G-SUPRESS DX PEDIATRIC DROPS
- Product NDC
- 52083-651
- 11-digit product format
- 520830651
- Labeler code
- 52083
- Product ID
- 52083-651_415366fa-2a35-40e2-927d-8ed94cde28e6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Kramer Novis
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-10-06
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 5; 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
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
- G-SUPRESS DX PEDIATRIC DROPS
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 5 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 |
|---|---|
| 1095503 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 676cc9ae-b7e6-4458-aaa5-2be7dbfdf7e9 | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| COLD FLU AND SORE THROAT | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES , LLC. | 9f960566-0158-6637-e053-2995a90a9c4a | 2024-10-15 | Warnings | M012 |
| HEAD CONGESTION PLUS FLU SEVERE PE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES , LLC. | e65cf21d-3d69-a53e-e053-2a95a90a1c83 | 2024-10-15 | Warnings | M012 |
| night time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | H E B | 49f5f4d3-556c-4ee3-b5cd-5331dd434bb9 | 2024-10-15 | Warnings | M012 |
| Mielim y mas | DEXTROMETHORPHAN | Efficient Laboratories Inc. | 711d1dae-3af4-46af-a3a8-cd827356a81a | 2024-10-14 | Warnings | M012 |
| Tukol Cough and Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA | 27ab3d86-e960-4d83-aad1-d50d2c8e02a9 | 2024-10-14 | Warnings | M012 |
| HealthWise Chest Rub Lavender | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Veridian Healthcare | 2472ce85-c701-4fcd-e063-6394a90a2765 | 2024-10-14 | Warnings | M012 |
| HealthWise Chest Rub Lemon | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Veridian Healthcare | 24740d5a-aba1-0bd4-e063-6394a90ab2ca | 2024-10-14 | Warnings | M012 |
| Childrens Plus Cough and Runny Nose | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ea059b56-dc9a-4a6b-8c16-5dfcdaf4cd43 | 2024-10-14 | Warnings | M012 |
| Theraflu Severe Cold Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENPHYDRAMINE HCL, GUAIFENESIN | Haleon US Holdings LLC | b01cc9f5-53f2-40d8-acf1-6de180b3d0bf | 2024-10-14 | Warnings | M012 |
| Cough Relief Adult | DEXTROMETHORPHAN HBR | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | f5c57b32-69cb-469e-ad2d-64c00b5e66dc | 2024-10-14 | Warnings | M012 |
| Nasal Decongestant | PSEUDOEPHEDRINE HCL | Publix Super Markets Inc | 94c21df5-c631-4748-a833-288b2298055c | 2024-10-12 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Chain Drug Marketing Association | 8eab9d79-69c1-44b8-9145-a7ebd887d54d | 2024-10-11 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Chain Drug Marketing Association | e4963eec-fb4a-425c-be19-f514b4f10a7f | 2024-10-11 | Warnings | M012 |
| Severe Sinus Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Chain Drug Marketing Association | 1b4e87f8-3f9e-4865-9128-527d2d621593 | 2024-10-11 | Warnings | M012 |
| Mucus Relief Cold and Flu All in One | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC | ff433512-55b7-4fc9-8a55-aff5cbb749ef | 2024-10-11 | Warnings | M012 |
| Mucus Relief Cold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC | 3170354a-4752-49a0-97ed-3d9db266a059 | 2024-10-11 | Warnings | M012 |
| Tukol Children Cough and Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA | 235a6d2b-7302-410c-be35-4d5ff7bbdfce | 2024-10-11 | Warnings | M012 |
| Night Time Cold and Flu Relief Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | CVS Pharmacy | 6c7b0ea6-bff9-4fd2-9e00-64015c326ee8 | 2024-10-11 | Warnings | M012 |
| nitetime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Meijer Distribution Inc | dcc12bc2-4bb4-4d2d-8206-b9db9843ec8b | 2024-10-11 | Warnings | M012 |
| Signature Care Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | Safeway | 838d2f11-2ee4-4081-98c8-b87e79aa47c4 | 2024-10-11 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 52083-651-01 | 52083065101 | 1 BOTTLE in 1 CARTON (52083-651-01) / 30 mL in 1 BOTTLE | 1 bottle | 2026-10-06 | No | No | Current |