Over-the-counter drug · OTC MONOGRAPH DRUG
TOPCARE Childrens Cold and Cough and Runny Nose NDC 76162-792
acetaminophen, chlorpheniramine maleate, and dextromethorphan hydrobromide · Chlorpheniramine maleate 1 mg/5mL + 2 more ingredients · Suspension · Oral · Topco Associates, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76162-792-04 | 7616207920476162079204 | 1 BOTTLE in 1 CARTON (76162-792-04) / 120 mL in 1 BOTTLEMarketed from Aug 12, 2024 |
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)
- TOPCARE Childrens Cold and Cough and Runny NoseSuffix: Childrens Cold and Cough and Runny Nose
- Generic name (nonproprietary)
- acetaminophen, chlorpheniramine maleate, and dextromethorphan hydrobromide
- Active ingredients
- Chlorpheniramine maleate — 1 mg/5mLDextromethorphan hydrobromide — 5 mg/5mLAcetaminophen — 160 mg/5mL
- Dosage form
- Suspension
- 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
- Histamine H1 Receptor Antagonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 76162-792_434f84ba-ba81-a4e6-e063-6394a90ae042SPL ID 434f84ba-ba81-a4e6-e063-6394a90ae042SPL set ID 8931d4ca-c599-49be-87e1-8c0598f38b77RxCUI 1086750UNII V1Q0O9OJ9Z, 9D2RTI9KYH, 362O9ITL9D
- Pharmacologic class
- Histamine-1 Receptor Antagonist; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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
N476162079204followed by a unit qualifier and the quantityPackage 76162-0792-04. 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 temporarily relieves the following cold/flu symptoms: minor aches and pains headache sore throat sneezing and runny nose cough temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 76162-792
- What is NDC 76162-792?
- 76162-792 is the product NDC for TOPCARE Childrens Cold and Cough and Runny Nose, Chlorpheniramine maleate 1 mg/5mL + 2 more ingredients suspension, 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?
- TOPCARE Childrens Cold and Cough and Runny Nose (Acetaminophen, Chlorpheniramine Maleate, and Dextromethorphan Hydrobromide).
- What is the active ingredient?
- Chlorpheniramine maleate, Dextromethorphan hydrobromide, Acetaminophen.
- 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 TOPCARE Childrens Cold and Cough and Runny Nose?
- 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 |
|---|---|---|---|---|
| MGC Health Cough Drops Honey Herbmenthol | Menthol 4.8 mg/1 | LozengeOral | Medical Group Care LLC | 83173-133 |
| Multi-Symptom Cold And Flu Relief Nighttimeacetaminophen 325 mg dextromethorphan hbr 15 mg doxylamine succinate 6.25 mg | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | RITE AID | 11822-1987 |
| daytime severe cold and fluacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl | Acetaminophen 325 mg/15mL + 3 more ingredients | SolutionOral | Kroger Company | 30142-603 |
| TopCare Allergy Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | TOPCO ASSOCIATES LLC | 36800-367 |
| Daytime Cold And Fludextromethorphan hydrobromide, acetaminophen, phenylephrine hydrochloride | Dextromethorphan hydrobromide 10 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Kroger Company | 41226-693 |
| Allergy Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | FOODHOLD U.S.A., LLC | 41520-290 |
| good sense tussin dmdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 200 mg/20mL | SolutionOral | A-S Medication Solutions | 50090-7257 |
| Sanatosmenthol | Menthol 5.4 mg/1 | LozengeOral | Pharmadel LLC | 55758-518 |
| Cough Dropsmenthol | Menthol 7.5 mg/1 | PastilleOral | The Kroger CO | 59450-716 |
| Vicks NyQuil VapoCOOL COLD and FLUacetaminophen, doxylamine succinate, dextromethorphan hydrobromide | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | Navajo Manufacturing Company Inc. | 67751-244 |
| Childrens Allergy Relief | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | Allegiant Health | 69168-471 |
| Severe Cold Plus Flu Daytime Nighttimeacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and doxylamine succinate | — | Kit | CVS Pharmacy,Inc. | 69842-546 |
| Sinus Pressure and Pain Maximum Strengthacetaminophen, phenylephrine hcl | Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 | TabletOral | Cardinal Health 110, LLC. DBA Leader | 70000-0161 |
| Mucus Reliefguaifenesin 400 mg | Guaifenesin 400 mg/1 | TabletOral | Pioneer Life Sciences, LLC | 72090-035 |
| Mucinex Childrens Night Time Multi-Symptom Cold and Fluacetaminophen, dextromethorphan hbr, triprolidine hcl | Triprolidine hydrochloride 1.25 mg/10mL + 2 more ingredients | SolutionOral | Reckitt Benckiser LLC | 72854-063 |
| Pharbinex-DMguaifenesin 400mg and dextromethorphan hbr 20mg | Guaifenesin 400 mg/1; Dextromethorphan hydrobromide 20 mg/1 | TabletOral | Ulai Health LLC | 73057-381 |
| MAXIMUM STRENGTH Sinus Relief Day and Night SOFTGELS - 24 ctacetaminophen, dextromethorphan hydrobromide, guaifenesin, doxylamine succinate, phenylephrine hydrochloride | — | Kit | Topco Associates LLC | 76162-679 |
| 24/7 Life Medicated Chest Rubcamphor, eucalyptus oil, menthol ointment | Eucalyptus oil 1.2 g/100g + 2 more ingredients | OintmentTopical | Lil' Drug Store Products, Inc. | 29485-6536 |
| Daytime and Nighttime Cherry Cold and Fludaytime - acetaminophen, dextromethorphan hbr, phenylephrine hcl nighttime - acetaminophen, dextromethorphan hbr, doxylamine succinate | — | KitOral | BETTER LIVING BRANDS, LLC | 21130-967 |
| Daytime Nighttimeacetaminophen, guaifenesin, acetaminophen, dextromethorphan hbr, triprolidine hcl | — | Kit | KROGER COMPANY | 41226-678 |
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