Over-the-counter drug · OTC MONOGRAPH DRUG
Tukol Children Cough and Congestion NDC 50066-308
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride · Dextromethorphan hydrobromide 5 mg/5mL + 2 more ingredients · Syrup · Oral · Genomma Lab USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50066-308-04 | 50066030804 | 1 BOTTLE, PLASTIC in 1 CARTON (50066-308-04) / 118 mL in 1 BOTTLE, PLASTICMarketed from Jun 1, 2022 |
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 Children Cough and Congestion
- Generic name (nonproprietary)
- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
- Active ingredients
- Dextromethorphan hydrobromide — 5 mg/5mLGuaifenesin — 50 mg/5mLPhenylephrine hydrochloride — 2.5 mg/5mL
- Dosage form
- Syrup
- Route
- Oral
- Labeler
- Genomma Lab USANDC labeler code 50066
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 50066-308_2439cdd1-e22d-530e-e063-6394a90ab78eSPL ID 2439cdd1-e22d-530e-e063-6394a90ab78eSPL set ID 235a6d2b-7302-410c-be35-4d5ff7bbdfceRxCUI 1370205UNII 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
- Pharmacologic class
- Expectorant; 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
N450066030804followed by a unit qualifier and the quantityPackage 50066-0308-04. 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 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 50066-308
- What is NDC 50066-308?
- 50066-308 is the product NDC for Tukol Children Cough and Congestion, Dextromethorphan hydrobromide 5 mg/5mL + 2 more ingredients syrup, listed with the FDA by Genomma Lab USA. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tukol Children Cough and Congestion (Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride).
- What is the active ingredient?
- Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride.
- Who is the labeler?
- Genomma Lab USA, 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 Children Cough and Congestion?
- 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 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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