SENSI CARE CLEAR ZINC

Product NDC: 43553-0007
11-digit product format: 435530007
Labeler code: 43553
Product ID: 43553-0007_b35a3eac-f934-1e4a-e053-2995a90a3958
Type: HUMAN OTC DRUG
Nonproprietary name: DIMETHICONE, ZINC OXIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: ConvaTec Inc.
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-06-12
Marketing end: 2021-10-14
Substance: DIMETHICONE; ZINC OXIDE
Active strength: 5 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43553-0007		D	Discontinued by firm	2026-10-05
excluded package	package	43553-0007	43553-0007-2	D	Discontinued by firm	2026-10-05
excluded package	package	43553-0007	43553-0007-5	D	Discontinued by firm	2026-10-05

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43553-0007-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43553-0007-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43553-0007-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43553-0007-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43553-0007-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43553-0007-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43553-0007-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43553-0007-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43553-0007-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43553-0007-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43553-0007-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43553-0007-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43553-0007-5	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43553-0007-2	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43553-0007-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43553-0007-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43553-0007-5	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43553-0007-2	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43553-0007-5	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43553-0007-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43553-0007-5	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43553-0007-2	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43553-0007-5	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43553-0007-2	`557ba5c1ecfa…`	`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 NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43553-0007-2	GM - Gram	43553-0007	9a43c170-9ee5-498e-bc0a-e1fb71d76ac1	1	2018-01-12
43553-0007-5	GM - Gram	43553-0007	b67782ea-35b1-45be-af1f-0910461cf589	1	2018-01-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	SENSI CARE CLEAR ZINC (DIMETHICONE, ZINC OXIDE) CREAM [CONVATEC INC]	3
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	SENSI CARE CLEAR ZINC (DIMETHICONE, ZINC OXIDE) CREAM [CONVATEC INC]	3
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	SENSI CARE CLEAR ZINC (DIMETHICONE, ZINC OXIDE) CREAM [CONVATEC INC]	3
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	SENSI CARE CLEAR ZINC (DIMETHICONE, ZINC OXIDE) CREAM [CONVATEC INC]	3
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	SENSI CARE CLEAR ZINC (DIMETHICONE, ZINC OXIDE) CREAM [CONVATEC INC]	3
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	SENSI CARE CLEAR ZINC (DIMETHICONE, ZINC OXIDE) CREAM [CONVATEC INC]	3
CARTHAMUS TINCTORIUS SEED OLEOSOMES	INACTIVE INGREDIENT	9S60Q72309	SENSI CARE CLEAR ZINC (DIMETHICONE, ZINC OXIDE) CREAM [CONVATEC INC]	3
COCOA BUTTER	INACTIVE INGREDIENT	512OYT1CRR	SENSI CARE CLEAR ZINC (DIMETHICONE, ZINC OXIDE) CREAM [CONVATEC INC]	3
COCONUT OIL	INACTIVE INGREDIENT	Q9L0O73W7L	SENSI CARE CLEAR ZINC (DIMETHICONE, ZINC OXIDE) CREAM [CONVATEC INC]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SENSI CARE CLEAR ZINC (DIMETHICONE, ZINC OXIDE) CREAM [CONVATEC INC]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	SENSI CARE CLEAR ZINC (DIMETHICONE, ZINC OXIDE) CREAM [CONVATEC INC]	3
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	SENSI CARE CLEAR ZINC (DIMETHICONE, ZINC OXIDE) CREAM [CONVATEC INC]	3
JOJOBA OIL	INACTIVE INGREDIENT	724GKU717M	SENSI CARE CLEAR ZINC (DIMETHICONE, ZINC OXIDE) CREAM [CONVATEC INC]	3
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	SENSI CARE CLEAR ZINC (DIMETHICONE, ZINC OXIDE) CREAM [CONVATEC INC]	3
LEVANT COTTONSEED OIL	INACTIVE INGREDIENT	N5CFT140R8	SENSI CARE CLEAR ZINC (DIMETHICONE, ZINC OXIDE) CREAM [CONVATEC INC]	3
MICROCRYSTALLINE WAX	INACTIVE INGREDIENT	XOF597Q3KY	SENSI CARE CLEAR ZINC (DIMETHICONE, ZINC OXIDE) CREAM [CONVATEC INC]	3
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	SENSI CARE CLEAR ZINC (DIMETHICONE, ZINC OXIDE) CREAM [CONVATEC INC]	3
OLEIC ACID	INACTIVE INGREDIENT	2UMI9U37CP	SENSI CARE CLEAR ZINC (DIMETHICONE, ZINC OXIDE) CREAM [CONVATEC INC]	3
PECTIN	INACTIVE INGREDIENT	89NA02M4RX	SENSI CARE CLEAR ZINC (DIMETHICONE, ZINC OXIDE) CREAM [CONVATEC INC]	3
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	SENSI CARE CLEAR ZINC (DIMETHICONE, ZINC OXIDE) CREAM [CONVATEC INC]	3
PUNICA GRANATUM WHOLE	INACTIVE INGREDIENT	O2ZTS50U5E	SENSI CARE CLEAR ZINC (DIMETHICONE, ZINC OXIDE) CREAM [CONVATEC INC]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SENSI CARE CLEAR ZINC (DIMETHICONE, ZINC OXIDE) CREAM [CONVATEC INC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	SENSI CARE CLEAR ZINC (DIMETHICONE, ZINC OXIDE) CREAM [CONVATEC INC]	3

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
92RU3N3Y1O	DIMETHICONE	9006-65-9	DIMETHICONE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43553-0007-2	43553000702	56 g in 1 TUBE (43553-0007-2)	56 g	2014-06-12	2021-10-14	No	No	Current
43553-0007-5	43553000705	141 g in 1 TUBE (43553-0007-5)	141 g	2014-06-12	2021-10-14	No	No	Current