FDA.reportPublic FDA data

Conceptrol

Product NDC
34362-0300
11-digit product format
343620300
Labeler code
34362
Product ID
34362-0300_9a4c2790-9192-4949-8529-c1b19a8a3f66
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
4 g/100g
NDC exclude flag
No
Listing certified through
2019-12-31
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
34362-0300-52020-01-31C16284748780-19d75b9d0-e125-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34362-0300-1ConceptrolOptions2.55 g in 1 APPLICATORGEL2.552
34362-0300-5ConceptrolOptions10 in 1 CARTONGEL102

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NONOXYNOL-9ACTIVE INGREDIENT48Q180SH9TCONCEPTROL OPTIONS (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]2
NONOXYNOL-9ACTIVE MOIETY48Q180SH9TCONCEPTROL OPTIONS (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311CONCEPTROL OPTIONS (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]2
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATCONCEPTROL OPTIONS (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCONCEPTROL OPTIONS (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]2
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQCONCEPTROL OPTIONS (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CONCEPTROL OPTIONS (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]2
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BCONCEPTROL OPTIONS (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]2
SORBITOLINACTIVE INGREDIENT506T60A25RCONCEPTROL OPTIONS (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RCONCEPTROL OPTIONS (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34362-0300CONCEPTROL OPTIONS (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]2Legacy NDC, 2 package rows20131219_5e3d5d8b-b692-4d84-a543-52a2eedbfcf2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
845305CONCEPTROL 4 % Vaginal GelPSN5e3d5d8b-b692-4d84-a543-52a2eedbfcf22
198765nonoxynol-9 4 % Vaginal GelPSN5e3d5d8b-b692-4d84-a543-52a2eedbfcf22
845305nonoxynol-9 0.04 MG/MG Vaginal Gel [Conceptrol]SBD5e3d5d8b-b692-4d84-a543-52a2eedbfcf22
198765nonoxynol-9 0.04 MG/MG Vaginal GelSCD5e3d5d8b-b692-4d84-a543-52a2eedbfcf22
845305Conceptrol 4 % Vaginal GelSY5e3d5d8b-b692-4d84-a543-52a2eedbfcf22
845305Conceptrol Options 4 % Vaginal GelSY5e3d5d8b-b692-4d84-a543-52a2eedbfcf22
198765nonoxynol-9 4 % Vaginal GelSY5e3d5d8b-b692-4d84-a543-52a2eedbfcf22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
34362-0300-1343620300012.55 g in 1 APPLICATOR2.55 gHistorical
34362-0300-53436203000510 in 1 CARTONHistorical