NDC codes

FDA NDC Directory
Product NDC (as listed)50066-536Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50066-0536Add 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 NDC11-digit (billing)PackageCopy
50066-536-245006605362450066053624118 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

N450066053624 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

FDA NDC Directory listings under part341
ProductStrengthForm · routeLabelerProduct NDC
Broncochem Kids Allergy Controlchlorpheniramine maleate-dextromethrophan hbrChlorpheniramine maleate 2 mg/10mL; Dextromethorphan hydrobromide 10 mg/10mLSyrupOralLABORATORIO MAGANCEHM INTERNATIONAL SRL65131-418
Weeks and Leo Medicated Vaporizing Steamcamphor (synthetic)Camphor (Synthetic) .623 g/10mLLiquidRespiratory (Inhalation)Weeks & Leo Co., Inc.11383-256
Best Choice Effervescent Cold Reliefaspirin, chlorpheniramine maleate, phenylephrine bitartrateAspirin 325 mg/1 + 2 more ingredientsTablet, EffervescentOralValu Merchandiser Company63941-873
CVS Health Nighttime Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/30mLLiquidOralCVS Pharmacy,Inc.69842-753
Broncochem Maximum Coughdextromethorphan hbr-gyaifenesinDextromethorphan hydrobromide 30 mg/10mL; Guaifenesin 200 mg/10mLSyrupOralLABORATORIO MAGNACHEM INTERNATIONAL SRL65131-091
Assured Vaporizing Chest Rubcamphor and eucalyptus oil and mentholCamphor (Synthetic) 4.7 g/100g + 2 more ingredientsOintmentTopicalGreenbrier International, Inc.33992-7991
Assured Vaporizing Chest Rubcamphor and eucalyptus oil and mentholCamphor (Synthetic) 4.7 g/100g + 2 more ingredientsOintmentTopicalGreenbrier International, Inc.33992-7992
Broncochem Kids Cold And Fluacetaminophen-phenylephrine hcl-guaifenesinAcetaminophen 325 mg/10mL + 2 more ingredientsSyrupOralLABORATORIO MAGNACHEM INTERNATIONAL SRL65131-054
Broncochem Allergy Controlcholpheniramine maleate-phenylephrine hclChlorpheniramine maleate 4 mg/10mL; Phenylephrine hydrochloride 10 mg/10mLSyrupOralLABORATORIO MAGNACHEM INTERNATIONAL SRL65131-098
Diphenhydramine HydrochlorideDiphenhydramine hydrochloride 50 mg/1TabletOralAdvance Pharmaceutical Inc.17714-023
Diphenhydramine HydrochlorideDiphenhydramine hydrochloride 25 mg/1CapsuleOralAdvance Pharmaceutical Inc.17714-020
Diphenhydramine HydrochlorideDiphenhydramine hydrochloride 50 mg/1CapsuleOralAdvance Pharmaceutical Inc.17714-021
Diphenhydramine HydrochlorideDiphenhydramine hydrochloride 25 mg/1TabletOralAdvance Pharmaceutical Inc.17714-135
Childrens Multi-symptom Cold Daytimedextromethorphan hbr, guaifenesin, phenylephrine hclDextromethorphan hydrobromide 5 mg/5mL + 2 more ingredientsLiquidOralWal-Mart Stores, Inc.79903-270
Effervescent Cold Reliefaspirin, chlorpheniramine maleate, phenylephrine bitartrateAspirin 325 mg/1 + 2 more ingredientsTablet, EffervescentOralDiscount Drug Mart53943-873
Acetaminophen PMAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1TabletOralAdvance Pharmaceutical Inc.17714-133
Mucus Relief Cough and Congestion DMguaifenesin and dextromethorphan hbrDextromethorphan hydrobromide 20 mg/1; Guaifenesin 400 mg/1TabletOralAdvance Pharmaceutical Inc.17714-150
Childrens Multi-symptom Cold and Fever Liquidacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hclAcetaminophen 325 mg/10mL + 3 more ingredientsLiquidOralWal-Mart Stores, Inc.49035-772
Mucus Reliefguaifenesin 400 mgGuaifenesin 400 mg/1TabletOralAdvance Pharmaceutical Inc.17714-152
Childrens Mucus and Cough Reliefdextromethorphan hbr, guaifenesinDextromethorphan hydrobromide 5 mg/5mL; Guaifenesin 100 mg/5mLLiquidOralFamily Dollar Services, Inc.55319-924

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