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 71 of 178 · 3,551 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Honey Lemon cough drops MENTHOL Walmart Stores Inc. 317bbd33-6087-3af1-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Good Sense Nasal Decongestant PSEUDOEPHEDRINE HCL L. Perrigo Company 455b35b4-3969-411b-8036-887615d71e11 2025-12-21 Warnings Exact identifier application number: M012 Menthol Cough Drop MENTHOL Safeway Inc. 4a4f7f82-1b6c-7082-e054-00144ff88e88 2025-12-20 Warnings Exact identifier application number: M012 Cherry Cough Drop MENTHOL Safeway Inc. 4a52c0c2-8659-2819-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 Signature Care Cherry Cough Drops MENTHOL Safeway a733e905-af15-d3ea-e053-2a95a90aa7c3 2025-12-20 Warnings Exact identifier application number: M012 Signature Care Honey Lemon Cough Drops MENTHOL Safeway a742449f-c76b-2b91-e053-2a95a90ae4d2 2025-12-20 Warnings Exact identifier application number: M012 Cherry Sore Throat Lozenge BENZOCAINE TopCo 60b876e7-c642-5ce8-e053-2a91aa0abd6e 2025-12-20 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL Topco Associates 366cc6b1-beff-29d2-e054-00144ff88e88 2025-12-20 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL TopCo Associates 3fef2117-7311-1e66-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Topco Associates 3ff1bf05-e407-3b67-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 sugar free menthol cough drops MENTHOL Topco Associates 36727f0c-d6d2-28a3-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 sugar free honey lemon cough drops MENTHOL Topco Associates 36824bee-607e-7095-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 Mixed Berry Sore Throat Lozenges BENZOCAINE Topco Associates 7a00c771-9231-e877-e053-2a91aa0ac96e 2025-12-20 Warnings Exact identifier application number: M012 MUCUS RELIEF GUAIFENESIN 400 MG NUVICARE LLC e25b440e-f389-443f-b333-c66ad1747158 2025-12-19 Warnings Exact identifier application number: M012 Cold and Flu severe ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL Wal-Mart Stores Inc 9fca25dc-f63e-487a-8b7c-84d65ea51cb5 2025-12-19 Warnings Exact identifier application number: M012 Cold and Flu Severe ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL Geiss, Destin & Dunn Inc. a7d2eaee-484e-43aa-8ae3-0e050219383f 2025-12-19 Warnings Exact identifier application number: M012 Cherry Cough Drops MENTHOL Publix 66d8e5f7-9766-57f3-e053-2991aa0a7e17 2025-12-19 Warnings Exact identifier application number: M012 Honey Lemon Cough Drops MENTHOL Publix 66e89fa3-ee09-1d16-e053-2a91aa0ae17c 2025-12-19 Warnings Exact identifier application number: M012 Poly-Vent DM DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL Poly Pharmaceuticals, Inc. 739329ae-0b62-4eab-a07d-867b5d3d61e0 2025-12-19 Warnings Exact identifier application number: M012 Chest Congestion and Cough Relief DM DEXTROMETHORPHAN HBR, GUAIFENESIN ARMY AND AIR FORCE EXCHANGE SERVICE 89494a7c-cdbf-48f1-aaa9-2e57d4388a68 2025-12-19 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