Over-the-counter drug · OTC MONOGRAPH FINAL
Tukol A NDC 50066-536
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride · Dextromethorphan hydrobromide 5 mg/5mL + 2 more ingredients · Liquid · Oral · Genomma Lab USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50066-536-24 | 5006605362450066053624 | 118 mL in 1 BOTTLE (50066-536-24)Marketed from Jun 9, 2014 |
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)
- Tukol A
- Generic name (nonproprietary)
- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
- Active ingredients
- Dextromethorphan hydrobromide — 5 mg/5mLGuaifenesin — 50 mg/5mLPhenylephrine hydrochloride — 2.5 mg/5mL
- Dosage form
- Liquid
- Route
- Oral
- Labeler
- Genomma Lab USA, Inc.NDC labeler code 50066
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph (final)Application part341
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 50066-536_158e568c-c1da-4e77-a6a4-34062f86f1fcSPL ID 158e568c-c1da-4e77-a6a4-34062f86f1fcSPL set ID 651f0d7c-c76b-434d-95fd-427609b40b46RxCUI 1370205UNII 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJUPC 0650066000539
- Pharmacologic class
- Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; alpha-1 Adrenergic 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
N450066053624followed by a unit qualifier and the quantityPackage 50066-0536-24. 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 help loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes temporarily relieves these symptoms occurring with a cold - nasal congestion - cough due to minor throat and bronchial irritation
Excerpt only. Read the full label for complete information.
About NDC 50066-536
- What is NDC 50066-536?
- 50066-536 is the product NDC for Tukol A, Dextromethorphan hydrobromide 5 mg/5mL + 2 more ingredients liquid, listed with the FDA by Genomma Lab USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tukol A (Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride).
- What is the active ingredient?
- Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride.
- Who is the labeler?
- Genomma Lab USA, Inc., NDC labeler code 50066. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tukol A?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under part341
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 |
|---|---|---|---|---|
| Broncochem Kids Allergy Controlchlorpheniramine maleate-dextromethrophan hbr | Chlorpheniramine maleate 2 mg/10mL; Dextromethorphan hydrobromide 10 mg/10mL | SyrupOral | LABORATORIO MAGANCEHM INTERNATIONAL SRL | 65131-418 |
| Weeks and Leo Medicated Vaporizing Steamcamphor (synthetic) | Camphor (Synthetic) .623 g/10mL | LiquidRespiratory (Inhalation) | Weeks & Leo Co., Inc. | 11383-256 |
| Best Choice Effervescent Cold Reliefaspirin, chlorpheniramine maleate, phenylephrine bitartrate | Aspirin 325 mg/1 + 2 more ingredients | Tablet, EffervescentOral | Valu Merchandiser Company | 63941-873 |
| CVS Health Nighttime Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | CVS Pharmacy,Inc. | 69842-753 |
| Broncochem Maximum Coughdextromethorphan hbr-gyaifenesin | Dextromethorphan hydrobromide 30 mg/10mL; Guaifenesin 200 mg/10mL | SyrupOral | LABORATORIO MAGNACHEM INTERNATIONAL SRL | 65131-091 |
| Assured Vaporizing Chest Rubcamphor and eucalyptus oil and menthol | Camphor (Synthetic) 4.7 g/100g + 2 more ingredients | OintmentTopical | Greenbrier International, Inc. | 33992-7991 |
| Assured Vaporizing Chest Rubcamphor and eucalyptus oil and menthol | Camphor (Synthetic) 4.7 g/100g + 2 more ingredients | OintmentTopical | Greenbrier International, Inc. | 33992-7992 |
| Broncochem Kids Cold And Fluacetaminophen-phenylephrine hcl-guaifenesin | Acetaminophen 325 mg/10mL + 2 more ingredients | SyrupOral | LABORATORIO MAGNACHEM INTERNATIONAL SRL | 65131-054 |
| Broncochem Allergy Controlcholpheniramine maleate-phenylephrine hcl | Chlorpheniramine maleate 4 mg/10mL; Phenylephrine hydrochloride 10 mg/10mL | SyrupOral | LABORATORIO MAGNACHEM INTERNATIONAL SRL | 65131-098 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-023 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | CapsuleOral | Advance Pharmaceutical Inc. | 17714-020 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | Advance Pharmaceutical Inc. | 17714-021 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-135 |
| Childrens Multi-symptom Cold Daytimedextromethorphan hbr, guaifenesin, phenylephrine hcl | Dextromethorphan hydrobromide 5 mg/5mL + 2 more ingredients | LiquidOral | Wal-Mart Stores, Inc. | 79903-270 |
| Effervescent Cold Reliefaspirin, chlorpheniramine maleate, phenylephrine bitartrate | Aspirin 325 mg/1 + 2 more ingredients | Tablet, EffervescentOral | Discount Drug Mart | 53943-873 |
| Acetaminophen PM | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-133 |
| Mucus Relief Cough and Congestion DMguaifenesin and dextromethorphan hbr | Dextromethorphan hydrobromide 20 mg/1; Guaifenesin 400 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-150 |
| Childrens Multi-symptom Cold and Fever Liquidacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl | Acetaminophen 325 mg/10mL + 3 more ingredients | LiquidOral | Wal-Mart Stores, Inc. | 49035-772 |
| Mucus Reliefguaifenesin 400 mg | Guaifenesin 400 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-152 |
| Childrens Mucus and Cough Reliefdextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 5 mg/5mL; Guaifenesin 100 mg/5mL | LiquidOral | Family Dollar Services, Inc. | 55319-924 |
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