FDA.reportPublic FDA data

VANOXIDE

Manufacturer
Summers Laboratories Inc
Effective date
2023-10-09
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
23
Source
full-release
Hydrated at
2026-05-31 20:53:47

Label at a glance#

ProductVANOXIDE HC
Active ingredientBENZOYL PEROXIDE, HYDROCORTISONE
Label structure6 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS:

BENZOYL PEROXIDE 5%

HYDROCORTISONE 0.5%

WARNINGS SECTION

Apply with caution on neck and/or other sensitive areas. There may be a slight transitory stinging or burning sensation on initial applications. Colored or dyed garments and linens may be bleached by the action of benzoyl peroxide. If irritation or sensitivity is
observed, discontinue use and consult your physician.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

DOSAGE & ADMINISTRATION SECTION

TO THE PHARMACIST:
Prior to dispensing, add powder content of vial* to lotion. Shake bottle thoroughly to disperse completely. After addition of powder, place expiration date of 3 months on the bottle.
*Benzoyl-Pak™

INDICATIONS & USAGE SECTION

  • Keep away from eyes. FOR TOPICAL USE ONLY.Not for ophthalmic, oral or intravaginal use.
  • Shake well before using.
  • Keep tightly closed.
  • Store at room temperature. 20°-25° C (68°-77° F). Do not freeze.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VHC-25G-cartonVHC-25G-carton

VHC-25G-labelVHC-25G-label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
244382benzoyl peroxide 5 % / hydrocortisone 0.5 % Topical LotionPSN23
211765Vanoxide-HC (benzoyl peroxide 5 % / hydrocortisone 0.5 % ) Topical LotionPSN23
211765benzoyl peroxide 50 MG/ML / hydrocortisone 5 MG/ML Topical Lotion [Vanoxide-HC]SBD23
244382benzoyl peroxide 50 MG/ML / hydrocortisone 5 MG/ML Topical LotionSCD23
244382benzoyl peroxide 5 % / hydrocortisone 0.5 % Topical LotionSY23
211765Vanoxide-HC (benzoyl peroxide 5 % / hydrocortisone 0.5 % ) Topical LotionSY23

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROCORTISONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11086-032-012025-01-30C16284748780-12cef2736-69dd-d83d-e063-dadaa90ab31fSUMMERS LABS (as PLD) - VANOXIDE (11086-032)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11086-032-01VANOXIDEHC25 g in 1 BOTTLELOTION2523

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11086-032VANOXIDE HC (BENZOYL PEROXIDE, HYDROCORTISONE) LOTION [SUMMERS LABORATORIES INC]23Legacy NDC, 1 package rows20231010_1f0edbd9-103e-4a49-b7a8-6552ef172c13.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11086-032-01GM - Gram11086-032033a331d-4f31-46a1-a631-fa1b379fd45412013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GM3
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJ3
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GM3
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJ3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11086-03211086-032-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOYL PEROXIDEW9WZN9A0GMACTIB
HYDROCORTISONEWI4X0X7BPJACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
074cfc73-ce31-5fe4-e063-6394a90a307a1f0edbd9-103e-4a49-b7a8-6552ef172c132023-10-09WarningsExact identifier
spl id: 074cfc73-ce31-5fe4-e063-6394a90a307a
spl set id: 1f0edbd9-103e-4a49-b7a8-6552ef172c13

Reported adverse events (FAERS/openFDA)#

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