Mucolyte
- Product NDC
- 57237-359
- 11-digit product format
- 572370359
- Labeler code
- 57237
- Product ID
- 57237-359_ab35cca0-adaa-4e57-bd51-b29528cb8358
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-12-22
- 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
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
- Mucolyte
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GUAIFENESIN | 100 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 495W7451VQ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 310604 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e4091aaf-44e3-4701-9986-aff248a2f1b8 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57237-359-12 | Mucolyte | 118 mL in 1 BOTTLE | LIQUID | 118 | 1 | |
| 57237-359-16 | Mucolyte | 473 mL in 1 BOTTLE | LIQUID | 473 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57237-359-12 | ML - Milliliter | 57237-359 | aa46343d-4ab1-42be-a72d-e8e5258dc8c0 | 1 | 2026-01-08 |
| 57237-359-16 | ML - Milliliter | 57237-359 | faaec639-f255-498e-8333-a18d14e1f40f | 1 | 2026-01-08 |
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 |
|---|---|---|---|---|---|---|
| Mucus Relief Immediate Release | GUAIFENESIN 400MG | TopCo Associates, LLC | 7d91c6ab-d161-42b9-b353-0aa8f59619f8 | 2021-01-21 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN 325MG/ DEXTROMETHORPHAN HBR 10MG/ PHENYLEPHRINE HCL 5MG | Allegiant Health | bed5f9dc-45ea-4e90-86c6-86599b6f3861 | 2020-11-16 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN | Allegiant Health | b97126d7-847d-483e-b3d1-e2b61ab1743f | 2020-11-11 | Warnings | M012 |
| Cold and Allergy | PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE | Allegiant Health | 7af63769-fa56-4f1f-a2ad-5b4c108c8e4f | 2019-12-12 | Warnings | M012 |
| Mucus Relief Immediate Release | GUAIFENESIN | Allegiant Health | 221d64a2-b8c7-435a-aae4-fb58fd38108f | 2019-03-26 | Warnings | M012 |
| Sleep Tabs For Nighttime use | DIPHENHYDRAMINE HCL TABLETS | Allegiant Health | 566e40b1-e9d7-44e4-b971-eef2b7cf0a7d | 2018-12-26 | Warnings | M012 |
| Allergy | CHLORPHENIRAMINE MALEATE | Allegiant Health | 4305ad50-d2a5-4d3e-9d92-cbf26e856a16 | 2018-12-26 | Warnings | M012 |
| Sleep Aid | DIPHENHYDRAMINE HCL 25 MG | Allegiant Health | dbbc535f-515a-4d9b-b799-34e60f5230bb | 2018-12-21 | Warnings | M012 |
| Allergy | DIPHENHYDRAMINE HCL | Allegiant Health | c2823bad-540f-4662-8dcc-58e9f0d94efb | 2018-11-07 | Warnings | M012 |
| Nasal Decongestant PE Maximum Strength Non-Drowsy | PHENYLEPHRINE 10 MG | Allegiant Health | 7aef00df-816a-4ea2-a2ad-beed66dd2fe4 | 2018-11-07 | Warnings | M012 |
| DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDE | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Westminster Pharmaceuticals, LLC | a58bfb14-28f9-4425-a5a5-aaff4847c979 | 2018-03-14 | Warnings | M012 |
| Chlorpheniramine maleate 4mg | CHLORPHENIRAMINE MALEATE 4MG | Athlete's Needs, Inc. | 4d974959-25fc-4707-9b72-9afbf47b76f1 | 2017-11-14 | Warnings | M012 |
| Cold Medicine | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Selder, S.A. de C.V. | d2762d9c-e7e7-42b2-a26a-14b2aa0307cb | 2017-01-25 | Warnings | M012 |
| Allergy | CHLORPHENIRAMINE MALEATE | Marc Glassman, Inc. | 2051247f-ce64-4cf5-b449-9ca14c43ab86 | 2016-12-27 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310604 | guaiFENesin 100 MG in 5 mL Oral Solution | PSN | e4091aaf-44e3-4701-9986-aff248a2f1b8 | 1 |
| 310604 | guaifenesin 20 MG/ML Oral Solution | SCD | e4091aaf-44e3-4701-9986-aff248a2f1b8 | 1 |
| 310604 | guaifenesin 100 MG per 5 ML Oral Solution | SY | e4091aaf-44e3-4701-9986-aff248a2f1b8 | 1 |
| 310604 | guaifenesin 100 MG per 5 ML Oral Syrup | SY | e4091aaf-44e3-4701-9986-aff248a2f1b8 | 1 |
| 310604 | guaifenesin 200 MG per 10 ML Oral Solution | SY | e4091aaf-44e3-4701-9986-aff248a2f1b8 | 1 |
| 310604 | guaifenesin 300 MG per 15 ML Oral Solution | SY | e4091aaf-44e3-4701-9986-aff248a2f1b8 | 1 |
| 310604 | guaifenesin 400 MG per 20 ML Oral Solution | SY | e4091aaf-44e3-4701-9986-aff248a2f1b8 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 57237-359-12 | 57237035912 | 118 mL in 1 BOTTLE (57237-359-12) | 118 ml | 2025-12-22 | No | No | Current |
| 57237-359-16 | 57237035916 | 473 mL in 1 BOTTLE (57237-359-16) | 473 ml | 2025-12-22 | No | No | Current |