Over-the-counter drug · OTC MONOGRAPH DRUG
Guaifenesin NDC 0121-2232
Guaifenesin 300 mg/15mL · Solution · Oral · PAI Holdings, LLC dba PAI Pharma
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0121-2232Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00121-2232Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0121-2232-00 | 00121223200 | 10 TRAY in 1 CASE (0121-2232-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-2232-15)Marketed from Sep 1, 2002 |
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
- Generic name (nonproprietary)
- guaifenesin
- Active ingredients
- Guaifenesin — 300 mg/15mL
- Dosage form
- Solution
- 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)
- Identifiers
- Product ID 0121-2232_25a970c7-0016-4f22-9e94-1e20e1319e3eSPL ID 25a970c7-0016-4f22-9e94-1e20e1319e3eSPL set ID c2e53fb5-2798-47c8-9285-d1077d46e629RxCUI 310604UNII 495W7451VQ
- 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
N400121223200followed by a unit qualifier and the quantityPackage 00121-2232-00. 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.
Excerpt only. Read the full label for complete information.
About NDC 0121-2232
- What is NDC 0121-2232?
- 0121-2232 is the product NDC for Guaifenesin, Guaifenesin 300 mg/15mL solution, 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.
- What is the active ingredient?
- Guaifenesin.
- 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?
- 62 other product NDCs are listed under this name. See all Guaifenesin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Guaifenesin 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 | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-857 | 58602-0857-93 |
| Guaifenesinguaifenesin 400 mg | Guaifenesin 200 mg/1 | TabletOral | Zennova LLC | 81993-002 | 81993-0002-0181993-0002-0281993-0002-03+2 more |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | TOPCO ASSOCIATES LLC | 76162-031 | 76162-0031-56 |
| Guaifenesin | Guaifenesin 600 mg/1 | TabletOral | YYBA CORP | 73581-400 | 73581-0400-0273581-0400-07 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Sam's West Inc | 68196-960 | 68196-0960-56 |
| Guaifenesin | Guaifenesin 100 mg/5mL | LiquidOral | KESIN PHARMA CORPORATION | 81033-102 | 81033-0102-16 |
| Guaifenesin | Guaifenesin 100 mg/5mL | SolutionOral | American Health Packaging | 60687-852 | 60687-0852-17 |
| Guaifenesin | Guaifenesin 200 mg/10mL | SolutionOral | American Health Packaging | 60687-863 | 60687-0863-56 |
| Guaifenesin | Guaifenesin 300 mg/15mL | SolutionOral | American Health Packaging | 60687-874 | 60687-0874-16 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | GRANULES USA, INC. | 69848-018 | 69848-0018-16 |
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 |
|---|---|---|---|---|
| Childrens Benadryl ALLERGYdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | Kenvue Brands LLC | 50580-534 |
| Cold Maxacetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | DISCOUNT DRUG MART | 53943-138 |
| Kroger DayTime Cold and Flu SOFTGELacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | The Kroger Co. | 59450-046 |
| CVS Overnight Cold and Flu Clear and Coolacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride | Acetaminophen 650 mg/20mL + 3 more ingredients | SolutionOral | CVS PHARMACY, INC | 69842-966 |
| Sinus Head Congestionacetaminophen, phenylephrine hydrochloride | Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 | Capsule, Liquid filledOral | VIVUNT PHARMA LLC | 82706-025 |
| Leader Cough Drops Vanilla Honeymenthol | Menthol, Unspecified form 2.5 mg/1 | LozengeOral | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 83698-692 |
| Allergy Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | HEB | 37808-590 |
| Oxymetazoline Hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | Bi-Mart | 37835-996 |
| Vaporxcamphor (synthetic), eucalyptus oil, and menthol | Camphor (Synthetic) .048 g/g + 2 more ingredients | OintmentTopical | AKRON PHARMA INC | 71399-4589 |
| Global Care 4Oz Vapor Rubmenthol, camphor, eucalyptus oil | Menthol 1 g/100g + 2 more ingredients | OintmentTopical | GLOBAL IMPORT SALES LLC | 72146-008 |
| Adult Allergy Reliefcalmco allergy relief | Diphenhydramine hydrochloride 25 mg/1 | Bar, ChewableOral | CalmCo | 73282-2520 |
| Severe cold and flu Nighttimeacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hci | Acetaminophen 650 mg/30mL + 3 more ingredients | LiquidOral | P & L Development, LLC | 49580-4160 |
| Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-packacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and guaifenesin, phenylephrine hydrochloride | — | Kit | Kenvue Brands LLC | 50580-526 |
| Daytime and Nighttimeacetaminophen, guaifenesin, dextromethorphan hbr, doxylamine succinate | — | KitOral | CVS HEALTH CORP | 51316-961 |
| Alka-Seltzer Plus Severe Cold Powerfast Fizz Nightaspirin, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine bitartrate | Aspirin 500 mg/1 + 3 more ingredients | Tablet, EffervescentOral | Bayer HealthCare LLC. | 0280-0021 |
| Sinus Pressure plus Pain PEacetaminophen and phenylephrine hydrochloride | Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 | Tablet, CoatedOral | VALU MERCHANDISERS COMPANY | 63941-220 |
| Daytime Cold And Flu Multi-Symptom Reliefacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | CapsuleOral | Chain Drug Consortium, LLC | 68016-877 |
| Sugar Free Cough Drops Black Cherrymenthol | Menthol 5.8 mg/1 | PastilleOral | Cardinal Health 110, Inc. | 70000-0643 |
| Multi-Symptom Cold childrensdextromethorphan hbr, guaifenesin, phenylephrine hcl | Dextromethorphan hydrobromide 5 mg/5mL + 2 more ingredients | SolutionOral | WALMART INC. | 79903-176 |
| AXIV DayTime - Liquidacetaminophen, dextromethorphan hydrobromide | Acetaminophen 650 mg/30mL; Dextromethorphan hydrobromide 20 mg/30mL | LiquidOral | VIVUNT PHARMA LLC | 82706-022 |
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