Comfort Shield Barrier

Product NDC
53462-915
11-digit product format
534620915
Labeler code
53462
Product ID
53462-915_419e18cd-fa52-b78d-e063-6294a90a467c
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Comfort Shield Barrier
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE30 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui968663, 1088604

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53462-915-502022-02-22C16284748780-1d6a99b39-4a60-a426-e053-dadaa90af4c2Comfort Shield Barrier Cream Cloths
53462-915-502022-02-22C16284748780-1d6a99b39-4a60-a426-e053-dadaa90af4c2Comfort Shield Barrier Cream Cloths
53462-915-512022-02-22C16284748780-1d6a99b39-4a60-a426-e053-dadaa90af4c2Comfort Shield Barrier Cream Cloths
53462-915-512022-02-22C16284748780-1d6a99b39-4a60-a426-e053-dadaa90af4c2Comfort Shield Barrier Cream Cloths
53462-915-622022-02-22C16284748780-1d6a99b39-4a60-a426-e053-dadaa90af4c2Comfort Shield Barrier Cream Cloths
53462-915-622022-02-22C16284748780-1d6a99b39-4a60-a426-e053-dadaa90af4c2Comfort Shield Barrier Cream Cloths
53462-915-802022-02-22C16284748780-1d6a99b39-4a60-a426-e053-dadaa90af4c2Comfort Shield Barrier Cream Cloths
53462-915-802022-02-22C16284748780-1d6a99b39-4a60-a426-e053-dadaa90af4c2Comfort Shield Barrier Cream Cloths
53462-915-812022-02-22C16284748780-1d6a99b39-4a60-a426-e053-dadaa90af4c2Comfort Shield Barrier Cream Cloths
53462-915-812022-02-22C16284748780-1d6a99b39-4a60-a426-e053-dadaa90af4c2Comfort Shield Barrier Cream Cloths
53462-915-502022-01-28C16284748780-1d6a99b39-4a60-a426-e053-dadaa90af4c2Comfort Shield Barrier Cream Cloths
53462-915-502022-01-28C16284748780-1d6a99b39-4a60-a426-e053-dadaa90af4c2Comfort Shield Barrier Cream Cloths
53462-915-512022-01-28C16284748780-1d6a99b39-4a60-a426-e053-dadaa90af4c2Comfort Shield Barrier Cream Cloths
53462-915-512022-01-28C16284748780-1d6a99b39-4a60-a426-e053-dadaa90af4c2Comfort Shield Barrier Cream Cloths
53462-915-622022-01-28C16284748780-1d6a99b39-4a60-a426-e053-dadaa90af4c2Comfort Shield Barrier Cream Cloths
53462-915-622022-01-28C16284748780-1d6a99b39-4a60-a426-e053-dadaa90af4c2Comfort Shield Barrier Cream Cloths
53462-915-802022-01-28C16284748780-1d6a99b39-4a60-a426-e053-dadaa90af4c2Comfort Shield Barrier Cream Cloths
53462-915-802022-01-28C16284748780-1d6a99b39-4a60-a426-e053-dadaa90af4c2Comfort Shield Barrier Cream Cloths
53462-915-812022-01-28C16284748780-1d6a99b39-4a60-a426-e053-dadaa90af4c2Comfort Shield Barrier Cream Cloths
53462-915-812022-01-28C16284748780-1d6a99b39-4a60-a426-e053-dadaa90af4c2Comfort 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

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 applicator2023-12-11NoNoHistorical
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