FDA.reportPublic FDA data

Comfort Shield Barrier

Product NDC
53462-915
11-digit product format
534620915
Labeler code
53462
Product ID
53462-915_54ee06dc-1e51-3f8a-e063-6294a90a1fb0
Type
HUMAN OTC DRUG
Nonproprietary name
dimethicone
Dosage form
CLOTH
Route
TOPICAL
Labeler
Sage Products LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1990-01-01
Substance
DIMETHICONE
Active strength
30 mg/g
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53462-91553462-915-62DDiscontinued by firm2026-10-23
excluded packagepackage53462-91553462-915-81DDiscontinued by firm2026-10-23

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 13 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0553462-915-81d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0553462-915-62d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2653462-915-62f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3153462-915-622ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2853462-915-62a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2153462-915-62cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1053462-915-62cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3153462-915-62302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2053462-915-62ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1053462-915-620efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0853462-915-62ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0353462-915-62367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0953462-915-62557ba5c1ecfa…9c80585c8c6e…

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
Comfort Shield Barrier
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE30 mg/g

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
968663Internal RxNorm lookup
1088604Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cc08f571-84ae-4c2f-b09d-a83a8efc39f5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
53462-915-502022-02-22Comfort Shield Barrier Cream Cloths
53462-915-502022-02-22Comfort Shield Barrier Cream Cloths
53462-915-502022-02-22Comfort Shield Barrier Cream Cloths
53462-915-512022-02-22Comfort Shield Barrier Cream Cloths
53462-915-512022-02-22Comfort Shield Barrier Cream Cloths
53462-915-512022-02-22Comfort Shield Barrier Cream Cloths
53462-915-622022-02-22Comfort Shield Barrier Cream Cloths
53462-915-622022-02-22Comfort Shield Barrier Cream Cloths
53462-915-622022-02-22Comfort Shield Barrier Cream Cloths
53462-915-802022-02-22Comfort Shield Barrier Cream Cloths
53462-915-802022-02-22Comfort Shield Barrier Cream Cloths
53462-915-802022-02-22Comfort Shield Barrier Cream Cloths
53462-915-812022-02-22Comfort Shield Barrier Cream Cloths
53462-915-812022-02-22Comfort Shield Barrier Cream Cloths
53462-915-812022-02-22Comfort Shield Barrier Cream Cloths
53462-915-502022-01-28Comfort Shield Barrier Cream Cloths
53462-915-502022-01-28Comfort Shield Barrier Cream Cloths
53462-915-502022-01-28Comfort Shield Barrier Cream Cloths
53462-915-512022-01-28Comfort Shield Barrier Cream Cloths
53462-915-512022-01-28Comfort Shield Barrier Cream Cloths
53462-915-512022-01-28Comfort Shield Barrier Cream Cloths
53462-915-622022-01-28Comfort Shield Barrier Cream Cloths
53462-915-622022-01-28Comfort Shield Barrier Cream Cloths
53462-915-622022-01-28Comfort Shield Barrier Cream Cloths
53462-915-802022-01-28Comfort Shield Barrier Cream Cloths
53462-915-802022-01-28Comfort Shield Barrier Cream Cloths
53462-915-802022-01-28Comfort Shield Barrier Cream Cloths
53462-915-812022-01-28Comfort Shield Barrier Cream Cloths
53462-915-812022-01-28Comfort Shield Barrier Cream Cloths
53462-915-812022-01-28Comfort Shield Barrier Cream Cloths

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53462-915-24Comfort Shield Barrier24 g in 1 APPLICATORCLOTH2416
53462-915-24Comfort Shield Barrier24 in 1 PACKAGECLOTH2416
53462-915-50Comfort Shield Barrier26 g in 1 APPLICATORCLOTH2616
53462-915-50Comfort Shield Barrier3 in 1 PACKAGECLOTH316
53462-915-51Comfort Shield Barrier3 in 1 PACKAGECLOTH316
53462-915-51Comfort Shield Barrier19 g in 1 APPLICATORCLOTH1916
53462-915-62Comfort Shield Barrier24 g in 1 APPLICATORCLOTH2416
53462-915-62Comfort Shield Barrier24 in 1 PACKAGECLOTH2416
53462-915-80Comfort Shield Barrier27 g in 1 APPLICATORCLOTH2716
53462-915-80Comfort Shield Barrier8 in 1 PACKAGECLOTH816
53462-915-81Comfort Shield Barrier19 g in 1 APPLICATORCLOTH1916
53462-915-81Comfort Shield Barrier8 in 1 PACKAGECLOTH816

