NDC codes

FDA NDC Directory
Product NDC (as listed)65852-012Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65852-0012Add 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
65852-012-0465852001204658520012041 BOTTLE, PLASTIC in 1 CARTON (65852-012-04) / 113 mL in 1 BOTTLE, PLASTICMarketed from Oct 2, 2018

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)
Giltuss Cough and Cold
Generic name (nonproprietary)
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
Active ingredients
Dextromethorphan hydrobromide — 15 mg/5mLPhenylephrine hydrochloride — 10 mg/5mLGuaifenesin — 300 mg/5mL
Dosage form
Solution
Route
Oral
Labeler
Dextrum Laboratories Inc.NDC labeler code 65852
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 65852-012_3f12ee8f-d1c7-d73a-e063-6394a90a9199SPL ID 3f12ee8f-d1c7-d73a-e063-6394a90a9199SPL set ID 3f12ee8f-d1c6-d73a-e063-6394a90a9199RxCUI 1251031UNII 9D2RTI9KYH, 04JA59TNSJ, 495W7451VQ
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

N465852001204 followed by a unit qualifier and the quantity

Package 65852-0012-04. 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)

Indication and usage section Indication and usage section Do not exceed recommended dosage, do not take more than 6 doses in any 24 hours period, keep dosing cup for use with this product, ml=mililiters. Adults and children 12 years & over 5 ml every 4 hours children 6 to under 12 years age 2.5 ml every 4 hours children 4 to 6 years of age 1.25 ml every 4 hours children under 6 years of age Consult a doctor indication an user

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65852-012

What is NDC 65852-012?
65852-012 is the product NDC for Giltuss Cough and Cold, Dextromethorphan hydrobromide 15 mg/5mL + 2 more ingredients solution, listed with the FDA by Dextrum Laboratories Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Giltuss Cough and Cold (Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride).
What is the active ingredient?
Dextromethorphan hydrobromide, Phenylephrine hydrochloride, Guaifenesin.
Who is the labeler?
Dextrum Laboratories Inc., NDC labeler code 65852. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Giltuss Cough and Cold?
2 other product NDCs are listed under this name. See all Giltuss Cough and Cold NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Giltuss Cough and Cold NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Giltuss Cough and Colddextromethorphan hbr, guaifenesin, phenylephrine hclGuaifenesin 388 mg/1 + 2 more ingredientsTabletOralGil Pharmaceutical Corp58552-33158552-0331-20
Giltuss Cough and Colddextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochlorideDextromethorphan hydrobromide 15 mg/5mL + 2 more ingredientsSolutionOralGil Pharmaceutical Corp58552-13058552-0130-04

Other NDCs under M 012

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 012
ProductStrengthForm · routeLabelerProduct NDC
Allergy Reliefdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralWALGREENS0363-0100
CVS Health No Dripnasal mistOxymetazoline hydrochloride .05 g/100mLSprayNasalCVS PHARMACY,INC.69842-815
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTIONacetaminophen, phenylephrine hydrochloride, doxylamine succinate, and dextromethorphan hydrobromideAcetaminophen 325 mg/1 + 3 more ingredientsTablet, CoatedOralThe Procter & Gamble Manufacturing Company69423-986
Cold and Flu Nighttimeacetaminophen, dextromethorphan hbr, doxylamine succinateAcetaminophen 650 mg/30mL + 2 more ingredientsSolutionOralLidl US LLC71141-180
basic care tussin dm maxdextromethorphan hbr, guaifenesinDextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mLSolutionOralAmazon.com Services LLC72288-293
Menthol Cough Drops Honey Vanilla FlavormentholMenthol 2.5 mg/1LozengeOralXiamen Kang Zhongyuan Biotechnology Co., Ltd.83698-013
equate daytime nighttime cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesen, phenylephrine hydrochloride—KitSixarp, LLC59368-459
Nasal Decongestant Maximum Strengthpseudoephedrine hclPseudoephedrine hydrochloride 30 mg/1Tablet, Film coatedOralBetter Living Brands, LLC21130-112
Medicated Chest Rubcamphor, menthol, eucalyptus oilCamphor (Synthetic) 4.8 g/100g + 2 more ingredientsCreamTopicalJell Pharmaceuticals Pvt Ltd.30400-701
equaline nighttime cold and flu reliefacetaminophen, dextromethorphan hbr, doxylamine succinateAcetaminophen 650 mg/30mL + 2 more ingredientsSolutionOralUnited Natural Foods, Inc. dba UNFI41163-459
NiteTime Cold and Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinateAcetaminophen 650 mg/30mL + 2 more ingredientsLiquidOralEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)49035-044
Childrens Dye Free Allergydiphenhydramine hydrochlorideDiphenhydramine hydrochloride 12.5 mg/5mLLiquidOralP & L Development, LLC49580-0293
Discount Drug Mart Original Nasaloxymetazoline hydrochlorideOxymetazoline hydrochloride .05 g/100mLSprayNasalDISCOUNT DRUG MART53943-715
Cold, Flu and Sore Throatacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hclAcetaminophen 650 mg/20mL + 3 more ingredientsSolutionOralFamily Dollar Services Inc55319-705
DG Health Cold and Flu Severeacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochlorideAcetaminophen 325 mg/15mL + 3 more ingredientsSolutionOralDolgencorp Inc55910-928
Robitussin Severe Multi-Symptom Cough Cold Fluacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochlorideAcetaminophen 650 mg/20mL + 3 more ingredientsLiquidOralHaleon US Holdings LLC0031-8751
Afrin No Drip Pump Mist Bundle Packoxymetazoline hydrochloride—KitNasalBayer HealthCare LLC.11523-0147
Cold Medicine XL3acetaminophen chlorpheniramine maleate phenylepherine hydrochlorideAcetaminophen 325 mg/1 + 2 more ingredientsTabletOralSelder, S.A. de C.V.63654-605
Nasal Spray, 1oz, 24/7 Life by 7-Elevenoxymetazoline hcl nasal solution 0.05%Oxymetazoline hydrochloride .05 g/100mLSprayNasalLil' Drug Store Products, Inc.66715-5526
Vicks childrens Cough Congestionphenylephrine hcl, dextromethorphan hbr, guaifenesinDextromethorphan hydrobromide 10 mg/15mL + 2 more ingredientsLiquidOralThe Procter & Gamble Manufacturing Company69423-982

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