SENSI-CARE BODY

Product NDC
43553-0002
Requested package NDC
43553-0002-3
11-digit product format
435530002
Labeler code
43553
Product ID
43553-0002_b35a7d96-c0fc-730a-e053-2995a90ac80c
Type
HUMAN OTC DRUG
Nonproprietary name
PETROLATUM, DIMETHICONE
Dosage form
CREAM
Route
TOPICAL
Labeler
ConvaTec Inc.
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-12-20
Marketing end
2022-06-03
Substance
PETROLATUM; DIMETHICONE
Active strength
30 g/100g; g/100g
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage43553-000243553-0002-3DDiscontinued by firm2026-10-05

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43553-0002-3GM - Gram43553-0002bd370168-0aa8-44e9-8d89-e95b98edf80f12016-06-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OSENSI-CARE BODY (PETROLATUM, DIMETHICONE) CREAM [CONVATEC INC.]1
PETROLATUMACTIVE INGREDIENT4T6H12BN9USENSI-CARE BODY (PETROLATUM, DIMETHICONE) CREAM [CONVATEC INC.]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1OSENSI-CARE BODY (PETROLATUM, DIMETHICONE) CREAM [CONVATEC INC.]1
PETROLATUMACTIVE MOIETY4T6H12BN9USENSI-CARE BODY (PETROLATUM, DIMETHICONE) CREAM [CONVATEC INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSENSI-CARE BODY (PETROLATUM, DIMETHICONE) CREAM [CONVATEC INC.]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4SENSI-CARE BODY (PETROLATUM, DIMETHICONE) CREAM [CONVATEC INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSENSI-CARE BODY (PETROLATUM, DIMETHICONE) CREAM [CONVATEC INC.]1
LAURETH-23INACTIVE INGREDIENTN72LMW566GSENSI-CARE BODY (PETROLATUM, DIMETHICONE) CREAM [CONVATEC INC.]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCSENSI-CARE BODY (PETROLATUM, DIMETHICONE) CREAM [CONVATEC INC.]1
MAGNESIUM CHLORIDEINACTIVE INGREDIENT02F3473H9OSENSI-CARE BODY (PETROLATUM, DIMETHICONE) CREAM [CONVATEC INC.]1
MAGNESIUM NITRATEINACTIVE INGREDIENT77CBG3UN78SENSI-CARE BODY (PETROLATUM, DIMETHICONE) CREAM [CONVATEC INC.]1
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNSENSI-CARE BODY (PETROLATUM, DIMETHICONE) CREAM [CONVATEC INC.]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFASENSI-CARE BODY (PETROLATUM, DIMETHICONE) CREAM [CONVATEC INC.]1
PROPYLENEINACTIVE INGREDIENTAUG1H506LYSENSI-CARE BODY (PETROLATUM, DIMETHICONE) CREAM [CONVATEC INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SENSI-CARE BODY (PETROLATUM, DIMETHICONE) CREAM [CONVATEC INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISENSI-CARE BODY (PETROLATUM, DIMETHICONE) CREAM [CONVATEC INC.]1
STEARETH-2INACTIVE INGREDIENTV56DFE46J5SENSI-CARE BODY (PETROLATUM, DIMETHICONE) CREAM [CONVATEC INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSENSI-CARE BODY (PETROLATUM, DIMETHICONE) CREAM [CONVATEC INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43553-0002-34355300020385 g in 1 TUBE (43553-0002-3) 85 g2013-12-202022-06-03NoNoCurrent