Over-the-counter drug · OTC MONOGRAPH DRUG
Guaifenesin DM (Guaifenesin and dextromethorphan) NDC 0121-1276
Guaifenesin 200 mg/10mL; Dextromethorphan 20 mg/10mL · Syrup · Oral · PAI Holdings, LLC dba PAI Pharma
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0121-1276Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00121-1276Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0121-1276-00 | 00121127600 | 10 TRAY in 1 CASE (0121-1276-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1276-10)Marketed from Jul 1, 1992 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 200 mg/10mLDextromethorphan — 20 mg/10mL
- Dosage form
- Syrup
- Route
- Oral
- Labeler
- PAI Holdings, LLC dba PAI PharmaNDC labeler code 0121
- 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 0121-1276_c50b4c5c-6f55-4118-a282-e0b490704e49SPL ID c50b4c5c-6f55-4118-a282-e0b490704e49SPL set ID ff970fff-d1a3-4322-83b4-34e361431a1cRxCUI 996520UNII 7355X3ROTS, 495W7451VQUPC 0301210638046, 0301210638169
- 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
N400121127600followed by a unit qualifier and the quantityPackage 00121-1276-00. 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 0121-1276
- What is NDC 0121-1276?
- 0121-1276 is the product NDC for Guaifenesin DM, Guaifenesin 200 mg/10mL; Dextromethorphan 20 mg/10mL syrup, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. 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?
- PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. 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 100 mg/5mL; Dextromethorphan 10 mg/5mL | SyrupOral | Cardinal Health 107, LLC | 55154-5783 | 55154-5783-05 |
| 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 |
|---|---|---|---|---|
| equate allergy reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | WALMART INC. | 79903-297 |
| Nighttime Severe Cold and Fluacetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl | Doxylamine succinate 12.5 mg/30mL + 3 more ingredients | LiquidOral | Grocery Outlet, Inc. | 85828-775 |
| Complete Cold Reliefacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl | Acetaminophen 650 mg/20mL + 3 more ingredients | SolutionOral | Belmora LLC | 27854-299 |
| Allergy Reliefdiphenhydramine hcl 25 mg | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Lil' Drug Store Products, Inc. | 29485-9285 |
| Sinus Relief Daytime Nighttimeacetaminophen, diphenhydramine hcl, guaifenesin, phenylephrine hcl | — | Kit | Kroger Company | 30142-616 |
| nasal decongestantoxymetazoline hcl | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | A-S Medication Solutions | 50090-5281 |
| Discount drug mart Extra Moisturizingoxymetazoline hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | DISCOUNT DRUG MART | 53943-720 |
| Throat Comfort Orange Mint Cinnamon Dropsmenthol | Menthol 3.6 mg/1 | LozengeOral | Ricola Ag | 54305-342 |
| Geri-Tussin DMdextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mL | LiquidOral | Geri-Care Pharmaceuticals, Corp | 57896-661 |
| Childrens Cough and Coldchlorpheniramine maleate, dextrometrorphan hbr | Chlorpheniramine maleate 2 mg/10mL; Dextromethorphan hydrobromide 15 mg/10mL | LiquidOral | FAMILY DOLLAR SERVICES INC | 55319-754 |
| Sinus Pressure and Pain Maximum Strengthacetaminophen, phenylephrine hcl | Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 | TabletOral | DOLGENCORP, LLC | 55910-925 |
| Giltuss Sinus and Chest Congestionguaifenesin, phenylephrine hcl | Guaifenesin 388 mg/1; Phenylephrine hydrochloride 10 mg/1 | TabletOral | Gil Pharmaceutical Corp | 58552-332 |
| Robitussin Day and Night Cough Relief Value Packdextromethorphan hydrobromide, guaifenesin, chlorpheniramine maleate | — | Kit | Haleon US Holdings LLC | 0031-2099 |
| Alka-Seltzer Plus Severe Cough Mucus and Congestion Liquid Gelsalka-seltzer plus severe cough mucus and congestion | Phenylephrine hydrochloride 5 mg/1 + 3 more ingredients | Capsule, Liquid filledOral | Bayer HealthCare LLC. | 0280-0505 |
| Mucinex Childrens FreeFrom Multi-Symptom Cold and Stuffy Nosedextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride | Dextromethorphan hydrobromide 5 mg/5mL + 2 more ingredients | SolutionOral | Reckitt Benckiser LLC | 63824-956 |
| Major Nasal Decongestantoxymetazoline hydrochloride | Oxymetazoline hydrochloride .5 mg/mL | SprayNasal | NuCare Pharmaceuticals, Inc. | 68071-3858 |
| Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | Tablet, Film coatedOral | Walgreen Company | 0363-1799 |
| nighttime severe cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride | Acetaminophen 325 mg/15mL + 3 more ingredients | SolutionOral | Walgreen Company | 0363-2029 |
| Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | TabletOral | BIONPHARMA INC. | 69452-445 |
| Multi Symptom Cold and Multi Symptom Nighttime Cold Childrensdextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci | — | Kit | CVS Pharmacy | 69842-820 |
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