Over-the-counter drug · OTC MONOGRAPH DRUG
Guaifenesin DM (Guaifenesin and dextromethorphan) NDC 55154-5783
Guaifenesin 100 mg/5mL; Dextromethorphan 10 mg/5mL · Syrup · Oral · Cardinal Health 107, LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)55154-5783Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55154-5783Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-5783-5 | 5515457830555154578305 | 5 CUP, UNIT-DOSE in 1 BAG (55154-5783-5) / 10 mL in 1 CUP, UNIT-DOSEMarketed from Jul 1, 1992 |
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)
- Guaifenesin DM
- Generic name (nonproprietary)
- guaifenesin and dextromethorphan
- Active ingredients
- Guaifenesin — 100 mg/5mLDextromethorphan — 10 mg/5mL
- Dosage form
- Syrup
- Route
- Oral
- Labeler
- Cardinal Health 107, LLCNDC labeler code 55154
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 55154-5783_488e60a0-83b2-47ca-8443-c29ff3bb63a3SPL ID 488e60a0-83b2-47ca-8443-c29ff3bb63a3SPL set ID c5fd53c9-81d6-4ce6-88a0-c2c24e17a7edRxCUI 996520UNII 495W7451VQ, 7355X3ROTSUPC 0055154578356
- Pharmacologic class
- Expectorant; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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
N455154578305followed by a unit qualifier and the quantityPackage 55154-5783-05. 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 make coughs more productive • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
Excerpt only. Read the full label for complete information.
About NDC 55154-5783
- What is NDC 55154-5783?
- 55154-5783 is the product NDC for Guaifenesin DM, Guaifenesin 100 mg/5mL; Dextromethorphan 10 mg/5mL syrup, listed with the FDA by Cardinal Health 107, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Guaifenesin DM (GUAIFENESIN and DEXTROMETHORPHAN).
- What is the active ingredient?
- Guaifenesin, Dextromethorphan.
- Who is the labeler?
- Cardinal Health 107, LLC, NDC labeler code 55154. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Guaifenesin DM?
- 7 other product NDCs are listed under this name. See all Guaifenesin DM NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Guaifenesin DM products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Guaifenesin DMdextromethorphan hydrobromide,guaifenesin | Dextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mL | LiquidOral | Innovida Pharmaeutique Corporation | 71800-057 | 71800-0057-05 |
| Guaifenesin DMguaifenesin and dextromethorphan | Guaifenesin 100 mg/5mL; Dextromethorphan 10 mg/5mL | SyrupOral | American Health Packaging | 60687-817 | 60687-0817-17 |
| Guaifenesin DMguaifenesin and dextromethorphan | Guaifenesin 200 mg/10mL; Dextromethorphan 20 mg/10mL | SyrupOral | American Health Packaging | 60687-828 | 60687-0828-56 |
| Guaifenesin DMguaifenesin and dextromethorphan hydrobromide | Guaifenesin 400 mg/1; Dextromethorphan hydrobromide 20 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-801 | 43063-0801-3043063-0801-6043063-0801-90 |
| Guaifenesin DMguaifenesin and dextromethorphan | Guaifenesin 100 mg/5mL; Dextromethorphan 10 mg/5mL | SyrupOral | PAI Holdings, LLC dba PAI Pharma | 0121-0638 | 00121-0638-0000121-0638-0400121-0638-08+1 more |
| Guaifenesin DMguaifenesin and dextromethorphan | Guaifenesin 200 mg/10mL; Dextromethorphan 20 mg/10mL | SyrupOral | PAI Holdings, LLC dba PAI Pharma | 0121-1276 | 00121-1276-00 |
| Guaifenesin DMguaifenesin and dextromethorphan | Guaifenesin 100 mg/5mL; Dextromethorphan 10 mg/5mL | SyrupOral | Cardinal Health 107, LLC | 55154-5785 | 55154-5785-05 |
Other NDCs under M 012
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 |
|---|---|---|---|---|
| Cough Reliefdextromethorphan hydrobromide | Dextromethorphan hydrobromide 15 mg/1 | Capsule, Liquid filledOral | Advanced Rx LLC | 80513-311 |
| TARGET Multi Symptom Flu Reliefacetaminophen, dextromethorphan hbr, and acetaminophen, chlorpheniramine maleate, dextromethorphan hbr | — | Kit | TARGET CORPORATION | 82442-559 |
| Geri-Dryl allergy reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | VerityRx | 83939-0683 |
| Multi Symptom Cold and Multi Symptom Nighttime Cold Childrensdextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci | — | Kit | TARGET Corporation | 11673-420 |
| Welmedix HomeCare PRO Extra Strength Rapid Rash Reliefpetrolatum, zinc oxide | Petrolatum 49 g/100g; Zinc oxide 15 g/100g | CreamTopical | Welmedix LLC | 24330-410 |
| topcare nite time cold and fluacetaminophen, dextromethorphan hbr, doxylamine succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Topco Associates LLC | 36800-143 |
| Allergy Childrensdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | H E B | 37808-012 |
| Mucus Relief Cough Childrensdextromethorphan hbr, guaifensin | Dextromethorphan hydrobromide 5 mg/5mL; Guaifenesin 100 mg/5mL | LiquidOral | H E B | 37808-594 |
| Sunmark Chest Congestion Relief DM DMdextromethorphan hydrobromide / guaifenesin | Dextromethorphan hydrobromide 20 mg/1; Guaifenesin 400 mg/1 | TabletOral | Strategic Sourcing Services LLC | 49348-728 |
| Dual Action Honey Lemon Cough Suppressant Oral Anestheticmenthol | Menthol 8.3 mg/1 | LozengeOral | Ricola Ag | 54305-323 |
| Discount drug mart Extra Moisturizingoxymetazoline hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | DISCOUNT DRUG MART | 53943-720 |
| Mucus Reliefguaifenesin | Guaifenesin 400 mg/1 | TabletOral | Geri-Care Pharmaceuticals, Corp | 57896-714 |
| Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttimeacetaminophen, diphenhydramine hcl | Acetaminophen 650 mg/20mL; Diphenhydramine hydrochloride 25 mg/20mL | LiquidOral | Haleon US Holdings LLC | 0031-0101 |
| Throat Comfort Orange Mint Cinnamon Dropsmenthol | Menthol 3.6 mg/1 | LozengeOral | Ricola USA Inc. | 63667-342 |
| Non-Drowsy Sinus Severe, Circle Kacetaminophen, guaifenesin, phenylephrine hcl caplet, film-coated | Guaifenesin 200 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Lil' Drug Store products, Inc. | 66715-5632 |
| COLD, Flu and Sore Throatacetaminophen, guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 3 more ingredients | Capsule, Liquid filledOral | Walgreens | 0363-9016 |
| Mucus Relief All in One Maximum Strengthacetaminophen, diphenhydramine hcl phenylephrine hcl | Acetaminophen 650 mg/20mL + 2 more ingredients | LiquidOral | Walgreens | 0363-9130 |
| Pyrilamine Maleate and Dextromethorphan Hydrobromide | Dextromethorphan hydrobromide 7.5 mg/5mL; Pyrilamine maleate 7.5 mg/5mL | LiquidOral | Westminster Pharmaceuticals, LLC | 69367-398 |
| Daytime Cold and Flu Relief Liquid Filled Softgelsacetaminophen, dextromethorphan hbr, phenylephrine hcl | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | AptaPharma Inc. | 76281-604 |
| Cough Dropsmenthol | Menthol 5.8 mg/1 | PastilleOral | Topco Associates LLC | 76162-016 |
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