What is NDC 76162-619?

76162-619 is the product NDC for Topcare Nite Time Cold And Flu, Acetaminophen 325 mg/1 + 2 more ingredients tablet, film 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?

Topcare Nite Time Cold And Flu (Acetaminophen, dextromethorphan hydrobromide, doxylamine succinate).

What is the active ingredient?

Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate.

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 Nite Time Cold And Flu?

4 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Topcare Nite Time Cold And Flu NDC 76162-619

NDC codes

FDA NDC Directory

Product NDC (as listed)76162-619Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76162-0619Add 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 NDC	11-digit (billing)	Package	Copy
76162-619-62	76162061962	12 BLISTER PACK in 1 CARTON (76162-619-62) / 2 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jul 24, 2026

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 hydrobromide, doxylamine succinate
Active ingredients: Acetaminophen — 325 mg/1Dextromethorphan hydrobromide — 10 mg/1Doxylamine succinate — 6.25 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Topco Associates LLCNDC labeler code 76162
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 012
Marketing start: Jul 24, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Histamine Receptor Antagonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers: Product ID 76162-619_59ffa1c1-bdd4-488c-b78b-2fd921fe18c9SPL ID 59ffa1c1-bdd4-488c-b78b-2fd921fe18c9SPL set ID 905d1c5c-65c8-47a3-ad7a-61a4b4b98f0dRxCUI 2713312UNII 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

N476162061962 followed by a unit qualifier and the quantity

Package 76162-0619-62. 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 Jul 29, 2026.

Indications (excerpt from the label)

Uses • temporarily relieves common cold/flu symptoms: • cough due to minor throat and bronchial irritation • cough to help you sleep • 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 76162-619

What is NDC 76162-619?: 76162-619 is the product NDC for Topcare Nite Time Cold And Flu, Acetaminophen 325 mg/1 + 2 more ingredients tablet, film 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?: Topcare Nite Time Cold And Flu (Acetaminophen, dextromethorphan hydrobromide, doxylamine succinate).
What is the active ingredient?: Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate.
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 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
topcare nite time cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride	Acetaminophen 325 mg/15mL + 3 more ingredients	SolutionOral	Topco Associates LLC	76162-202	76162-0202-40
topcare nite time cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride	Acetaminophen 325 mg/1 + 3 more ingredients	Tablet, Film coatedOral	Topco Associates LLC	36800-307	36800-0307-62
topcare nite time cold and fluacetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl	Acetaminophen 650 mg/30mL + 3 more ingredients	SolutionOral	Topco Associates LLC	36800-291	36800-0291-40
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	36800-0143-62

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
Product	Strength	Form · route	Labeler	Product NDC
Childrens Benadryl ALLERGYdiphenhydramine hydrochloride	Diphenhydramine hydrochloride 12.5 mg/5mL	SolutionOral	Kenvue Brands LLC	50580-534
Cold Maxacetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride	Acetaminophen 325 mg/1 + 2 more ingredients	Tablet, CoatedOral	DISCOUNT DRUG MART	53943-138
Kroger DayTime Cold and Flu SOFTGELacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride	Acetaminophen 325 mg/1 + 2 more ingredients	Capsule, Liquid filledOral	The Kroger Co.	59450-046
CVS Overnight Cold and Flu Clear and Coolacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride	Acetaminophen 650 mg/20mL + 3 more ingredients	SolutionOral	CVS PHARMACY, INC	69842-966
Sinus Head Congestionacetaminophen, phenylephrine hydrochloride	Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1	Capsule, Liquid filledOral	VIVUNT PHARMA LLC	82706-025
Leader Cough Drops Vanilla Honeymenthol	Menthol, Unspecified form 2.5 mg/1	LozengeOral	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	83698-692
Allergy Reliefdiphenhydramine hydrochloride	Diphenhydramine hydrochloride 25 mg/1	Tablet, CoatedOral	HEB	37808-590
Oxymetazoline Hydrochloride	Oxymetazoline hydrochloride .05 g/100mL	SprayNasal	Bi-Mart	37835-996
Vaporxcamphor (synthetic), eucalyptus oil, and menthol	Camphor (Synthetic) .048 g/g + 2 more ingredients	OintmentTopical	AKRON PHARMA INC	71399-4589
Global Care 4Oz Vapor Rubmenthol, camphor, eucalyptus oil	Menthol 1 g/100g + 2 more ingredients	OintmentTopical	GLOBAL IMPORT SALES LLC	72146-008
Adult Allergy Reliefcalmco allergy relief	Diphenhydramine hydrochloride 25 mg/1	Bar, ChewableOral	CalmCo	73282-2520
Severe cold and flu Nighttimeacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hci	Acetaminophen 650 mg/30mL + 3 more ingredients	LiquidOral	P & L Development, LLC	49580-4160
Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-packacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and guaifenesin, phenylephrine hydrochloride	—	Kit	Kenvue Brands LLC	50580-526
Daytime and Nighttimeacetaminophen, guaifenesin, dextromethorphan hbr, doxylamine succinate	—	KitOral	CVS HEALTH CORP	51316-961
Alka-Seltzer Plus Severe Cold Powerfast Fizz Nightaspirin, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine bitartrate	Aspirin 500 mg/1 + 3 more ingredients	Tablet, EffervescentOral	Bayer HealthCare LLC.	0280-0021
Sinus Pressure plus Pain PEacetaminophen and phenylephrine hydrochloride	Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1	Tablet, CoatedOral	VALU MERCHANDISERS COMPANY	63941-220
Daytime Cold And Flu Multi-Symptom Reliefacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride	Acetaminophen 325 mg/1 + 2 more ingredients	CapsuleOral	Chain Drug Consortium, LLC	68016-877
Sugar Free Cough Drops Black Cherrymenthol	Menthol 5.8 mg/1	PastilleOral	Cardinal Health 110, Inc.	70000-0643
Multi-Symptom Cold childrensdextromethorphan hbr, guaifenesin, phenylephrine hcl	Dextromethorphan hydrobromide 5 mg/5mL + 2 more ingredients	SolutionOral	WALMART INC.	79903-176
AXIV DayTime - Liquidacetaminophen, dextromethorphan hydrobromide	Acetaminophen 650 mg/30mL; Dextromethorphan hydrobromide 20 mg/30mL	LiquidOral	VIVUNT PHARMA LLC	82706-022

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