Over-the-counter drug · OTC MONOGRAPH DRUG
SAFETUSSIN Non Drowsy Cough plus chest congestion NDC 55505-231
dextromethorphan hydrobromide, and guaifenesin · Dextromethorphan hydrobromide 10 mg/1; Guaifenesin 200 mg/1 · Tablet · Oral · KRAMER LABORATORIES
NDC codes
FDA NDC DirectoryProduct NDC (as listed)55505-231Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55505-0231Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55505-231-24 | 5550502312455505023124 | 24 TABLET in 1 CARTON (55505-231-24)Marketed from May 17, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- SAFETUSSIN Non Drowsy Cough plus chest congestionSuffix: Cough plus chest congestion
- Generic name (nonproprietary)
- dextromethorphan hydrobromide, and guaifenesin
- Active ingredients
- Dextromethorphan hydrobromide — 10 mg/1Guaifenesin — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- KRAMER LABORATORIESNDC labeler code 55505
- 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 55505-231_4c618596-e3fe-4557-8ccb-0867ebb871c9SPL ID 4c618596-e3fe-4557-8ccb-0867ebb871c9SPL set ID eeca6370-29ea-4540-8139-e8461d58a286RxCUI 2173726UNII 9D2RTI9KYH, 495W7451VQUPC 0053076000092
- 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
N455505023124followed by a unit qualifier and the quantityPackage 55505-0231-24. 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 temporarily relieves cough due to minor throat and bronchial irritation loosen phlegm (mucus) helps rid bronchial passages of phlegm(mucus)
Excerpt only. Read the full label for complete information.
About NDC 55505-231
- What is NDC 55505-231?
- 55505-231 is the product NDC for SAFETUSSIN Non Drowsy Cough plus chest congestion, Dextromethorphan hydrobromide 10 mg/1; Guaifenesin 200 mg/1 tablet, listed with the FDA by KRAMER LABORATORIES. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- SAFETUSSIN Non Drowsy Cough plus chest congestion (Dextromethorphan Hydrobromide, and Guaifenesin).
- What is the active ingredient?
- Dextromethorphan hydrobromide, Guaifenesin.
- Who is the labeler?
- KRAMER LABORATORIES, NDC labeler code 55505. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for SAFETUSSIN Non Drowsy Cough plus chest congestion?
- 1 other product NDC are listed under this name. See all SAFETUSSIN Non Drowsy Cough plus chest congestion NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other SAFETUSSIN Non Drowsy Cough plus chest congestion products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| SAFETUSSIN Non Drowsy Cough plus chest congestiondextromethorphan hydrobromide, and guaifenesin | Dextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mL | LiquidOral | KRAMER LABORATORIES | 55505-220 | 55505-0220-3355505-0220-36 |
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 |
|---|---|---|---|---|
| Daytime Cold and Flu Reliefacetaminohpen, dextromethorphan hbr, guaifenesin phenylephrine hcl | Acetaminophen 650 mg/30mL + 3 more ingredients | LiquidOral | The Kroger Co. | 30142-722 |
| Cold Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | — | Kit | HyVee Inc | 42507-598 |
| Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | H E B | 37808-932 |
| Medi First Plus Cherry Cough Dropsmenthol | Menthol 7.6 mg/1 | LozengeOral | Unifirst First Aid Corporation | 47682-915 |
| Supress Adexbromopheniramine maleate, dextromethorphan hbr, phenylephrine hcl | Dexbrompheniramine maleate 1 mg/mL + 2 more ingredients | SyrupOral | Kramer Novis | 52083-057 |
| Tusnel-DM Pediatricdextromethorphan hbr, guaifenesin, phenylephrine hcl | Dextromethorphan hydrobromide 2.5 mg/mL + 2 more ingredients | Solution/ dropsOral | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | 54859-606 |
| Dg Health Cold Flu Reliefacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 325 mg/15mL + 2 more ingredients | SolutionOral | Dolgencorp Inc | 55910-753 |
| Acetaminophen and Diphenhydramine citrate | Acetaminophen 500 mg/1; Diphenhydramine citrate 38 mg/1 | TabletOral | InvaTech Pharma Solutions LLC | 57631-010 |
| MUCINEX SINUS-MAX SEVERE CONGESTION RELIEF SINUS and ALLERGYoxymetazoline hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | SolutionNasal | Reckitt Benckiser LLC | 63824-120 |
| Vicks Sinex SEVERE CONGESTIONoxymetazoline hydrochloride | Oxymetazoline hydrochloride .0005 g/mL | SprayNasal | Procter & Gamble Manufacturing GmbH | 64336-002 |
| Walgreens Honey Lemon Cough Dropsmenthol | Menthol 7.5 mg/1 | LozengeOral | Walgreens | 0363-9959 |
| Tesalon Jarabe Adultoacetaminophen, dextromethorphan hbr, guaifenesin usp, phenylephrine hcl | Acetaminophen 500 mg/20mL + 3 more ingredients | SyrupOral | OPMX LLC | 69729-787 |
| Guaifenesin | Guaifenesin 400 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9616 |
| Cold Head Congestion Severeacetaminophen, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | Harris Teeter | 72036-175 |
| DG Health Cough Drops Cherry Flavormenthol | Menthol 5.8 mg/1 | LozengeTopical | Dollar General Corporation | 75712-005 |
| Nuvicare NightTime Cold and Flu Softgelacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | NUVICARE LLC | 84324-019 |
| Quality Choice Mucus Reliefguaifenesin | Guaifenesin 400 mg/1 | TabletOral | Chain Drug Marketing Association | 83324-194 |
| Diphenhydramine HCl | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | Major Pharmaceuticals | 0904-6985 |
| severe cold and flu reliefacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride | Acetaminophen 325 mg/15mL + 3 more ingredients | SolutionOral | Rite Aid Corporation | 11822-3120 |
| Supress Dx Pediatric Dropsdextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride | Dextromethorphan hydrobromide 5 mg/mL + 2 more ingredients | SyrupOral | Kramer Novis | 52083-051 |
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