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.
| 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 |
|---|---|
| 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 |
|---|---|---|---|---|---|---|
| ACTIDOGESIC | DEXBROMPHENIRAMINE MALEATE, ACETAMINOPHEN | ACTIPHARMA, LLC | 697da3f9-9888-4d41-ba83-87ca9bf1e54b | 2025-08-18 | Warnings | M012 |
| Night Time Cold and Flu Relief Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Rite Aid Corporation | 5f9c9c48-4e8f-4ace-a6fb-1c1bccaf02a0 | 2025-08-18 | Warnings | M012 |
| MAJOR NASAL DECONGESTANT | OXYMETAZOLINE HYDROCHLORIDE | A-S Medication Solutions | 4b78b9af-0975-43f8-8b44-daddef0478be | 2025-08-15 | Warnings | M012 |
| Dr Simi Mucus Relief Expectorant | GUAIFENESIN | Farmacias De Similares TX LLC | 3c6d0e75-a685-6020-e063-6294a90a5c1b | 2025-08-15 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Rite Aid Corporation | 25bf4390-23f7-4bb6-b86e-c40eaf8d92da | 2025-08-15 | Warnings | M012 |
| Childrens Chewable Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | KROGER COMPANY | 2cac72be-4830-ad49-e063-6394a90a7832 | 2025-08-14 | Warnings | M012 |
| GOOD NEIGHBOR PHARMACY MUCUS RELIEF DM MAXIMUM STRENGTH | DEXTROMETHORPHAN HBR AND GUAIFENESIN | AMERISOURCE BERGEN | 2ea1e7bf-1bb9-4627-bbd4-4a78920a8b6e | 2025-08-12 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Walmart Inc. | 16fae164-28db-8ef1-e063-6294a90ab5da | 2025-08-12 | Warnings | M012 |
| Exchange Select Cough Drops Original Herb | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | fbece335-a7e5-4732-a086-561b23741579 | 2025-08-12 | Warnings | M012 |
| MGC Health Cough Drops Original Herb | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 779ddb89-b6e2-4bfb-bcb5-8c7ec916675a | 2025-08-12 | Warnings | M012 |
| Equaline Nasal | OXYMETAZOLINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | d7fa1720-eac4-4e82-9401-77215ce4f545 | 2025-08-12 | Warnings | M012 |
| Diabetic Tussin DM Maximum Strength | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | MEDTECH PRODUCTS INC | a10a3b33-7503-4334-8ed7-2bb881df4327 | 2025-08-08 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health, Inc | 26a55d74-f772-5d17-e063-6394a90a5583 | 2025-08-07 | Warnings | M012 |
| Daytime Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | H E B | b7434978-44a8-4c51-979d-0bc446461e43 | 2025-08-06 | Warnings | M012 |
| Tussin DM | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS Pharmacy | fc1e224c-5c57-43fc-ae6e-36aa0a4ae439 | 2025-08-06 | Warnings | M012 |
| childrens cold cough dm | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Publix Super Markets Inc | 6efe7097-2a99-4654-9d94-b47f2e64d19d | 2025-08-05 | Warnings | M012 |
| Quality Choice Throat Soothing Drops Creamy Strawberry | PECTIN | Chain Drug Marketing Association, Inc. | 3b7548ee-7cd3-62c3-e063-6294a90a0612 | 2025-08-03 | Warnings | M012 |
| Vaporizing chest rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | LJ Pharma | 065bb666-e482-4e96-ac75-c6577dcc5b48 | 2025-08-01 | Warnings | M012 |
| Nighttime Cough-Kids | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Genexa | 024bb864-4214-1d8b-e063-6394a90aa573 | 2025-08-01 | Warnings | M012 |
| Antigrip Cough and Cold | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Pharmadel LLC | 3b53e5fc-f258-c2b9-e063-6394a90ab500 | 2025-08-01 | 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 |