Novana All-In-One One Step Perineal

Product NDC: 76077-500
11-digit product format: 760770500
Labeler code: 76077
Product ID: 76077-500_c0b20660-4e87-4171-9c70-b6192b224f2c
Type: HUMAN OTC DRUG
Nonproprietary name: Dimethicone
Dosage form: LOTION
Route: TOPICAL
Labeler: NOVANA MEDICAL LLC
Application: part356
Marketing category: OTC MONOGRAPH NOT 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	76077-500		I	Inactivated by FDA		2026-10-12
excluded package	package	76077-500	76077-500-08	I	Inactivated by FDA		2026-10-12

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 · 44 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	76077-500-08	`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	76077-500-08	`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	76077-500-08	`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	76077-500-08	`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	76077-500-08	`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	76077-500-08	`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	76077-500-08	`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	76077-500-08	`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	76077-500-08	`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	76077-500-08	`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	76077-500-08	`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	76077-500-08	`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	76077-500-08	`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	76077-500-08	`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	76077-500-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	76077-500-08	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	76077-500-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	76077-500-08	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	76077-500-08	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	76077-500-08	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	76077-500-08	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	76077-500-08	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
baf7f49c-75b6-496b-a00e-8e766a8e4f03	Product name	1	20210127
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76077-500-08	2019-11-13	C162847	48780-1	97449f38-cb54-f6ea-e053-dbdaa90aa703	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76077-500-08	Novana All-In-One One Step Perineal	240 mL in 1 BOTTLE, SPRAY	LOTION	240		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76077-500-08	ML - Milliliter	76077-500	220881c4-e0da-42a8-9d54-26dba6642d4b	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Dimethicone	ACTIVE INGREDIENT	92RU3N3Y1O	NOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]	3
Dimethicone	ACTIVE MOIETY	92RU3N3Y1O	NOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]	3
Allantoin	INACTIVE INGREDIENT	344S277G0Z	NOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]	3
Cetyl Alcohol	INACTIVE INGREDIENT	936JST6JCN	NOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]	3
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	NOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]	3
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	NOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]	3
Iodopropynyl Butylcarbamate	INACTIVE INGREDIENT	603P14DHEB	NOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]	3
Isopropyl Myristate	INACTIVE INGREDIENT	0RE8K4LNJS	NOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]	3
Panthenol	INACTIVE INGREDIENT	WV9CM0O67Z	NOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]	3
Phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	NOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]	3
Polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	NOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]	3
Propanediol	INACTIVE INGREDIENT	5965N8W85T	NOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]	3
Sodium Laureth Sulfate	INACTIVE INGREDIENT	BPV390UAP0	NOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]	3
Soybean Oil	INACTIVE INGREDIENT	241ATL177A	NOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]	3
Stearyl Alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	NOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]	3
Tocopherol	INACTIVE INGREDIENT	R0ZB2556P8	NOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]	3
Water	INACTIVE INGREDIENT	059QF0KO0R	NOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76077-500	NOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]	3	Legacy NDC, 1 package rows	20120411_8369a529-5e7c-45af-ab9a-362b8a16f57d.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198605	dimethicone 2 % Topical Lotion	PSN	8369a529-5e7c-45af-ab9a-362b8a16f57d	3
198605	dimethicone 20 MG/ML Topical Lotion	SCD	8369a529-5e7c-45af-ab9a-362b8a16f57d	3
198605	dimethicone 2 % Topical Lotion	SY	8369a529-5e7c-45af-ab9a-362b8a16f57d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
76077-500-08	76077050008	240 mL in 1 BOTTLE, SPRAY	240 ml	Historical