Guaifenesin
- Product NDC
- 58657-508
- 11-digit product format
- 586570508
- Labeler code
- 58657
- Product ID
- 58657-508_41b51a4b-65a5-778b-e063-6294a90ae4a9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Method Pharmaceuticals, LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-04-01
- Substance
- GUAIFENESIN
- Active strength
- 100 mg/5mL
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Guaifenesin
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GUAIFENESIN | 100 mg/5mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 495W7451VQ |
| Rxcui | 310604 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 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 |
| ed912195-5da0-0f2f-6f4b-3ef17710cbe3 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58657-508-16 | Guaifenesin | 473 mL in 1 BOTTLE | LIQUID | 473 | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310604 | guaiFENesin 100 MG in 5 mL Oral Solution | PSN | 1e9887f6-209f-4f1f-9afa-a5ca649721cb | 5 |
| 310604 | guaifenesin 20 MG/ML Oral Solution | SCD | 1e9887f6-209f-4f1f-9afa-a5ca649721cb | 5 |
| 310604 | guaifenesin 100 MG per 5 ML Oral Solution | SY | 1e9887f6-209f-4f1f-9afa-a5ca649721cb | 5 |
| 310604 | guaifenesin 100 MG per 5 ML Oral Syrup | SY | 1e9887f6-209f-4f1f-9afa-a5ca649721cb | 5 |
| 310604 | guaifenesin 200 MG per 10 ML Oral Solution | SY | 1e9887f6-209f-4f1f-9afa-a5ca649721cb | 5 |
| 310604 | guaifenesin 300 MG per 15 ML Oral Solution | SY | 1e9887f6-209f-4f1f-9afa-a5ca649721cb | 5 |
| 310604 | guaifenesin 400 MG per 20 ML Oral Solution | SY | 1e9887f6-209f-4f1f-9afa-a5ca649721cb | 5 |
| 310604 | guaiFENesin 100 MG in 5 mL Oral Solution | PSN | 1539c3d4-d982-7d4e-e063-6394a90ad7d6 | 3 |
| 310604 | guaifenesin 20 MG/ML Oral Solution | SCD | 1539c3d4-d982-7d4e-e063-6394a90ad7d6 | 3 |
| 310604 | guaifenesin 100 MG per 5 ML Oral Solution | SY | 1539c3d4-d982-7d4e-e063-6394a90ad7d6 | 3 |
| 310604 | guaifenesin 100 MG per 5 ML Oral Syrup | SY | 1539c3d4-d982-7d4e-e063-6394a90ad7d6 | 3 |
| 310604 | guaifenesin 200 MG per 10 ML Oral Solution | SY | 1539c3d4-d982-7d4e-e063-6394a90ad7d6 | 3 |
| 310604 | guaifenesin 300 MG per 15 ML Oral Solution | SY | 1539c3d4-d982-7d4e-e063-6394a90ad7d6 | 3 |
| 310604 | guaifenesin 400 MG per 20 ML Oral Solution | SY | 1539c3d4-d982-7d4e-e063-6394a90ad7d6 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 58657-508-16 | 58657050816 | 473 mL in 1 BOTTLE (58657-508-16) | 473 ml | 2024-04-01 | No | No | Current |