Over-the-counter drug · ANDA
365 Whole Foods Market Guaifenesin NDC 42681-0057
guaifenesin · Guaifenesin 600 mg/1 · Tablet, Extended release · Oral · Whole Foods Market, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42681-0057-1 | 42681005701 | 1 BOTTLE in 1 CARTON (42681-0057-1) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Jan 23, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- 365 Whole Foods Market Guaifenesin
- Generic name (nonproprietary)
- guaifenesin
- Active ingredients
- Guaifenesin — 600 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Whole Foods Market, Inc.
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210453
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
- Identifiers
- Product ID 42681-0057_7c890031-8188-48be-bb69-06db0e01a0c0SPL ID 7c890031-8188-48be-bb69-06db0e01a0c0SPL set ID 7c890031-8188-48be-bb69-06db0e01a0c0RxCUI 636522UNII 495W7451VQUPC 0099482547868
- Pharmacologic class
- Expectorant
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N442681005701followed by a unit qualifier and the quantityPackage 42681-0057-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210453
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | VESPYR BRANDS LLC | 71179-002 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-853 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-857 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-864 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-865 |
| Mucus Relief Maxguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Better Living Brands, LLC | 21130-399 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Sam's West Inc | 68196-960 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | TOPCO ASSOCIATES LLC | 76162-031 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | WALGREEN CO. | 0363-0028 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | RITE AID CORPORATION | 11822-4260 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | WALGREEN CO. | 0363-0033 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | BluePoint Laboratories | 68001-561 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Better Living Brands LLC | 21130-179 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-811 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-810 |