Novana Moisturizing

Product NDC: 76077-200
11-digit product format: 760770200
Labeler code: 76077
Product ID: 76077-200_041a4d30-30e6-4049-b74e-32e7a6529250
Type: HUMAN OTC DRUG
Nonproprietary name: Dimethicone
Dosage form: CREAM
Route: TOPICAL
Labeler: NOVANA MEDICAL LLC
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-04-04
Marketing end: 0000-00-00
Substance: DIMETHICONE
Active strength: 0 mL/mL
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	76077-200		I	Inactivated by FDA	2026-10-05
excluded package	package	76077-200	76077-200-04	I	Inactivated by FDA	2026-10-05
excluded package	package	76077-200	76077-200-07	I	Inactivated by FDA	2026-10-05
excluded package	package	76077-200	76077-200-09	I	Inactivated by FDA	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 2 · 88 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	76077-200-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76077-200-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76077-200-04	`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	76077-200-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76077-200-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76077-200-04	`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	76077-200-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76077-200-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76077-200-04	`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	76077-200-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76077-200-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76077-200-04	`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	76077-200-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76077-200-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76077-200-04	`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	76077-200-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76077-200-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76077-200-04	`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	76077-200-09	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76077-200-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76077-200-04	`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	76077-200-09	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76077-200-07	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76077-200-04	`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	76077-200-09	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76077-200-07	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76077-200-04	`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	76077-200-09	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	76077-200-07	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	76077-200-04	`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	76077-200-09	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	76077-200-07	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	76077-200-04	`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	76077-200-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	76077-200-07	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	76077-200-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	76077-200-09	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	76077-200-07	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	76077-200-04	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	76077-200-09	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	76077-200-07	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	76077-200-04	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	76077-200-09	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	76077-200-07	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	76077-200-04	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76077-200-04	2019-11-13	C162847	48780-1	97449f38-d1ae-f6ea-e053-dbdaa90aa703	Drug Facts
76077-200-07	2019-11-13	C162847	48780-1	97449f38-d1ae-f6ea-e053-dbdaa90aa703	Drug Facts
76077-200-09	2019-11-13	C162847	48780-1	97449f38-d1ae-f6ea-e053-dbdaa90aa703	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76077-200-04	Novana Moisturizing	120 mL in 1 TUBE	CREAM	120	3
76077-200-07	Novana Moisturizing	210 mL in 1 TUBE	CREAM	210	3
76077-200-09	Novana Moisturizing	270 mL in 1 TUBE	CREAM	270	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76077-200-04	GM - Gram	76077-200	8b79f35e-16b3-4bce-9406-f58fad373fa8	1	2013-02-13
76077-200-07	GM - Gram	76077-200	79f75801-d919-42ec-b17d-26f427fe3571	1	2013-02-13
76077-200-09	GM - Gram	76077-200	13ae9b41-bca3-4a3f-a525-f1c5c9f46862	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Dimethicone	ACTIVE INGREDIENT	92RU3N3Y1O	NOVANA MOISTURIZING (DIMETHICONE) CREAM [NOVANA MEDICAL LLC]	3
Dimethicone	ACTIVE MOIETY	92RU3N3Y1O	NOVANA MOISTURIZING (DIMETHICONE) CREAM [NOVANA MEDICAL LLC]	3
Cetyl Alcohol	INACTIVE INGREDIENT	936JST6JCN	NOVANA MOISTURIZING (DIMETHICONE) CREAM [NOVANA MEDICAL LLC]	3
Cod Liver Oil	INACTIVE INGREDIENT	BBL281NWFG	NOVANA MOISTURIZING (DIMETHICONE) CREAM [NOVANA MEDICAL LLC]	3
Diazolidinyl Urea	INACTIVE INGREDIENT	H5RIZ3MPW4	NOVANA MOISTURIZING (DIMETHICONE) CREAM [NOVANA MEDICAL LLC]	3
Glyceryl Monostearate	INACTIVE INGREDIENT	230OU9XXE4	NOVANA MOISTURIZING (DIMETHICONE) CREAM [NOVANA MEDICAL LLC]	3
HIGH DENSITY POLYETHYLENE	INACTIVE INGREDIENT	UG00KM4WR7	NOVANA MOISTURIZING (DIMETHICONE) CREAM [NOVANA MEDICAL LLC]	3
Lanolin	INACTIVE INGREDIENT	7EV65EAW6H	NOVANA MOISTURIZING (DIMETHICONE) CREAM [NOVANA MEDICAL LLC]	3
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	NOVANA MOISTURIZING (DIMETHICONE) CREAM [NOVANA MEDICAL LLC]	3
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	NOVANA MOISTURIZING (DIMETHICONE) CREAM [NOVANA MEDICAL LLC]	3
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	NOVANA MOISTURIZING (DIMETHICONE) CREAM [NOVANA MEDICAL LLC]	3
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	NOVANA MOISTURIZING (DIMETHICONE) CREAM [NOVANA MEDICAL LLC]	3
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)	INACTIVE INGREDIENT	1DXE3F3OZX	NOVANA MOISTURIZING (DIMETHICONE) CREAM [NOVANA MEDICAL LLC]	3
Sodium Laureth Sulfate	INACTIVE INGREDIENT	BPV390UAP0	NOVANA MOISTURIZING (DIMETHICONE) CREAM [NOVANA MEDICAL LLC]	3
SODIUM POLYACRYLATE (2500000 MW)	INACTIVE INGREDIENT	05I15JNI2J	NOVANA MOISTURIZING (DIMETHICONE) CREAM [NOVANA MEDICAL LLC]	3
Water	INACTIVE INGREDIENT	059QF0KO0R	NOVANA MOISTURIZING (DIMETHICONE) CREAM [NOVANA MEDICAL LLC]	3
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	NOVANA MOISTURIZING (DIMETHICONE) CREAM [NOVANA MEDICAL LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76077-200	NOVANA MOISTURIZING (DIMETHICONE) CREAM [NOVANA MEDICAL LLC]	3	Legacy NDC, 3 package rows	20120417_b93a9119-e910-4c5e-ba4d-cbdd11b1f32d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
92RU3N3Y1O	DIMETHICONE	9006-65-9	DIMETHICONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
76077-200-04	76077020004	120 mL in 1 TUBE	120 ml	Historical
76077-200-07	76077020007	210 mL in 1 TUBE	210 ml	Historical
76077-200-09	76077020009	270 mL in 1 TUBE	270 ml	Historical