Over-the-counter drug · OTC MONOGRAPH DRUG
Cold and Flu Relief NDC 70000-0515
acetaminohpen, dextromethorphan hbr, phenylephrine hcl · Acetaminophen 325 mg/1 + 2 more ingredients · Capsule, Liquid filled · Oral · CARDINAL HEALTH 110, LLC. DBA LEADER 70000
NDC codes
FDA NDC DirectoryProduct 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 NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70000-0515-1 | 7000005150170000051501 | 24 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
N470000051501followed by a unit qualifier and the quantityPackage 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.
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.
Related NDCs: other Cold and Flu Relief products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cold and Flu Reliefacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride | Acetaminophen 325 mg/15mL + 2 more ingredients | LiquidOral | WinCo Foods, LLC | 67091-471 | 67091-0471-12 |
| Cold And Flu Reliefacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | SolutionOral | Safeway | 21130-603 | 21130-0603-40 |
| Cold And Flu Reliefacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl | Acetaminophen 325 mg/15mL + 3 more ingredients | SolutionOral | Safeway | 21130-436 | 21130-0436-40 |
| Cold and Flu Reliefaconitum napellus, allium cepa, echinacea (angustifolia), euphrasia officinalis, gelsemium sempervirens, sanguinaria canadensis, sticta pulmonaria | Aconitum napellus whole 3 [hp_X]/mL + 6 more ingredients | LiquidOral | NaturalCare | 70163-0040 | 70163-0040-02 |
| Cold and Flu Reliefacetaminophen dextromethorphan hbr phenylephrine hcl | Acetaminophen 325 mg/15mL + 2 more ingredients | LiquidOral | Family Dollar (FAMILY WELLNESS) | 55319-646 | 55319-0646-12 |
| Cold and Flu Reliefacetaminophen dextromethorphan hbr phenylephrine hcl | Acetaminophen 325 mg/15mL + 2 more ingredients | LiquidOral | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-168 | 83324-0168-08 |
| Cold and Flu Reliefacetaminophen, dextromethorphan hbr, doxylamine succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-910 | 55910-0910-08 |
| Cold and Flu Reliefacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride | Acetaminophen 325 mg/15mL + 2 more ingredients | LiquidOral | Walgreens | 0363-9974 | 00363-9974-08 |
| Cold and Flu Reliefallium cepa, antimon tart, arnica, baptisia, eupatorium perf, gelsemium, kali bic, lachesis, mer iod rub, sticta , sulphur iod, urtica ur | Onion 30 [hp_C]/41mL + 11 more ingredients | LiquidOral | Eight and Company L.L.C | 61096-1002 | 61096-1002-01 |
| COLD and FLU RELIEF | Gelsemium sempervirens root 18 [hp_X]/1 + 6 more ingredients | PelletOral, Sublingual | Clineva Management Services, LLC | 71409-303 | 71409-0303-80 |
Other NDCs under M 012
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cough Reliefdextromethorphan hydrobromide | Dextromethorphan hydrobromide 15 mg/1 | Capsule, Liquid filledOral | Advanced Rx LLC | 80513-311 |
| TARGET Multi Symptom Flu Reliefacetaminophen, dextromethorphan hbr, and acetaminophen, chlorpheniramine maleate, dextromethorphan hbr | — | Kit | TARGET CORPORATION | 82442-559 |
| Geri-Dryl allergy reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | VerityRx | 83939-0683 |
| Multi Symptom Cold and Multi Symptom Nighttime Cold Childrensdextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci | — | Kit | TARGET Corporation | 11673-420 |
| Welmedix HomeCare PRO Extra Strength Rapid Rash Reliefpetrolatum, zinc oxide | Petrolatum 49 g/100g; Zinc oxide 15 g/100g | CreamTopical | Welmedix LLC | 24330-410 |
| topcare nite time cold and fluacetaminophen, dextromethorphan hbr, doxylamine succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Topco Associates LLC | 36800-143 |
| Allergy Childrensdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | H E B | 37808-012 |
| Mucus Relief Cough Childrensdextromethorphan hbr, guaifensin | Dextromethorphan hydrobromide 5 mg/5mL; Guaifenesin 100 mg/5mL | LiquidOral | H E B | 37808-594 |
| Sunmark Chest Congestion Relief DM DMdextromethorphan hydrobromide / guaifenesin | Dextromethorphan hydrobromide 20 mg/1; Guaifenesin 400 mg/1 | TabletOral | Strategic Sourcing Services LLC | 49348-728 |
| Dual Action Honey Lemon Cough Suppressant Oral Anestheticmenthol | Menthol 8.3 mg/1 | LozengeOral | Ricola Ag | 54305-323 |
| Discount drug mart Extra Moisturizingoxymetazoline hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | DISCOUNT DRUG MART | 53943-720 |
| Mucus Reliefguaifenesin | Guaifenesin 400 mg/1 | TabletOral | Geri-Care Pharmaceuticals, Corp | 57896-714 |
| Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttimeacetaminophen, diphenhydramine hcl | Acetaminophen 650 mg/20mL; Diphenhydramine hydrochloride 25 mg/20mL | LiquidOral | Haleon US Holdings LLC | 0031-0101 |
| Throat Comfort Orange Mint Cinnamon Dropsmenthol | Menthol 3.6 mg/1 | LozengeOral | Ricola USA Inc. | 63667-342 |
| Non-Drowsy Sinus Severe, Circle Kacetaminophen, guaifenesin, phenylephrine hcl caplet, film-coated | Guaifenesin 200 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Lil' Drug Store products, Inc. | 66715-5632 |
| COLD, Flu and Sore Throatacetaminophen, guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 3 more ingredients | Capsule, Liquid filledOral | Walgreens | 0363-9016 |
| Mucus Relief All in One Maximum Strengthacetaminophen, diphenhydramine hcl phenylephrine hcl | Acetaminophen 650 mg/20mL + 2 more ingredients | LiquidOral | Walgreens | 0363-9130 |
| Pyrilamine Maleate and Dextromethorphan Hydrobromide | Dextromethorphan hydrobromide 7.5 mg/5mL; Pyrilamine maleate 7.5 mg/5mL | LiquidOral | Westminster Pharmaceuticals, LLC | 69367-398 |
| Daytime Cold and Flu Relief Liquid Filled Softgelsacetaminophen, dextromethorphan hbr, phenylephrine hcl | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | AptaPharma Inc. | 76281-604 |
| Cough Dropsmenthol | Menthol 5.8 mg/1 | PastilleOral | Topco Associates LLC | 76162-016 |
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