FDA.reportPublic FDA data

NDC 34362-0302-1 - Gynol II Extra Strength

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
34362-0302
Requested NDC
34362-0302-1
Package NDCs from labels
34362-0302-1, 34362-0302-5
Manufacturer
Caldwell Consumer Health LLC | Lornamead | DPT Laboratories
Effective date
2020-12-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nonoxynol - Caldwell Consumer Health LLC | Lornamead | DPT LaboratoriesCaldwell Consumer Health LLC | Lornamead | DPT Laboratories2020-12-01HUMAN OTC DRUG LABEL

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 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 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#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NONOXYNOL-9ACTIVE INGREDIENT48Q180SH9TGYNOL II EXTRA STRENGTH (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]3
NONOXYNOL-9ACTIVE MOIETY48Q180SH9TGYNOL II EXTRA STRENGTH (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]3
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311GYNOL II EXTRA STRENGTH (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]3
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATGYNOL II EXTRA STRENGTH (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGYNOL II EXTRA STRENGTH (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]3
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQGYNOL II EXTRA STRENGTH (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GYNOL II EXTRA STRENGTH (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]3
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BGYNOL II EXTRA STRENGTH (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]3
SORBITOLINACTIVE INGREDIENT506T60A25RGYNOL II EXTRA STRENGTH (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RGYNOL II EXTRA STRENGTH (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]3

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 2 of 19 · 365 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Revitalize Energizing Eye DropsNAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOLRevitalize Energy Inc.518aac87-1642-4b2f-bca1-b74d21261eea2026-07-16WarningsExact identifier
unii: 6DC9Q167V3
Retaine CMCCARBOXYMETHYLCELLULOSE SODIUMOCuSOFT LLCa3698c71-0c80-4246-be52-5e7d96f6c5402026-07-06WarningsExact identifier
unii: K679OBS311
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
SKIN TAG REMOVERSALICYLIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.3a5e2105-7125-183c-e063-6394a90ae8792026-07-02WarningsExact identifier
unii: 33X04XA5AT
WART SKIN TAG REMOVERSALICYLIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.3a5b64a3-b19e-8b1a-e063-6294a90a66412026-07-02WarningsExact identifier
unii: 33X04XA5AT
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: 506T60A25R
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Lubricant EyeCARBOXYMETHYLCELLULOSE SODIUM 0.5%CARDINAL HEALTH 110, LLC. DBA LEADER51a2d74f-5ff3-9921-e063-6294a90a345a2026-06-15WarningsExact identifier
unii: K679OBS311
Lubricant EyeCARBOXYMETHYLCELLULOSE SODIUMRugby Laboratories51cadca6-a31b-c1b5-e063-6394a90a34d32026-06-15WarningsExact identifier
unii: K679OBS311
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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