Gynol II

Product NDC
34362-0302
11-digit product format
343620302
Labeler code
34362
Product ID
34362-0302_3cadc6ea-8dc2-4fa2-8fdf-aebfe1378941
Type
HUMAN OTC DRUG
Nonproprietary name
Nonoxynol
Dosage form
GEL
Route
VAGINAL
Labeler
Caldwell Consumer Health LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-05-01
Marketing end
0000-00-00
Substance
NONOXYNOL-9
Active strength
3 g/100g
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
34362-0302-52022-01-28C16284748780-19d75b9d0-30a9-f424-e053-dadaa90a57ceDrug Facts
34362-0302-52020-12-01C16284748780-19d75b9d0-30a9-f424-e053-dadaa90a57ceDrug Facts
34362-0302-52020-01-31C16284748780-19d75b9d0-30a9-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34362-0302-1Gynol IIExtra Strength81 g in 1 BOTTLE, WITH APPLICATORGEL817
34362-0302-5Gynol IIExtra Strength1 in 1 CARTONGEL17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
34362-0302-1GM - Gram34362-030267da3f90-9ddf-4646-807a-abbb4d77ffef12018-03-08

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34362-0302GYNOL II EXTRA STRENGTH (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]7Legacy NDC, 2 package rows20201203_eaf86a36-0573-4c39-9324-88919c4d009b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250090GYNOL II Extra Strength 3 % Vaginal GelPSNeaf86a36-0573-4c39-9324-88919c4d009b7
312029nonoxynol-9 3 % Vaginal GelPSNeaf86a36-0573-4c39-9324-88919c4d009b7
1250090nonoxynol-9 0.03 MG/MG Vaginal Gel [Gynol II]SBDeaf86a36-0573-4c39-9324-88919c4d009b7
312029nonoxynol-9 0.03 MG/MG Vaginal GelSCDeaf86a36-0573-4c39-9324-88919c4d009b7
1250090Gynol II 0.03 MG/MG Vaginal GelSYeaf86a36-0573-4c39-9324-88919c4d009b7
1250090Gynol II Extra Strength 3 % Vaginal GelSYeaf86a36-0573-4c39-9324-88919c4d009b7
312029nonoxynol-9 3 % Vaginal GelSYeaf86a36-0573-4c39-9324-88919c4d009b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
34362-0302-13436203020181 g in 1 BOTTLE, WITH APPLICATOR81 gHistorical
34362-0302-5343620302051 BOTTLE, WITH APPLICATOR in 1 CARTON (34362-0302-5) > 81 g in 1 BOTTLE, WITH APPLICATOR (34362-0302-1) 2020-12-010000-00-00NoNoCurrent