NDC codes

FDA NDC Directory
Product NDC (as listed)70000-0515Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70000-0515Add 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
70000-0515-1700000515017000005150124 BLISTER PACK in 1 CARTON (70000-0515-1) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Aug 30, 2019

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Cold and Flu Relief
Generic name (nonproprietary)
acetaminohpen, dextromethorphan hbr, phenylephrine hcl
Active ingredients
Acetaminophen — 325 mg/1Dextromethorphan hydrobromide — 10 mg/1Phenylephrine hydrochloride — 5 mg/1
Dosage form
Capsule, Liquid filled
Route
Oral
Labeler
CARDINAL HEALTH 110, LLC. DBA LEADER 70000NDC labeler code 70000
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 012
Marketing start
Marketing end
Other FDA classes
Adrenergic alpha1-Agonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers
Product ID 70000-0515_a053d83a-f083-4f77-ab70-d5dfd70c1703SPL ID a053d83a-f083-4f77-ab70-d5dfd70c1703SPL set ID 82ba9a73-60ef-49fd-960f-5ca2bb79555eRxCUI 1086997UNII 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJUPC 0096295138344
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

N470000051501 followed by a unit qualifier and the quantity

Package 70000-0515-01. 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 common cold and flu symptoms minor aches and pains headache sore throat nasal congestion fever sinus pressure 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 70000-0515

What is NDC 70000-0515?
70000-0515 is the product NDC for Cold and Flu Relief, Acetaminophen 325 mg/1 + 2 more ingredients capsule, liquid filled, listed with the FDA by CARDINAL HEALTH 110, LLC. DBA LEADER 70000. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Cold and Flu Relief (ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL).
What is the active ingredient?
Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride.
Who is the labeler?
CARDINAL HEALTH 110, LLC. DBA LEADER 70000, NDC labeler code 70000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cold and Flu Relief?
10 other product NDCs are listed under this name. See all Cold and Flu Relief 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 Cold and Flu Relief NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Cold and Flu Reliefacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochlorideAcetaminophen 325 mg/15mL + 2 more ingredientsLiquidOralWinCo Foods, LLC67091-47167091-0471-12
Cold And Flu Reliefacetaminophen, dextromethorphan hydrobromide, doxylamine succinateAcetaminophen 650 mg/30mL + 2 more ingredientsSolutionOralSafeway21130-60321130-0603-40
Cold And Flu Reliefacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hclAcetaminophen 325 mg/15mL + 3 more ingredientsSolutionOralSafeway21130-43621130-0436-40
Cold and Flu Reliefaconitum napellus, allium cepa, echinacea (angustifolia), euphrasia officinalis, gelsemium sempervirens, sanguinaria canadensis, sticta pulmonariaAconitum napellus whole 3 [hp_X]/mL + 6 more ingredientsLiquidOralNaturalCare70163-004070163-0040-02
Cold and Flu Reliefacetaminophen dextromethorphan hbr phenylephrine hclAcetaminophen 325 mg/15mL + 2 more ingredientsLiquidOralFamily Dollar (FAMILY WELLNESS)55319-64655319-0646-12
Cold and Flu Reliefacetaminophen dextromethorphan hbr phenylephrine hclAcetaminophen 325 mg/15mL + 2 more ingredientsLiquidOralQUALITY CHOICE (Chain Drug Marketing Association)83324-16883324-0168-08
Cold and Flu Reliefacetaminophen, dextromethorphan hbr, doxylamine succinateAcetaminophen 325 mg/1 + 2 more ingredientsCapsule, Liquid filledOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-91055910-0910-08
Cold and Flu Reliefacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochlorideAcetaminophen 325 mg/15mL + 2 more ingredientsLiquidOralWalgreens0363-997400363-9974-08
Cold and Flu Reliefallium cepa, antimon tart, arnica, baptisia, eupatorium perf, gelsemium, kali bic, lachesis, mer iod rub, sticta , sulphur iod, urtica urOnion 30 [hp_C]/41mL + 11 more ingredientsLiquidOralEight and Company L.L.C61096-100261096-1002-01
COLD and FLU RELIEFGelsemium sempervirens root 18 [hp_X]/1 + 6 more ingredientsPelletOral, SublingualClineva Management Services, LLC71409-30371409-0303-80

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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