What is NDC 0121-1775?

0121-1775 is the product NDC for Guaifenesin and Codeine Phosphate, Guaifenesin 100 mg/5mL; Codeine phosphate 10 mg/5mL solution, listed with the FDA by PAI Holdings, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Guaifenesin, Codeine phosphate.

PAI Holdings, LLC, 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 and Codeine Phosphate?

5 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Guaifenesin and Codeine Phosphate NDC 0121-1775

NDC codes

FDA NDC Directory

Product NDC (as listed)0121-1775Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00121-1775Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
0121-1775-00	00121177500	10 TRAY in 1 CASE (0121-1775-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1775-05)Marketed from Oct 1, 2006
0121-1775-10	00121177510	10 TRAY in 1 CASE (0121-1775-10) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSEMarketed from Oct 1, 2006
0121-1775-40	00121177540	4 TRAY in 1 CASE (0121-1775-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1775-05)Marketed from Jan 10, 2024

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 and Codeine Phosphate
Generic name (nonproprietary): guaifenesin and codeine phosphate
Active ingredients: Guaifenesin — 100 mg/5mLCodeine phosphate — 10 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: PAI Holdings, LLCNDC labeler code 0121
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 012
Marketing start: Oct 1, 2006
Listing expires: Dec 31, 2026
DEA schedule: CV
Other FDA classes: Decreased Respiratory Secretion Viscosity (Physiologic effect)Full Opioid Agonists (Mechanism)Increased Respiratory Secretions (Physiologic effect)
Identifiers: Product ID 0121-1775_2175415b-f07e-50a6-e063-6394a90acabeSPL ID 2175415b-f07e-50a6-e063-6394a90acabeSPL set ID 88d0994c-4270-4408-8837-bd97510b2118RxCUI 995868UNII GSL05Y1MN6, 495W7451VQ
Pharmacologic class: Expectorant; Opioid Agonist

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

N400121177500 followed by a unit qualifier and the quantity

Package 00121-1775-00. 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 Sep 6, 2024.

Indications (excerpt from the label)

Uses temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0121-1775

What is NDC 0121-1775?: 0121-1775 is the product NDC for Guaifenesin and Codeine Phosphate, Guaifenesin 100 mg/5mL; Codeine phosphate 10 mg/5mL solution, listed with the FDA by PAI Holdings, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Guaifenesin and Codeine Phosphate.
What is the active ingredient?: Guaifenesin, Codeine phosphate.
Who is the labeler?: PAI Holdings, LLC, 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 and Codeine Phosphate?: 5 other product NDCs are listed under this name. See all Guaifenesin and Codeine Phosphate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Guaifenesin and Codeine Phosphate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Guaifenesin and Codeine Phosphate	Codeine phosphate 10 mg/5mL; Guaifenesin 100 mg/5mL	SolutionOral	Cardinal Health 107, LLC	55154-5791	55154-5791-05
Guaifenesin and Codeine Phosphate	Guaifenesin 100 mg/5mL; Codeine phosphate 10 mg/5mL	SolutionOral	Preferred Pharmaceuticals Inc.	68788-8361	68788-8361-01
Guaifenesin and Codeine Phosphate	Guaifenesin 100 mg/5mL; Codeine phosphate 10 mg/5mL	SolutionOral	PAI Holdings, LLC	0121-0775	00121-0775-0400121-0775-16
Guaifenesin and Codeine Phosphate	Guaifenesin 200 mg/10mL; Codeine phosphate 20 mg/10mL	SolutionOral	PAI Holdings, LLC	0121-1550	00121-1550-0000121-1550-40
Guaifenesin and Codeine Phosphate	Guaifenesin 100 mg/5mL; Codeine phosphate 10 mg/5mL	SolutionOral	A-S Medication Solutions	50090-1428	50090-1428-00

Other NDCs under M 012

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 012
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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