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
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.
| 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
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 4 mg/mL |
| GUAIFENESIN | 50 mg/mL |
| PHENYLEPHRINE HYDROCHLORIDE | 2.5 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9D2RTI9KYH | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1661314 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a7c7a60d-d49f-4239-92f7-714eac7eb0c5 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53145-333-15 | 2023-07-28 | C162847 | 48780-1 | 9d75b9d0-fdb7-f424-e053-dadaa90a57ce | Defensol-ito solution |
| 53145-333-15 | 2021-08-09 | C162847 | 48780-1 | 9d75b9d0-fdb7-f424-e053-dadaa90a57ce | Defensol-ito solution |
| 53145-333-15 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-fdb7-f424-e053-dadaa90a57ce | Defensol-ito solution |
DailyMed Package Descriptions#
| 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#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| good sense allergy | DIPHENHYDRAMINE HCL | L. Perrigo Company | bf5039a0-2109-41a2-84a9-b5167d0a93da | 2026-07-22 | Warnings | M012 |
| Congestion and Headache | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | 432c3ec4-7595-4213-94e3-ce41af91804e | 2026-07-21 | Warnings | M012 |
| SKAPEMED ORIGINAL NASAL | NAPHAZOLINE HCL 0.05% ORIGINAL NASAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a208a1f-f6e8-0b4a-e063-6294a90a10c8 | 2026-07-21 | Warnings | M012 |
| SERYNTH FAST RELIEF NASAL | NAPHAZOLINE HCL 0.05% FAST RELIEF NASAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a4abdc0-aded-1b8a-e063-6394a90a9b56 | 2026-07-21 | Warnings | M012 |
| DERMFREE ORIGINAL NASAL | NAPHAZOLINE HCL0.05%ORIGINAL NASAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a4d0c03-7d8f-76cb-e063-6394a90a938c | 2026-07-21 | Warnings | M012 |
| DERMFREE ORIGINAL NASAL | NAPHAZOLINE HCL 0.05%ORIGINAL NASAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a4d3a2b-a4ed-c736-e063-6394a90a96df | 2026-07-21 | Warnings | M012 |
| Severe Cough and Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | 791eaac1-ddb5-40e2-9040-52dfadc30e06 | 2026-07-21 | Warnings | M012 |
| DRx Choice DAYTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Raritan Pharmaceuticals Inc. | 9ab47b10-b1ed-4ae1-94e8-09d50e952bb0 | 2026-07-21 | Warnings | M012 |
| Sleep Aid Maximum Strength | DIPHENHYDRAMINE HCL | P & L Development, LLC | 17639c3b-5d36-41f5-bd0d-da29075abd09 | 2026-07-21 | Warnings | M012 |
| NATUHEAL ORIGINAL NASAL | NAPHAZOLINE HCL 0.05% ORIGINAL NASAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a470b9e-c83f-fb20-e063-6294a90a2f13 | 2026-07-20 | Warnings | M012 |
| TYLENOL Cold plus Flu Multi-Symptom Liquid Gels Day | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Kenvue Brands LLC | 1c444202-19e9-8d04-e063-6394a90a9294 | 2026-07-20 | Warnings | M012 |
| DISCOUNT DRUG MART | COUGH DROPS HONEY LEMON | DISCOUNT DRUG MART | 5565a581-e2b5-81a5-e063-6394a90af409 | 2026-07-20 | Warnings | M012 |
| Best Choice Maximum Strength | OXYMETAZOLINE HYDROCHLORIDE | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 40e0b17a-5704-4203-8f0a-11b2fcf81f8f | 2026-07-17 | Warnings | M012 |
| Equate Daytime Vapor Ice Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | WALMART INC. | ee1ef41d-b8be-42f3-9918-ccf1c0a80241 | 2026-07-17 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 879a7804-f3d4-4a3d-bc92-b473499d6c95 | 2026-07-17 | Warnings | M012 |
| Best Choice | OXYMETAZOLINE HYDROCHLORIDE | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 95007785-ddf6-4386-af5f-84dac1066b40 | 2026-07-17 | Warnings | M012 |
| BEST CHOICE No Drip | ALLERGY SINUS | BEST CHOICE (VALU MERCHANDISERS COMPANY) | d5f95b56-8201-4d97-82ab-e23761bfe720 | 2026-07-17 | Warnings | M012 |
| Best Choice Ultra Fine Mist | OXYMETAZOLINE HYDROCHLORIDE | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 7d19fdba-35b0-424a-ba11-315521d3256d | 2026-07-17 | Warnings | M012 |
| Best Choice Maximum Strength | OXYMETAZOLINE HYDROCHLORIDE | BEST CHOICE (VALU MERCHANDISERS COMPANY) | badb15ac-91e8-4962-96f5-beb250977560 | 2026-07-17 | Warnings | M012 |
| Cough and Chest Congestion DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 0839c07b-f692-4af1-85b8-da60fb281d49 | 2026-07-17 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1661314 | dextromethorphan HBr 4 MG / guaiFENesin 50 MG / phenylephrine HCl 2.5 MG in 1 mL Oral Solution | PSN | a7c7a60d-d49f-4239-92f7-714eac7eb0c5 | 8 |
| 1661314 | dextromethorphan hydrobromide 4 MG/ML / guaifenesin 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Oral Solution | SCD | a7c7a60d-d49f-4239-92f7-714eac7eb0c5 | 8 |
Packages#
| 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 |