FDA.reportPublic FDA data

Defensol-ito

Product NDC
53145-333
11-digit product format
531450333
Labeler code
53145
Product ID
53145-333_3a8ae61d-30c1-903c-e063-6394a90ae5c2
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan, Guiafenesin, Phenylephrine
Dosage form
SOLUTION
Route
ORAL
Labeler
Menper Distributors, Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-01-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
4; 50; 2.5 mg/mL; mg/mL; mg/mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Defensol-ito
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE4 mg/mL
GUAIFENESIN50 mg/mL
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Rxcui1661314

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53145-333-152023-07-28C16284748780-19d75b9d0-fdb7-f424-e053-dadaa90a57ceDefensol-ito solution
53145-333-152021-08-09C16284748780-19d75b9d0-fdb7-f424-e053-dadaa90a57ceDefensol-ito solution
53145-333-152020-01-31C16284748780-19d75b9d0-fdb7-f424-e053-dadaa90a57ceDefensol-ito solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-333-15Defensol-ito30 mL in 1 BOTTLE, DROPPERSOLUTION308
53145-333-15Defensol-ito1 in 1 CARTONSOLUTION18

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]5
GUAIFENESINACTIVE INGREDIENT495W7451VQDEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]5
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]5
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]5
GUAIFENESINACTIVE MOIETY495W7451VQDEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]5
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]5
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]5
CORN SYRUPINACTIVE INGREDIENT9G5L16BK6NDEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]5
GUAR GUMINACTIVE INGREDIENTE89I1637KEDEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]5
MENTHOLINACTIVE INGREDIENTL7T10EIP3ADEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]5
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]5
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYDEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]5
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]5
WATERINACTIVE INGREDIENT059QF0KO0RDEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]5

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1661314dextromethorphan HBr 4 MG / guaiFENesin 50 MG / phenylephrine HCl 2.5 MG in 1 mL Oral SolutionPSNa7c7a60d-d49f-4239-92f7-714eac7eb0c58
1661314dextromethorphan hydrobromide 4 MG/ML / guaifenesin 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Oral SolutionSCDa7c7a60d-d49f-4239-92f7-714eac7eb0c58

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53145-333-15531450333151 BOTTLE, DROPPER in 1 CARTON (53145-333-15) / 30 mL in 1 BOTTLE, DROPPER2014-01-010000-00-00NoNoCurrent