VANOXIDE

Product NDC: 11086-032
11-digit product format: 110860032
Labeler code: 11086
Product ID: 11086-032_f214686c-60e8-4aee-e053-2a95a90a9836
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BENZOYL PEROXIDE, HYDROCORTISONE
Dosage form: LOTION
Route: TOPICAL
Labeler: Summers Laboratories Inc
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2009-11-01
Marketing end: 0000-00-00
Substance: BENZOYL PEROXIDE; HYDROCORTISONE
Active strength: 5 g/100g; g/100g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2024-12-31
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	11086-032		I	Inactivated by FDA		2026-10-15
excluded package	package	11086-032	11086-032-01	I	Inactivated by FDA		2026-10-15

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	11086-032-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	11086-032-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	11086-032-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	11086-032-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	11086-032-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	11086-032-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	11086-032-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	11086-032-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	11086-032-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
15bd4439-874a-4934-9954-248e5455d460	Product name	1	20260310
9962b773-9f2e-22cc-0032-535e48ac417b	Product name	3	20250724
a46239a7-5963-4008-8cbb-6b9000f497eb	Product name	1	20250721
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2	Product name	1	20250325
b382b4e1-6b48-45f6-bffc-e61b00b0ce19	Product name	3	20250317
d9d61457-6a5a-41fc-b418-e5479a2904b7	Product name	2	20230303
32012d5c-25ac-49c7-9d4c-1313177fff7c	Product name	1	20230112
4d56e8eb-d741-d4a5-de3f-2bab1af75a60	Product name	7	20220608
13e7e7e3-e885-4c79-af6d-dad1aedbb06e	Product name	1	20220128
4a7d44fe-774d-404b-aad0-8a90fe78375a	Product name	4	20211025
626d7260-31b5-4412-84fd-579746adb6b3	Product name	1	20210513
3f45980c-c196-47e5-0e5e-48b7c57327c5	Product name	5	20200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27b	Product name	3	20200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992	Product name	4	20190619
8a011600-5e61-4c59-ab7b-54ab658a3b71	Product name	2	20181127
a919621a-248d-3c7a-1084-9f9ce286fdfd	Product name	2	20181009
e7d5a174-836b-a0af-b014-cb0826c69ddc	Product name	2	20181004
fcce390d-6460-4701-87cf-940d8800a1c3	Product name	2	20180212
ad75fcfd-a339-42a1-9c60-43ba2c654cfa	Product name	1	20170810
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1	Product name	2	20150218
02657a3f-1489-66ea-f740-5ab9524e57d7	Product name	1	20140508
26f3d783-2cc1-4327-e77d-71804cf675a2	Product name	1	20140508
36fdc54c-bbeb-981e-8a53-4d768e283892	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
61e59a42-186b-9f4b-aec3-fb49a6debc31	Product name	1	20140508
705740e1-dee5-2610-c5a3-4c59cd9d62af	Product name	1	20140508
7bdc4804-3832-c0df-e519-72b6d47c9792	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
abaf203f-619e-f265-559f-8c81af5cb1c2	Product name	1	20140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fd	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508
fe21f3fd-a378-0654-1972-db3c3b64470e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
11086-032-01	2025-01-30	C162847	48780-1	2cef2736-69dd-d83d-e063-dadaa90ab31f	SUMMERS LABS (as PLD) - VANOXIDE (11086-032)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11086-032-01	VANOXIDEHC	25 g in 1 BOTTLE	LOTION	25		23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11086-032-01	GM - Gram	11086-032	033a331d-4f31-46a1-a631-fa1b379fd454	1	2013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZOYL PEROXIDE	ACTIVE INGREDIENT	W9WZN9A0GM	VANOXIDE HC (BENZOYL PEROXIDE, HYDROCORTISONE) LOTION [SUMMERS LABORATORIES INC]	3
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	VANOXIDE HC (BENZOYL PEROXIDE, HYDROCORTISONE) LOTION [SUMMERS LABORATORIES INC]	3
BENZOYL PEROXIDE	ACTIVE MOIETY	W9WZN9A0GM	VANOXIDE HC (BENZOYL PEROXIDE, HYDROCORTISONE) LOTION [SUMMERS LABORATORIES INC]	3
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	VANOXIDE HC (BENZOYL PEROXIDE, HYDROCORTISONE) LOTION [SUMMERS LABORATORIES INC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11086-032	VANOXIDE HC (BENZOYL PEROXIDE, HYDROCORTISONE) LOTION [SUMMERS LABORATORIES INC]	23	Legacy NDC, 1 package rows	20231010_1f0edbd9-103e-4a49-b7a8-6552ef172c13.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W9WZN9A0GM	BENZOYL PEROXIDE	94-36-0	BENZOYL PEROXIDE
WI4X0X7BPJ	HYDROCORTISONE	50-23-7	HYDROCORTISONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
244382	benzoyl peroxide 5 % / hydrocortisone 0.5 % Topical Lotion	PSN	1f0edbd9-103e-4a49-b7a8-6552ef172c13	23
211765	Vanoxide-HC (benzoyl peroxide 5 % / hydrocortisone 0.5 % ) Topical Lotion	PSN	1f0edbd9-103e-4a49-b7a8-6552ef172c13	23
211765	benzoyl peroxide 50 MG/ML / hydrocortisone 5 MG/ML Topical Lotion [Vanoxide-HC]	SBD	1f0edbd9-103e-4a49-b7a8-6552ef172c13	23
244382	benzoyl peroxide 50 MG/ML / hydrocortisone 5 MG/ML Topical Lotion	SCD	1f0edbd9-103e-4a49-b7a8-6552ef172c13	23
244382	benzoyl peroxide 5 % / hydrocortisone 0.5 % Topical Lotion	SY	1f0edbd9-103e-4a49-b7a8-6552ef172c13	23
211765	Vanoxide-HC (benzoyl peroxide 5 % / hydrocortisone 0.5 % ) Topical Lotion	SY	1f0edbd9-103e-4a49-b7a8-6552ef172c13	23

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11086-032-01	11086003201	25 g in 1 BOTTLE (11086-032-01)	25 g	2009-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SUMMERS LABS (as PLD) - VANOXIDE (11086-032)	Summers Laboratories Inc	2023-10-09	HUMAN PRESCRIPTION DRUG LABEL	23