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53462-915-50EA - Each53462-91586d72459-ae42-4f14-82c1-9a3562488a1712012-07-24
53462-915-51EA - Each53462-9158f65a50a-b111-45b6-92fc-cb0281b4358312012-07-24
53462-915-60EA - Each53462-9155e281b48-6ba9-471a-a477-dd3fed32e90c12012-07-24
53462-915-80EA - Each53462-91525b8c726-486d-4f6d-bc84-a120976ca2bb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
dimethiconeACTIVE INGREDIENT92RU3N3Y1OCOMFORT SHIELD BARRIER (DIMETHICONE) CLOTH [SAGE PRODUCTS LLC]6
dimethiconeACTIVE MOIETY92RU3N3Y1OCOMFORT SHIELD BARRIER (DIMETHICONE) CLOTH [SAGE PRODUCTS LLC]6
aloe vera leafINACTIVE INGREDIENTZY81Z83H0XCOMFORT SHIELD BARRIER (DIMETHICONE) CLOTH [SAGE PRODUCTS LLC]6
chlorhexidine gluconateINACTIVE INGREDIENTMOR84MUD8ECOMFORT SHIELD BARRIER (DIMETHICONE) CLOTH [SAGE PRODUCTS LLC]6
glycerinINACTIVE INGREDIENTPDC6A3C0OXCOMFORT SHIELD BARRIER (DIMETHICONE) CLOTH [SAGE PRODUCTS LLC]6
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4COMFORT SHIELD BARRIER (DIMETHICONE) CLOTH [SAGE PRODUCTS LLC]6
hydroxyethyl cellulose (4000 MPA.S at 1%)INACTIVE INGREDIENTZYD53NBL45COMFORT SHIELD BARRIER (DIMETHICONE) CLOTH [SAGE PRODUCTS LLC]6
methylparabenINACTIVE INGREDIENTA2I8C7HI9TCOMFORT SHIELD BARRIER (DIMETHICONE) CLOTH [SAGE PRODUCTS LLC]6
PEG-100 stearateINACTIVE INGREDIENTYD01N1999RCOMFORT SHIELD BARRIER (DIMETHICONE) CLOTH [SAGE PRODUCTS LLC]6
PPG-15 STEARYL ETHERINACTIVE INGREDIENT1II18XLS1LCOMFORT SHIELD BARRIER (DIMETHICONE) CLOTH [SAGE PRODUCTS LLC]6
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHCOMFORT SHIELD BARRIER (DIMETHICONE) CLOTH [SAGE PRODUCTS LLC]6
stearic acidINACTIVE INGREDIENT4ELV7Z65APCOMFORT SHIELD BARRIER (DIMETHICONE) CLOTH [SAGE PRODUCTS LLC]6
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YCOMFORT SHIELD BARRIER (DIMETHICONE) CLOTH [SAGE PRODUCTS LLC]6
waterINACTIVE INGREDIENT059QF0KO0RCOMFORT SHIELD BARRIER (DIMETHICONE) CLOTH [SAGE PRODUCTS LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53462-915COMFORT SHIELD BARRIER (DIMETHICONE) CLOTH [SAGE PRODUCTS LLC]15Current NDC, Legacy NDC, 12 package rows20241120_cc08f571-84ae-4c2f-b09d-a83a8efc39f5.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 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quality Choice Anti-Itch ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEChain Drug Market Associatione3c0c46d-3d85-411d-a543-009064cdd19e2023-12-28WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists Therapeutic HandDIMETHICONEL'Oreal USA Products Inc7fe49112-4180-415c-a380-768a8d6b21852023-12-28WarningsExact identifier
application number: M016
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1088604Comfort Shield 3 % Medicated PadPSNcc08f571-84ae-4c2f-b09d-a83a8efc39f516
968663dimethicone 3 % Medicated PadPSNcc08f571-84ae-4c2f-b09d-a83a8efc39f516
1088604dimethicone 30 MG/ML Medicated Pad [Comfort Shield]SBDcc08f571-84ae-4c2f-b09d-a83a8efc39f516
968663dimethicone 30 MG/ML Medicated PadSCDcc08f571-84ae-4c2f-b09d-a83a8efc39f516
1088604Comfort Shield 3 % Medicated PadSYcc08f571-84ae-4c2f-b09d-a83a8efc39f516
1088604Comfort Shield 30 MG/ML Medicated PadSYcc08f571-84ae-4c2f-b09d-a83a8efc39f516
968663dimethicone 3 % Medicated PadSYcc08f571-84ae-4c2f-b09d-a83a8efc39f516
968663dimethicone 3 % WipeSYcc08f571-84ae-4c2f-b09d-a83a8efc39f516

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53462-915-245346209152424 APPLICATOR in 1 PACKAGE (53462-915-24) / 24 g in 1 APPLICATOR24 applicator2023-12-11NoNoCurrent
53462-915-50534620915503 APPLICATOR in 1 PACKAGE (53462-915-50) / 26 g in 1 APPLICATOR3 applicator1990-01-010000-00-00NoNoCurrent
53462-915-51534620915513 APPLICATOR in 1 PACKAGE (53462-915-51) / 19 g in 1 APPLICATOR3 applicator1990-01-010000-00-00NoNoCurrent
53462-915-625346209156224 APPLICATOR in 1 PACKAGE (53462-915-62) > 24 g in 1 APPLICATOR24 applicator1990-01-010000-00-00NoNoCurrent
53462-915-80534620915808 APPLICATOR in 1 PACKAGE (53462-915-80) / 27 g in 1 APPLICATOR8 applicator1990-01-010000-00-00NoNoCurrent
53462-915-81534620915818 APPLICATOR in 1 PACKAGE (53462-915-81) > 19 g in 1 APPLICATOR8 applicator1990-01-010000-00-00NoNoCurrent