Over-the-counter drug · OTC MONOGRAPH DRUG
Cold Plus Head Congestion Nighttime NDC 36800-925
Acetaminophen 325 mg/1 + 3 more ingredients · Tablet, Coated · Oral · TopCo Associates LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)36800-925Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0925Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-925-02 | 3680009250236800092502 | 2 BLISTER PACK in 1 CARTON (36800-925-02) / 12 TABLET, COATED in 1 BLISTER PACKMarketed from Aug 30, 2011 |
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)
- Cold Plus Head Congestion Nighttime
- Generic name (nonproprietary)
- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride
- Active ingredients
- Acetaminophen — 325 mg/1Chlorpheniramine maleate — 2 mg/1Dextromethorphan hydrobromide — 10 mg/1Phenylephrine hydrochloride — 5 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- TopCo Associates LLCNDC labeler code 36800
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 36800-925_28600825-1272-8434-e063-6394a90acf63SPL ID 28600825-1272-8434-e063-6394a90acf63SPL set ID 7854c1fd-b5fc-477d-a79e-ff006ebf6fe5RxCUI 1086991UNII 362O9ITL9D, V1Q0O9OJ9Z, 9D2RTI9KYH, 04JA59TNSJ
- Pharmacologic class
- Histamine-1 Receptor Antagonist; 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
N436800092502followed by a unit qualifier and the quantityPackage 36800-0925-02. 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 for the temporary relief of the following cold symptoms: minor aches and pains headache sore throat nasal congestion runny nose and sneezing cough sinus congestion and pressure helps clear nasal passages relieves cough to help you sleep temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 36800-925
- What is NDC 36800-925?
- 36800-925 is the product NDC for Cold Plus Head Congestion Nighttime, Acetaminophen 325 mg/1 + 3 more ingredients tablet, coated, 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?
- Cold Plus Head Congestion Nighttime (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE).
- What is the active ingredient?
- Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride.
- Who is the labeler?
- TopCo Associates LLC, NDC labeler code 36800. 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 Plus Head Congestion Nighttime?
- 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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