Home NDC 53145-333 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 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53145-333-15 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53145-333-15 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53145-333-15 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Defensol-ito
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 4 mg/mL GUAIFENESIN 50 mg/mL PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 495W7451VQ Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1661314 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53145-333-15 Defensol-ito 30 mL in 1 BOTTLE, DROPPER SOLUTION 30 8 53145-333-15 Defensol-ito 1 in 1 CARTON SOLUTION 1 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC] 5 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC] 5 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC] 5 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC] 5 GUAIFENESIN ACTIVE MOIETY 495W7451VQ DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC] 5 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC] 5 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC] 5 CORN SYRUP INACTIVE INGREDIENT 9G5L16BK6N DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC] 5 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC] 5 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC] 5 GUAR GUM INACTIVE INGREDIENT E89I1637KE DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC] 5 MENTHOL INACTIVE INGREDIENT L7T10EIP3A DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC] 5 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC] 5 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC] 5 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC] 5 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC] 5 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC] 5 WATER INACTIVE INGREDIENT 059QF0KO0R DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC] 5
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 131 of 178 · 3,550 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DUAL ACTION GLACIER MINT COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. db2ab9be-507d-4768-9d00-188f751b7726 2024-12-10 Warnings Exact identifier application number: M012 Adult Allergy Relief CALMCO ALLERGY RELIEF CalmCo 08288825-0f38-b6a3-e063-6394a90aa358 2024-12-07 Warnings Exact identifier application number: M012 Original Herb Cough Drops MENTHOL Ricola Ag c142663f-086e-4ab7-a758-9107d7077537 2024-12-05 Warnings Exact identifier application number: M012 DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola Ag 984c9793-163c-4b97-b244-9b471966a122 2024-12-05 Warnings Exact identifier application number: M012 BENZEDREX PROPYLHEXEDRINE BF ASCHER AND CO INC 00d8c237-3eee-1d9f-e063-6394a90aeb86 2024-12-05 Warnings Exact identifier application number: M012 Cold Multi Symptom Daytime Nighttime ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE Chain Drug Marketing Association d5cbb5b0-564c-429e-b680-fa683e796393 2024-12-05 Warnings Exact identifier application number: M012 Cold Relief Multi-Symptom ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE TopCare de8a623f-7b10-4d56-a74b-3737e7716ffe 2024-12-05 Warnings Exact identifier application number: M012 Cold Max Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE TopCo Associates LLC 9773958b-c5e5-4da7-a8e9-6b6c223a2b30 2024-12-05 Warnings Exact identifier application number: M012 Cold Plus Head Congestion Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE TopCo Associates LLC 399e0e51-c2a7-451c-b74d-d3db140cef69 2024-12-05 Warnings Exact identifier application number: M012 Head Congestion Plus Mucus PE ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE United Natural Foods, Inc. dba UNFI 09531edc-8dbd-451f-ae02-f922e9e8c248 2024-12-05 Warnings Exact identifier application number: M012 DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola Ag 71ca8af7-172d-40da-be1e-ff3ab5568e74 2024-12-05 Warnings Exact identifier application number: M012 SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS MENTHOL Ricola Ag b790a91c-33be-4bc3-bdeb-eae6f366f085 2024-12-05 Warnings Exact identifier application number: M012 EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT MENTHOL Ricola Ag ea42e516-2ef8-41c9-ae4e-571f0147bc6b 2024-12-05 Warnings Exact identifier application number: M012 RICOLA MAX THROAT CARE SWISS CHERRY MENTHOL Ricola Ag 8b2d5c0f-509e-447d-b071-d73c4785f120 2024-12-05 Warnings Exact identifier application number: M012 SUGAR FREE GREEN TEA WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS MENTHOL Ricola Ag 8ae0e21a-44a0-4a2c-9880-54eeeaea07ea 2024-12-05 Warnings Exact identifier application number: M012 MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola Ag 6d82469b-d51c-4824-9830-6c1874ad4fe4 2024-12-05 Warnings Exact identifier application number: M012 RICOLA MAX THROAT CARE COOL PEPPERMINT MENTHOL Ricola Ag e8bedf6f-4a2e-4a76-ba8c-bdb249fb6ce5 2024-12-05 Warnings Exact identifier application number: M012 DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola Ag a535717d-ba55-45e9-9fc3-711b5d7dbf57 2024-12-05 Warnings Exact identifier application number: M012 THE ORIGINAL NATURAL HERB COUGH DROPS MENTHOL Ricola Ag 4330ee8d-0b37-4a93-886b-5fc6e6598da7 2024-12-05 Warnings Exact identifier application number: M012 COLD AND FLU DAYTIME SEVERE ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL TARGET CORP 9de99931-31ef-79e2-e053-2a95a90a98ad 2024-12-04 Warnings Exact identifier application number: M012
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 53145-333-15 53145033315 1 BOTTLE, DROPPER in 1 CARTON (53145-333-15) / 30 mL in 1 BOTTLE, DROPPER 2014-01-01 0000-00-00 No No Current