FDA.reportPublic FDA data

AFTER CARE

Product NDC
46783-004
11-digit product format
467830004
Labeler code
46783
Product ID
46783-004_a798a2c8-31dc-4810-a3c4-57756643c2cd
Type
HUMAN OTC DRUG
Nonproprietary name
DIMETHICONE
Dosage form
CREAM
Route
TOPICAL
Labeler
Merz North America
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-04-01
Substance
DIMETHICONE
Active strength
4 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
AFTER CARE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE4 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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c19c5ffe-3b62-43e1-83c2-d89c7b9aa2aeAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46783-004-04AFTER CARE4 mL in 1 TUBECREAM48
46783-004-15AFTER CARE1 in 1 CARTONCREAM18
46783-004-15AFTER CARE15 mL in 1 BOTTLECREAM158
46783-004-20AFTER CARE1 in 1 CARTONCREAM18
46783-004-20AFTER CARE200 mL in 1 BOTTLECREAM2008
46783-004-30AFTER CARE1 in 1 CARTONCREAM18
46783-004-30AFTER CARE30 mL in 1 BOTTLECREAM308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46783-004AFTER CARE (DIMETHICONE) CREAM [MERZ NORTH AMERICA]7Current NDC, Legacy NDC, 7 package rows20241109_c19c5ffe-3b62-43e1-83c2-d89c7b9aa2ae.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 58 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
insect bite relief 01MENTHOLCosmuses Cosmetics (Ningbo) Co., Ltd.006e457d-bfcd-791a-e063-6294a90a8d662024-09-23WarningsExact identifier
application number: M016
daburZINC OXIDEDabur India Limited22cd1e7a-5448-b3f6-e063-6394a90a880d2024-09-23WarningsExact identifier
application number: M016
DABUR Vitamin A and DWHITE PETROLATUMDabur India Limited22cd44ef-4b02-604d-e063-6394a90a7a0a2024-09-23WarningsExact identifier
application number: M016
DABUR ZINC OXIDE 3.8%ZINC OXIDEDabur India Limited2290bbe2-8a88-b94e-e063-6294a90a7e382024-09-20WarningsExact identifier
application number: M016
Aveeno Baby Daily MoistureDIMETHICONEKenvue Brands LLCb34c8e71-7fad-484c-b387-3c424f50b7432024-09-19WarningsExact identifier
application number: M016
Evereden Intensive Eczema BalmCOLLOIDAL OATMEALEden Brands Inc.2243d4ca-5ca4-54d0-e063-6394a90a39402024-09-16WarningsExact identifier
application number: M016
Whipped GelCOLLOIDAL OATMEALOCEAN OLIVE LLC222b381c-665e-177d-e063-6394a90a33062024-09-15WarningsExact identifier
application number: M016
BioBarrier Renewal CreamALLANTOINbluemercury1ee15f84-0561-3cd2-e063-6394a90ab68e2024-09-15WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEStrategic Sourcing Services, LLC22173332-9d09-768c-e063-6394a90a94e12024-09-14WarningsExact identifier
application number: M016
Diaper Rash Cream 5.6ozZINC OXIDEChina Ningbo Shangge Cosmetics Technology Corp.21a7c4ce-1360-931c-e063-6294a90aa66d2024-09-11WarningsExact identifier
application number: M016
Healing Cream 3ozPETROLATUMChina Ningbo Shangge Cosmetics Technology Corp.21bdbb13-cc64-b5d7-e063-6294a90ae3fd2024-09-11WarningsExact identifier
application number: M016
Healing Cream15ozPETROLATUMRejoice International Corp.21e4026c-d3da-e4f7-e063-6394a90aabed2024-09-11WarningsExact identifier
application number: M016
Baby Balm Stick 0.65ozPETROLATUM OINTMENTChina Ningbo Shangge Cosmetics Technology Corp.21c0b614-ea19-e98d-e063-6294a90ac44e2024-09-10WarningsExact identifier
application number: M016
Aveeno Skin Relief Moisturizing Fragrance FreeDIMETHICONEKenvue Brands LLC65476a2a-8cd4-4477-ac27-9a06f41e47112024-09-09WarningsExact identifier
application number: M016
Diaper Rash Cream 15ozZINC OXIDERejoice International Corp.213213ab-f935-a62e-e063-6394a90af96b2024-09-03WarningsExact identifier
application number: M016
Diaper Rash Cream 5.6ozZINC OXIDERejoice International Corp.2133876b-eaf0-f988-e063-6394a90aae4d2024-09-03WarningsExact identifier
application number: M016
Baby Balm Stick 0.65ozPETROLATUMRejoice International Corp.20cf3bb8-4ab8-2980-e063-6294a90ad6312024-08-29WarningsExact identifier
application number: M016
SUDOCREM SKIN PROTECTANTZINC OXIDELEDA INNOVATIONS USA, INC.20d2cf0b-d237-fd78-e063-6394a90a8d032024-08-29WarningsExact identifier
application number: M016
Healing Cream 3ozPETROLATUMRejoice International Corp.20c9b964-c9af-d63a-e063-6294a90ab9792024-08-28WarningsExact identifier
application number: M016
Babyganics Soothing ItchOATMEALKAS Direct, LLC5c2806fb-5af4-4532-b31a-be77bb23b2772024-08-28WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46783-004-04467830004044 mL in 1 TUBE (46783-004-04) 4 ml2019-06-110000-00-00NoNoCurrent
46783-004-15467830004151 BOTTLE in 1 CARTON (46783-004-15) / 15 mL in 1 BOTTLE1 bottle2019-04-010000-00-00NoNoCurrent
46783-004-20467830004201 BOTTLE in 1 CARTON (46783-004-20) / 200 mL in 1 BOTTLE1 bottle2019-04-010000-00-00NoNoCurrent
46783-004-30467830004301 BOTTLE in 1 CARTON (46783-004-30) / 30 mL in 1 BOTTLE1 bottle2023-10-02NoNoCurrent