NDC codes

FDA NDC Directory
Product NDC (as listed)36800-143Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0143Add 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
36800-143-62368000143623680001436212 BLISTER PACK in 1 CARTON (36800-143-62) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Feb 2, 2014

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 nite time cold and flu
Generic name (nonproprietary)
acetaminophen, dextromethorphan hbr, doxylamine succinate
Active ingredients
Acetaminophen — 325 mg/1Dextromethorphan hydrobromide — 15 mg/1Doxylamine succinate — 6.25 mg/1
Dosage form
Capsule, Liquid filled
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
Histamine Receptor Antagonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers
Product ID 36800-143_77dfcc34-4ae3-4910-b469-19d84ddd71c4SPL ID 77dfcc34-4ae3-4910-b469-19d84ddd71c4SPL set ID 516ab016-31f9-4829-8b94-2f968933093cRxCUI 1094549UNII 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2
Pharmacologic class
Antihistamine; 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

N436800014362 followed by a unit qualifier and the quantity

Package 36800-0143-62. 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/flu symptoms: • cough due to minor throat and bronchial irritation • sore throat • headache • minor aches and pains • fever • runny nose and sneezing

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 36800-143

What is NDC 36800-143?
36800-143 is the product NDC for topcare nite time cold and flu, 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?
topcare nite time cold and flu (Acetaminophen, Dextromethorphan HBr, Doxylamine succinate).
What is the active ingredient?
Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate.
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 topcare nite time cold and flu?
4 other product NDCs are listed under this name. See all topcare nite time cold and flu 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 topcare nite time cold and flu NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Topcare Nite Time Cold And Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinateAcetaminophen 325 mg/1 + 2 more ingredientsTablet, Film coatedOralTopco Associates LLC76162-61976162-0619-62
topcare nite time cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochlorideAcetaminophen 325 mg/15mL + 3 more ingredientsSolutionOralTopco Associates LLC76162-20276162-0202-40
topcare nite time cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochlorideAcetaminophen 325 mg/1 + 3 more ingredientsTablet, Film coatedOralTopco Associates LLC36800-30736800-0307-62
topcare nite time cold and fluacetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hclAcetaminophen 650 mg/30mL + 3 more ingredientsSolutionOralTopco Associates LLC36800-29136800-0291-40

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
Cough Reliefdextromethorphan hydrobromideDextromethorphan hydrobromide 15 mg/1Capsule, Liquid filledOralAdvanced Rx LLC80513-311
TARGET Multi Symptom Flu Reliefacetaminophen, dextromethorphan hbr, and acetaminophen, chlorpheniramine maleate, dextromethorphan hbr—KitTARGET CORPORATION82442-559
Geri-Dryl allergy reliefdiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralVerityRx83939-0683
Multi Symptom Cold and Multi Symptom Nighttime Cold Childrensdextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci—KitTARGET Corporation11673-420
Welmedix HomeCare PRO Extra Strength Rapid Rash Reliefpetrolatum, zinc oxidePetrolatum 49 g/100g; Zinc oxide 15 g/100gCreamTopicalWelmedix LLC24330-410
Allergy Childrensdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 12.5 mg/5mLLiquidOralH E B37808-012
Mucus Relief Cough Childrensdextromethorphan hbr, guaifensinDextromethorphan hydrobromide 5 mg/5mL; Guaifenesin 100 mg/5mLLiquidOralH E B37808-594
Sunmark Chest Congestion Relief DM DMdextromethorphan hydrobromide / guaifenesinDextromethorphan hydrobromide 20 mg/1; Guaifenesin 400 mg/1TabletOralStrategic Sourcing Services LLC49348-728
Dual Action Honey Lemon Cough Suppressant Oral AnestheticmentholMenthol 8.3 mg/1LozengeOralRicola Ag54305-323
Discount drug mart Extra Moisturizingoxymetazoline hydrochlorideOxymetazoline hydrochloride .05 g/100mLSprayNasalDISCOUNT DRUG MART53943-720
Mucus ReliefguaifenesinGuaifenesin 400 mg/1TabletOralGeri-Care Pharmaceuticals, Corp57896-714
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttimeacetaminophen, diphenhydramine hclAcetaminophen 650 mg/20mL; Diphenhydramine hydrochloride 25 mg/20mLLiquidOralHaleon US Holdings LLC0031-0101
Throat Comfort Orange Mint Cinnamon DropsmentholMenthol 3.6 mg/1LozengeOralRicola USA Inc.63667-342
Non-Drowsy Sinus Severe, Circle Kacetaminophen, guaifenesin, phenylephrine hcl caplet, film-coatedGuaifenesin 200 mg/1 + 2 more ingredientsTablet, Film coatedOralLil' Drug Store products, Inc.66715-5632
COLD, Flu and Sore Throatacetaminophen, guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochlorideAcetaminophen 325 mg/1 + 3 more ingredientsCapsule, Liquid filledOralWalgreens0363-9016
Mucus Relief All in One Maximum Strengthacetaminophen, diphenhydramine hcl phenylephrine hclAcetaminophen 650 mg/20mL + 2 more ingredientsLiquidOralWalgreens0363-9130
Pyrilamine Maleate and Dextromethorphan HydrobromideDextromethorphan hydrobromide 7.5 mg/5mL; Pyrilamine maleate 7.5 mg/5mLLiquidOralWestminster Pharmaceuticals, LLC69367-398
Daytime Cold and Flu Relief Liquid Filled Softgelsacetaminophen, dextromethorphan hbr, phenylephrine hclAcetaminophen 325 mg/1 + 2 more ingredientsCapsule, Liquid filledOralAptaPharma Inc.76281-604
Cough DropsmentholMenthol 5.8 mg/1PastilleOralTopco Associates LLC76162-016
Daytime Cold And Flu Reliefacetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochlorideAcetaminophen 325 mg/1 + 2 more ingredientsCapsule, Liquid filledOralAdvanced Rx LLC80513-303

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