number: M016
CVS Itch ReliefPRAMOXINE HYDROCHLORIDE AND ZINC ACETATECVS Pharmacyc60cfbf2-6788-43dc-b23a-e3433b7f32652023-12-20WarningsExact identifier
application number: M016
Sunmark CalamineCALAMINE 8% AND ZINC OXIDE 8%Strategic Sourcing Services LLCc7467f21-56cc-43ca-abfa-e62d35c8baa62023-12-19WarningsExact 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