FDA.reportPublic FDA data

VCF CONTRACEPTIVE PRE-FILLED APPLICATORS

Product NDC
52925-512
11-digit product format
529250512
Labeler code
52925
Product ID
52925-512_de962fbf-0693-4095-90ae-bd32e9835461
Type
HUMAN OTC DRUG
Nonproprietary name
NONOXYNOL-9
Dosage form
GEL, METERED
Route
VAGINAL
Labeler
APOTHECUS PHARMACEUTICAL CORP
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-06-01
Substance
NONOXYNOL-9
Active strength
4 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VCF CONTRACEPTIVE PRE-FILLED APPLICATORS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NONOXYNOL-94 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii48Q180SH9T
Rxcui198765, 1597814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52925-512-102025-12-12C16284748780-13b156c62-25fd-fb37-e063-e6dba90a4e07VCF ® CONTRACEPTIVE GEL PRE-FILLED APPLICATORS
52925-512-252025-12-12C16284748780-13b156c62-25fd-fb37-e063-e6dba90a4e07VCF ® CONTRACEPTIVE GEL PRE-FILLED APPLICATORS
52925-512-102025-07-29C16284748780-13b156c62-25fd-fb37-e063-e6dba90a4e07VCF ® CONTRACEPTIVE GEL PRE-FILLED APPLICATORS
52925-512-252025-07-29C16284748780-13b156c62-25fd-fb37-e063-e6dba90a4e07VCF ® CONTRACEPTIVE GEL PRE-FILLED APPLICATORS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52925-512-10VCF CONTRACEPTIVE PRE-FILLED APPLICATORS10 in 1 BOXGEL, METERED107
52925-512-10VCF CONTRACEPTIVE PRE-FILLED APPLICATORS2.55 g in 1 APPLICATORGEL, METERED2.557
52925-512-25VCF CONTRACEPTIVE PRE-FILLED APPLICATORS250 in 1 CARTONGEL, METERED2507
52925-512-25VCF CONTRACEPTIVE PRE-FILLED APPLICATORS2.55 g in 1 APPLICATORGEL, METERED2.557

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52925-512-10GM - Gram52925-51271db3b09-590d-4b23-b72a-c34638e0a90212016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NONOXYNOL-9ACTIVE INGREDIENT48Q180SH9TVCF CONTRACEPTIVE PRE-FILLED APPLICATORS (NONOXYNOL-9) GEL, METERED [APOTHECUS PHARMACEUTICAL CORP]1
NONOXYNOL-9ACTIVE MOIETY48Q180SH9TVCF CONTRACEPTIVE PRE-FILLED APPLICATORS (NONOXYNOL-9) GEL, METERED [APOTHECUS PHARMACEUTICAL CORP]1
Edetate TrisodiumINACTIVE INGREDIENT420IP921MBVCF CONTRACEPTIVE PRE-FILLED APPLICATORS (NONOXYNOL-9) GEL, METERED [APOTHECUS PHARMACEUTICAL CORP]1
Lactic AcidINACTIVE INGREDIENT33X04XA5ATVCF CONTRACEPTIVE PRE-FILLED APPLICATORS (NONOXYNOL-9) GEL, METERED [APOTHECUS PHARMACEUTICAL CORP]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TVCF CONTRACEPTIVE PRE-FILLED APPLICATORS (NONOXYNOL-9) GEL, METERED [APOTHECUS PHARMACEUTICAL CORP]1
Potassium SorbateINACTIVE INGREDIENT1VPU26JZZ4VCF CONTRACEPTIVE PRE-FILLED APPLICATORS (NONOXYNOL-9) GEL, METERED [APOTHECUS PHARMACEUTICAL CORP]1
Povidone K30INACTIVE INGREDIENTU725QWY32XVCF CONTRACEPTIVE PRE-FILLED APPLICATORS (NONOXYNOL-9) GEL, METERED [APOTHECUS PHARMACEUTICAL CORP]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3VCF CONTRACEPTIVE PRE-FILLED APPLICATORS (NONOXYNOL-9) GEL, METERED [APOTHECUS PHARMACEUTICAL CORP]1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EUVCF CONTRACEPTIVE PRE-FILLED APPLICATORS (NONOXYNOL-9) GEL, METERED [APOTHECUS PHARMACEUTICAL CORP]1
SorbitolINACTIVE INGREDIENT506T60A25RVCF CONTRACEPTIVE PRE-FILLED APPLICATORS (NONOXYNOL-9) GEL, METERED [APOTHECUS PHARMACEUTICAL CORP]1
WaterINACTIVE INGREDIENT059QF0KO0RVCF CONTRACEPTIVE PRE-FILLED APPLICATORS (NONOXYNOL-9) GEL, METERED [APOTHECUS PHARMACEUTICAL CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52925-512VCF CONTRACEPTIVE PRE-FILLED APPLICATORS (NONOXYNOL-9) GEL, METERED [APOTHECUS PHARMACEUTICAL CORP]6Current NDC, Legacy NDC, 4 package rows20241218_34be97cd-3646-427d-8112-ba0030ff8d88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198765nonoxynol-9 4 % Vaginal GelPSN34be97cd-3646-427d-8112-ba0030ff8d887
1597814VCF Vaginal Contraceptive 4 % Vaginal GelPSN34be97cd-3646-427d-8112-ba0030ff8d887
1597814nonoxynol-9 0.04 MG/MG Vaginal Gel [VCF Contraceptive]SBD34be97cd-3646-427d-8112-ba0030ff8d887
198765nonoxynol-9 0.04 MG/MG Vaginal GelSCD34be97cd-3646-427d-8112-ba0030ff8d887
198765nonoxynol-9 4 % Vaginal GelSY34be97cd-3646-427d-8112-ba0030ff8d887
1597814VCF Vaginal Contraceptive 4 % Vaginal GelSY34be97cd-3646-427d-8112-ba0030ff8d887

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52925-512-105292505121010 APPLICATOR in 1 BOX (52925-512-10) / 2.55 g in 1 APPLICATOR10 applicator2014-06-010000-00-00NoNoCurrent
52925-512-2552925051225250 APPLICATOR in 1 CARTON (52925-512-25) / 2.55 g in 1 APPLICATOR250 applicator2014-06-010000-00-00NoNoCurrent