Over-the-counter drug · OTC MONOGRAPH DRUG
Daytime Cold and Flu Relief NDC 76162-065
Acetaminophen 325 mg/1 + 2 more ingredients · Capsule, Liquid filled · Oral · TopCo Associates, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76162-065-16 | 7616200651676162006516 | 1 BLISTER PACK in 1 CARTON (76162-065-16) / 16 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Nov 3, 2023 |
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)
- Daytime Cold and Flu Relief
- Generic name (nonproprietary)
- daytime cold and flu relief
- Active ingredients
- Acetaminophen — 325 mg/1Dextromethorphan hydrobromide — 10 mg/1Phenylephrine hydrochloride — 5 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- TopCo Associates, LLCNDC labeler code 76162
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 76162-065_97e61aee-34b7-468d-b3ea-6d796d4365daSPL ID 97e61aee-34b7-468d-b3ea-6d796d4365daSPL set ID d592fbb8-d4bf-444e-982e-edf6fe97dce4RxCUI 1086997UNII 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJUPC 0036800367333
- 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
N476162006516followed by a unit qualifier and the quantityPackage 76162-0065-16. 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)
Use(s) temporarily relieves common cold/flu symptoms: • nasal congestion • cough due to minor throat & bronchial irritation • sore throat • headache • minor aches & pains • fever
Excerpt only. Read the full label for complete information.
About NDC 76162-065
- What is NDC 76162-065?
- 76162-065 is the product NDC for Daytime Cold and Flu Relief, Acetaminophen 325 mg/1 + 2 more ingredients capsule, liquid filled, listed with the FDA by TopCo Associates, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Daytime Cold and Flu Relief.
- What is the active ingredient?
- Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride.
- Who is the labeler?
- TopCo Associates, LLC, NDC labeler code 76162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Daytime Cold and Flu Relief?
- 8 other product NDCs are listed under this name. See all Daytime 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 Daytime 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) |
|---|---|---|---|---|---|
| Daytime Cold And Flu Reliefacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride | Acetaminophen 325 mg/15mL + 2 more ingredients | SolutionOral | Safeway | 21130-638 | 21130-0638-40 |
| Daytime Cold and Flu Reliefacetaminophen, dextromethorphan hbr, phenylephrine hcl | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | SALADO SALES INC. | 57243-604 | 57243-0604-03 |
| Daytime Cold and Flu Reliefacetaminophen dextromethorphan hbr | Acetaminophen 325 mg/15mL; Dextromethorphan hydrobromide 10 mg/15mL | LiquidOral | Family Dollar (FAMILY WELLNESS) | 55319-954 | 55319-0954-12 |
| Daytime Cold And Flu Reliefacetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Advanced Rx LLC | 80513-303 | 80513-0303-50 |
| Daytime Cold and Flu Reliefacetaminophen, dextromethorphan hbr, phenylephrine hcl | Acetaminophen 325 mg/1 + 2 more ingredients | CapsuleOral | BETTER LIVING BRANDS LLC. | 21130-900 | 21130-0900-24 |
| Daytime Cold and Flu Reliefacetaminohpen, dextromethorphan hbr, phenylephrine hcl | Acetaminophen 325 mg/15mL + 2 more ingredients | LiquidOral | CVS PHARMACY | 51316-617 | 51316-0617-12 |
| Daytime Cold and Flu Reliefacetaminohpen, dextromethorphan hbr, guaifenesin phenylephrine hcl | Acetaminophen 650 mg/30mL + 3 more ingredients | LiquidOral | WALGREENS CO. | 0363-7270 | 00363-7270-12 |
| Daytime Cold and Flu Reliefacetaminohpen, dextromethorphan hbr, guaifenesin phenylephrine hcl | Acetaminophen 650 mg/30mL + 3 more ingredients | LiquidOral | The Kroger Co. | 30142-722 | 30142-0722-12 |
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 |
|---|---|---|---|---|
| Daytime Cold and Flu Reliefacetaminohpen, dextromethorphan hbr, guaifenesin phenylephrine hcl | Acetaminophen 650 mg/30mL + 3 more ingredients | LiquidOral | The Kroger Co. | 30142-722 |
| Cold Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | — | Kit | HyVee Inc | 42507-598 |
| Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | H E B | 37808-932 |
| Medi First Plus Cherry Cough Dropsmenthol | Menthol 7.6 mg/1 | LozengeOral | Unifirst First Aid Corporation | 47682-915 |
| Supress Adexbromopheniramine maleate, dextromethorphan hbr, phenylephrine hcl | Dexbrompheniramine maleate 1 mg/mL + 2 more ingredients | SyrupOral | Kramer Novis | 52083-057 |
| SAFETUSSIN Non Drowsy Cough plus chest congestiondextromethorphan hydrobromide, and guaifenesin | Dextromethorphan hydrobromide 10 mg/1; Guaifenesin 200 mg/1 | TabletOral | KRAMER LABORATORIES | 55505-231 |
| Tusnel-DM Pediatricdextromethorphan hbr, guaifenesin, phenylephrine hcl | Dextromethorphan hydrobromide 2.5 mg/mL + 2 more ingredients | Solution/ dropsOral | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | 54859-606 |
| Dg Health Cold Flu Reliefacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 325 mg/15mL + 2 more ingredients | SolutionOral | Dolgencorp Inc | 55910-753 |
| Acetaminophen and Diphenhydramine citrate | Acetaminophen 500 mg/1; Diphenhydramine citrate 38 mg/1 | TabletOral | InvaTech Pharma Solutions LLC | 57631-010 |
| MUCINEX SINUS-MAX SEVERE CONGESTION RELIEF SINUS and ALLERGYoxymetazoline hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | SolutionNasal | Reckitt Benckiser LLC | 63824-120 |
| Vicks Sinex SEVERE CONGESTIONoxymetazoline hydrochloride | Oxymetazoline hydrochloride .0005 g/mL | SprayNasal | Procter & Gamble Manufacturing GmbH | 64336-002 |
| Walgreens Honey Lemon Cough Dropsmenthol | Menthol 7.5 mg/1 | LozengeOral | Walgreens | 0363-9959 |
| Tesalon Jarabe Adultoacetaminophen, dextromethorphan hbr, guaifenesin usp, phenylephrine hcl | Acetaminophen 500 mg/20mL + 3 more ingredients | SyrupOral | OPMX LLC | 69729-787 |
| Guaifenesin | Guaifenesin 400 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9616 |
| Cold Head Congestion Severeacetaminophen, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | Harris Teeter | 72036-175 |
| DG Health Cough Drops Cherry Flavormenthol | Menthol 5.8 mg/1 | LozengeTopical | Dollar General Corporation | 75712-005 |
| Nuvicare NightTime Cold and Flu Softgelacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | NUVICARE LLC | 84324-019 |
| Quality Choice Mucus Reliefguaifenesin | Guaifenesin 400 mg/1 | TabletOral | Chain Drug Marketing Association | 83324-194 |
| Diphenhydramine HCl | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | Major Pharmaceuticals | 0904-6985 |
| severe cold and flu reliefacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride | Acetaminophen 325 mg/15mL + 3 more ingredients | SolutionOral | Rite Aid Corporation | 11822-3120 |
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