FDA.reportPublic FDA data

VCF CONTRACEPTIVE

Manufacturer
APOTHECUS PHARMACEUTICAL CORP.
Effective date
2025-12-12
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:22:50

Label at a glance#

ProductVCF CONTRACEPTIVE
Active ingredientNONOXYNOL-9
Label structure11 sections

Dosage and administration

before using this product, read the enclosed package insert for complete directions and information be sure your fingers are dry before touching the film insert one film and place as far into the vagina as possible against the cervix insert VCF ® not less than 15 minutes and not more than 3 hours before intercourse use one film before each act of intercourse

Storage and handling

When used correctly every time you have sex, latex condoms greatly reduce, but do not eliminate, the risk of catching or spreading HIV, the virus that causes AIDS. Use a latex condom without nonoxynol-9 if you or your sex partner has HIV/AIDS, multiple sex partners, or other HIV risk factors. VCF ® is tested by independent laboratories for determination of sperm inactivating qualities, using the I.P.P.F. agreed pr...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each film)

OTC - ACTIVE INGREDIENT SECTION

Nonoxynol-9, 28%

Purpose

OTC - PURPOSE SECTION

Vaginal contraceptive

Use

INDICATIONS & USAGE SECTION

for the prevention of pregnancy

Warnings

WARNINGS SECTION

  • For Vaginal Use Only
  • Not for rectal (anal) use

Sexually transmitted disease (STDs) alert

SPL UNCLASSIFIED SECTION

This product does not protect against HIV/AIDS or other STDs and may increase the risk of getting HIV from an infected partner.

OTC - DO NOT USE SECTION

Do not use if you or your sex partner has HIV/AIDS. If you do not know if you or your sex partner is infected, choose another form of birth control

When using this product

OTC - WHEN USING SECTION

  • you may get vaginal irritation (burning, itching or a rash)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you or your partner get burning, itching, a rash, or other irritation of the vagina or penis

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • before using this product, read the enclosed package insert for complete directions and information
  • be sure your fingers are dry before touching the film
  • insert one film and place as far into the vagina as possible against the cervix
  • insert VCF® not less than 15 minutes and not more than 3 hours before intercourse
  • use one film before each act of intercourse

Other information

STORAGE AND HANDLING SECTION

  • When used correctly every time you have sex, latex condoms greatly reduce, but do not eliminate, the risk of catching or spreading HIV, the virus that causes AIDS.
  • Use a latex condom without nonoxynol-9 if you or your sex partner has HIV/AIDS, multiple sex partners, or other HIV risk factors.
  • VCF® is tested by independent laboratories for determination of sperm inactivating qualities, using the I.P.P.F. agreed protocol
  • Store at 58° - 86°F (15°-30°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, polyvinyl alcohol, purified water

Questions?

OTC - QUESTIONS SECTION

1-800-879-2393 (9-5 E.S.T.)

SPL UNCLASSIFIED SECTION

Distributed By: Apothecus Pharmaceutical Corp., Oyster Bay, NY 11771

PRINCIPAL DISPLAY PANEL - 9 x 1 Film Pouch Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VCF®
Vaginal
Contraceptive
Film®
FOR PREVENTION OF PREGNANCY

  • Begins to dissolve instantly
  • Hormone free
  • Kills sperm on contact

Effective up to 3 hours!

9
SINGLE
SEALED
FILMS

Contains the Spermicide Doctors Recommend Most

Principal Display Panel - 9 x 1 Film Pouch Box
Principal Display Panel - 9 x 1 Film Pouch Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1788958nonoxynol-9 28 % Vaginal FilmPSN6
1788961VCF Contraceptive 28 % Vaginal FilmPSN6
1788961nonoxynol-9 280 MG Vaginal Film [VCF Contraceptive]SBD6
1788958nonoxynol-9 280 MG Vaginal FilmSCD6
1788958nonoxynol-9 28 % Vaginal FilmSY6
1788961VCF Contraceptive 28 % Vaginal FilmSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52925-112-012025-12-12C16284748780-13b156c62-28f4-fb37-e063-e6dba90a4e07VCF ® VAGINAL CONTRACEPTIVE FILM ®
52925-112-252025-12-12C16284748780-13b156c62-28f4-fb37-e063-e6dba90a4e07VCF ® VAGINAL CONTRACEPTIVE FILM ®
52925-112-012025-07-29C16284748780-13b156c62-28f4-fb37-e063-e6dba90a4e07VCF ® VAGINAL CONTRACEPTIVE FILM ®
52925-112-252025-07-29C16284748780-13b156c62-28f4-fb37-e063-e6dba90a4e07VCF ® VAGINAL CONTRACEPTIVE FILM ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52925-112-01VCF CONTRACEPTIVE1 in 1 POUCHFILM, SOLUBLE16
52925-112-01VCF CONTRACEPTIVE9 in 1 BOXFILM, SOLUBLE96
52925-112-25VCF CONTRACEPTIVE12 in 1 BOXFILM, SOLUBLE126
52925-112-25VCF CONTRACEPTIVE1 in 1 POUCHFILM, SOLUBLE16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52925-112-01EA - Each52925-112b1d5e50d-5c1b-4b47-ac8d-d541a46387ce12015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
NONOXYNOL-9ACTIVE INGREDIENT48Q180SH9T1
NONOXYNOL-9ACTIVE MOIETY48Q180SH9T1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J9901
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52925-11252925-112-01, 52925-112-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
NONOXYNOL-948Q180SH9TACTIB
GLYCERINPDC6A3C0OXIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii+route
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii+route
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii+route
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii+route
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii+route
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii+route
12 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990CREAM / VAGINAL0.5 %w/wExact identifier — unii+route
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii+route
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii+route
12 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990CREAM / VAGINAL0.5 %w/wExact identifier — unii+route
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii+route
12 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990CREAM / VAGINAL0.5 %w/wExact identifier — unii+route
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii+route
12 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990AEROSOL, FOAM / VAGINAL0.5 %w/wExact identifier — unii+route
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii+route
12 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990AEROSOL, FOAM / VAGINAL0.5 %w/wExact identifier — unii+route
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii+route
12 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990AEROSOL, FOAM / VAGINAL0.5 %w/wExact identifier — unii+route
6 equally ranked IID candidates

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
VCF CONTRACEPTIVENONOXYNOL-9APOTHECUS PHARMACEUTICAL CORP.92f8eee8-2456-4baf-a85e-1335c80d7fcd2025-12-12WarningsExact identifier
ndc (package): 52925-112-25
ndc (package): 52925-112-01
ndc (product): 52925-112
ndc11 (package): 52925011225
ndc11 (package): 52925011201
spl id: b8cd7899-57b0-4cae-bbfa-b245a202523d
spl set id: 92f8eee8-2456-4baf-a85e-1335c80d7fcd

Reported adverse events (FAERS/openFDA)#

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