Giltuss EX Expectorant
- Product NDC
- 65852-008
- 11-digit product format
- 658520008
- Labeler code
- 65852
- Product ID
- 65852-008_3f67ac3d-1504-3418-e063-6394a90a938f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Dextrum Laboratories Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-06-22
- Substance
- GUAIFENESIN
- Active strength
- 400 mg/10mL
- Pharmacologic classes
- Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 EX Expectorant
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GUAIFENESIN | 400 mg/10mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 495W7451VQ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 310625 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3f67ac3d-1503-3418-e063-6394a90a938f | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65852-008-04 | Giltuss EX Expectorant | 118 mL in 1 BOTTLE, PLASTIC | SOLUTION | 118 | 1 | |
| 65852-008-04 | Giltuss EX Expectorant | 1 in 1 CARTON | SOLUTION | 1 | 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 |
|---|---|---|---|---|---|---|
| Severe Sinus Relief Mist | OXYMETAZOLINE SPRAY | Walgreens Company | 847f47d9-62b1-49a3-8bb3-9bf275685bd2 | 2024-02-14 | Warnings | M012 |
| Allergy Sinus, Lil Drug Store | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE | Lil' Drug Store Products, Inc. | 1145440e-b37a-6e5e-e063-6294a90ab4a0 | 2024-02-13 | Warnings | M012 |
| Guaifenesin and Codeine Phosphate | GUAIFENESIN AND CODEINE PHOSPHATE | A-S Medication Solutions | 36140639-e7a8-43bc-83e2-469430af9d1a | 2024-02-13 | Warnings | M012 |
| Theraflu ExpressMax Daytime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Haleon US Holdings LLC | ff48b55a-0d32-47d6-941d-d99c7cf52f94 | 2024-02-12 | Warnings | M012 |
| Childrens Robitussin Cough and Chest Congestion DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Haleon US Holdings LLC | 15950273-14c9-4a0b-bbb4-683048add722 | 2024-02-08 | Warnings | M012 |
| THERAFLU Severe Cold Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 7d902237-a990-4c5e-875b-291e124e143b | 2024-02-03 | Warnings | M012 |
| Tussin Cough and Chest Congestion DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Best Choice (Valu Merchandisers Company) | 0f2d371d-f890-41e5-ac11-db5559d32466 | 2024-02-02 | Warnings | M012 |
| Theraflu Severe Cold Relief Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 4daca846-8511-4303-9e6c-9469f7f260ba | 2024-02-02 | Warnings | M012 |
| CVS Health COUGH SUPPRESSANT SOFTGEL | DEXTROMETHORPHAN HYDROBROMIDE | CVS Pharmacy, Inc. | f676dfeb-fba8-419d-8a47-c3880e4100cc | 2024-02-02 | Warnings | M012 |
| Nighttime Cold and Flu ReadyInCase | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | P & L Development, LLC | 155a7168-b568-41f4-b8a2-214889b4eccf | 2024-02-02 | Warnings | M012 |
| Vaporizing Chest Rub Lavender 4oz | CAMPHOR/MENTHOL | Rejoice International Corp. | 104e1a38-3472-b9e2-e063-6294a90a38cf | 2024-02-01 | Warnings | M012 |
| Vaporizing Chest Rub Lavender 4oz | CAMPHOR/MENTHOL | China Ningbo Shangge Cosmetics Technology Corp. | 104f5b07-eed2-566c-e063-6294a90a6505 | 2024-02-01 | Warnings | M012 |
| CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | AptaPharma Inc. | 5962a73e-72e4-493b-94a7-43bc6cf9c82f | 2024-02-01 | Warnings | M012 |
| good sense allergy relief | DIPHENHYDRAMINE HYDROCHLORIDE | L. Perrigo Company | 2cfa69b4-e33f-442a-a6df-b021b041da14 | 2024-02-01 | Warnings | M012 |
| Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | e5ef7b85-feee-44a7-bd0e-ed91352c7434 | 2024-01-31 | Warnings | M012 |
| SEVERE CONGESTION and COUGH MAX | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | AptaPharma Inc. | 17a07d2d-f2da-4e51-9a77-6f0c174987bb | 2024-01-31 | Warnings | M012 |
| Maximum strength Max Cold and Sinus | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | AptaPharma Inc. | 263dae13-5f92-4505-8bcc-e903d05b9a0c | 2024-01-31 | Warnings | M012 |
| THERAFLU POWERPODS NIGHTTIME SEVERE COLD | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 39f9feef-4bf2-4f10-9fff-22bbb1d8a471 | 2024-01-30 | Warnings | M012 |
| Theraflu Daytime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE | Haleon US Holdings LLC | c0689223-5c90-4dbc-bbfa-f94e267504c3 | 2024-01-28 | Warnings | M012 |
| THERAFLU MULTI-SYMPTOM SEVERE COLD | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Haleon US Holdings LLC | a4c56ca0-7785-404b-996d-137cc135f270 | 2024-01-28 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310625 | guaiFENesin 200 MG in 5 mL Oral Solution | PSN | 3f67ac3d-1503-3418-e063-6394a90a938f | 1 |
| 310625 | guaifenesin 40 MG/ML Oral Solution | SCD | 3f67ac3d-1503-3418-e063-6394a90a938f | 1 |
| 310625 | guaifenesin 200 MG per 5 ML Oral Solution | SY | 3f67ac3d-1503-3418-e063-6394a90a938f | 1 |
| 310625 | guaifenesin 400 MG per 10 ML Oral Solution | SY | 3f67ac3d-1503-3418-e063-6394a90a938f | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 65852-008-04 | 65852000804 | 1 BOTTLE, PLASTIC in 1 CARTON (65852-008-04) / 118 mL in 1 BOTTLE, PLASTIC | 2020-06-22 | No | No | Current |