Giltuss TR
- Product NDC
- 58552-355
- 11-digit product format
- 585520355
- Labeler code
- 58552
- Product ID
- 58552-355_5d179277-c695-964e-e063-6294a90a7348
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin,Dextromethorphan HBr,Phenylephrine HCl
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Gil Pharmaceutical Corp
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-10-01
- Substance
- GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 390; 29; 10 mg/1; mg/1; mg/1
- 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
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
- Giltuss TR
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GUAIFENESIN | 390 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 29 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/1 |
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 |
|---|---|---|---|---|---|---|
| CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING | CHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBR | Haleon US Holdings LLC | becb4025-b63e-f2ea-9d11-d51fdf4e5c13 | 2025-06-04 | Warnings | M012 |
| Diphenhydramine HCL STRAWBERRY FLAVOR | DIPHENHYDRAMINE HCL | Innovida Pharmaeutique Corporation | 7eb709a5-c587-4f1d-bc2d-576d07a3a3bf | 2025-06-04 | Warnings | M012 |
| Children Allergy Relief Bubblegum flavor | DIPHENHYDRAMINE HCL | TARGET CORPORATION | 69d33f77-06e1-48fa-a516-892fdf11bb1c | 2025-06-03 | Warnings | M012 |
| oxymetazoline hydrochloride | OXYMETAZOLINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | fd058e2b-5445-e416-e053-6394a90a611b | 2025-06-03 | Warnings | M012 |
| Major Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 36b1a7e0-c8b9-0890-e063-6394a90ab13a | 2025-06-03 | Warnings | M012 |
| COLD, FLU and SORE THROAT RELIEF | ACETAMINOPHEN 650 MG, DEXTROMETHORPHAN HBR 20 MG, GUAIFENESIN 400 MG, PHENYLEPHRINE HCL 10 MG | BETTER LIVING BRANDS, LLC | 202d60a8-83da-5afc-e063-6394a90ad779 | 2025-05-31 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | TARGET CORPORATION | f935341f-1e33-d78e-e053-6294a90a348e | 2025-05-30 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HCL | AARNA USA INC. | 365bb414-8425-a900-e063-6394a90aa887 | 2025-05-30 | Warnings | M012 |
| Childrens Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | P & L Development, LLC | 8559be55-8b00-4353-8e26-b5dff2ada806 | 2025-05-30 | Warnings | M012 |
| Daytime Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Walmart Inc. | 35da8429-1f83-9e81-e063-6294a90a3515 | 2025-05-23 | Warnings | M012 |
| MAXIMUM STRENGTH COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TARGET CORP | 9dfef3dc-dbc8-659a-e053-2995a90a8c3b | 2025-05-21 | Warnings | M012 |
| Adult Tussin | GUAIFENESIN | Camber Consumer Care | 896d2540-279a-4405-b176-acbff56303e5 | 2025-05-20 | Warnings | M012 |
| Nuvicare NightTime Cold and Flu Softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | NUVICARE LLC | 37a88914-6234-4191-86f5-103c396c52af | 2025-05-20 | Warnings | M012 |
| Nuvicare DayTime Cold and Flu Softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | NUVICARE LLC | 1ea15426-4f3d-4a97-a590-6bd73bc6cbcd | 2025-05-19 | Warnings | M012 |
| Quality Choice Nasal | OXYMETAZOLINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION | 3833e781-f6ee-4c6d-8756-d8ea2293a1f2 | 2025-05-19 | Warnings | M012 |
| Quality Choice Nasal Mist Severe Congestion | OXYMETAZOLINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION | d45e99e5-ce66-4458-8d23-63a5dc7ae509 | 2025-05-19 | Warnings | M012 |
| Quality Choicel Nasal Mist Extra Moisturizing | OXYMETAZOLINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION | 460f0cc1-6a85-4d79-af87-a94fd151769e | 2025-05-19 | Warnings | M012 |
| Theraflu Flu Relief Max Strength Daytime Nighttime Combo Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 812a093f-cf83-4f7a-927a-1b5695be7f90 | 2025-05-19 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN | SDA Laboratories, Inc. | 1fd16b06-0c3e-4a30-ae6a-7b1632189c20 | 2025-05-16 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HCL | Akron Pharma Inc. | 79a6b8c7-0e81-4a46-a854-31f449042709 | 2025-05-16 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 58552-355-01 | 58552035501 | 100 TABLET in 1 BOTTLE (58552-355-01) | 100 tablet | 2026-10-01 | No | No | Current |
| 58552-355-02 | 58552035502 | 2 TABLET in 1 BLISTER PACK (58552-355-02) | 2 tablet | 2026-10-01 | No | No | Current |