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topcare nite time cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL Solution, 355 mL — NDC 36800-459-40 (Billing 36800-0459-40)

by Topco Associates LLC · 355 mL in 1 BOTTLE

This is a package of 355 mL of topcare nite time cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL Solution from Topco Associates LLC, marketed since Aug 2011 and currently FDA-listed.

NDC 36800-0459-40
🏷️ FDA NDC (as labeled) 36800-459-40 billing pads the product segment with a zero
This package
Contains355 mL Pack sizes2 compare ↓
Product page 36800-0459-34 Also comes in: 237 ml 36800-459-34
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 36800-459-40
Product NDC 36800-459
11-digit billing NDC 36800045940
RxCUI 1043400
UNII 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2
Application # M012
SPL Set ID f868e4a0-e9fb-4e6a-9984-29a218246241
Established class (EPC) Antihistamine; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of action Histamine Receptor Antagonists; Sigma-1 Receptor Agonists; Uncompetitive NMDA Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-08-19
Route ORAL
Dosage form SOLUTION
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Quick answers
  • RxCUI (RxNorm): 1043400
Why two NDCs? The FDA registers this code as 36800-459-40 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 36800-0459-40. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Anilides class.

Drug family (ATC) Anilides
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

🧪 What is this product?

TopCare Nite Time Cold and Flu Relief is an oral liquid solution sold over the counter under FDA's OTC monograph rules. It contains acetaminophen, a pain reliever and fever reducer; dextromethorphan, a cough suppressant; and doxylamine succinate, a sedating antihistamine. Products containing these ingredients are typically used to relieve multiple nighttime cold and flu symptoms, such as aches, fever, cough, and congestion, often with the added effect of promoting drowsiness to aid sleep.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 237 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
36800-0459-34 36800-459-34 Main listing 237 mL in 1 BOTTLE 2012-07-11 — Active
36800-0459-40 You're viewing this 355 mL in 1 BOTTLE 2012-07-10 — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 355 mL — 355 ml in 1 bottle.
How does this package differ from NDC 36800-0459-34?
Both are topcare nite time cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL Solution — the drug itself is identical. This page's package is the 355 mL one, while NDC 36800-0459-34 is the 237 ml package.
What NDC number is used to bill for this package of topcare nite time cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Leader Nighttime Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 70000-0183-01 Cardinal 355 ml $0.009 — Discontinued —
foster and thrive nighttime cold and flu relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 70677-1032-01 Strategic 355 ml $0.011 — Availability likely —
Leader Nighttime Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 70000-0184-01 Cardinal 237 ml $0.015 — FDA listed —
good sense night time 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 00113-0335-34 L. 237 ml $0.015 — Availability likely —
all nite 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 00904-6465-09 Major 237 ml $0.015 — Availability likely —
good neighbor pharmacy night time 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 46122-0136-34 Amerisource 237 ml $0.015 — Availability likely —
good neighbor pharmacy night time cold and flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 46122-0198-34 Amerisource 237 ml $0.015 — Availability likely —
foster and thrive nighttime cold and flu relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 70677-1033-01 Strategic 237 ml $0.015 — Availability likely —
good sense nighttime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 00113-0459-34 L. 237 ml — — FDA listed —
Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 00363-0401-34 Walgreen 237 ml — — Discontinued —
Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 00363-0566-34 Walgreen 237 ml — — Discontinued —
Cold and Flu Nighttime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 00363-3430-12 Walgreens 355 ml — — FDA listed —
Walgreen High Blood Pressure Nighttime Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 00363-6210-08 WALGREENS 236 ml — — FDA listed —
Cold and Flu Night 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 00363-9913-02 Walgreen 355 ml — — FDA listed —
Nighttime Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 00363-9975-08 Walgreens 237 ml — — FDA listed —
Nighttime Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 00363-9976-08 Walgreens 237 ml — — FDA listed —
Coricidin HBP Nighttime Multi-Symptom Cold 6.25 mg/15mL; 325 mg/15mL; 15 mg/15mL 11523-4358-01 Bayer 355 ml — — FDA listed —
up and up nighttime cold and flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 11673-0019-40 Target 355 ml — — Discontinued —
Nighttime Cold and Flu Liquid 650 mg/30mL; 12.5 mg/30mL; 30 mg/30mL 11673-0287-01 TARGET 354 ml — — FDA listed —
Nighttime Cherry Cold and Flu 30 mg/30mL; 650 mg/30mL; 12.5 mg/30mL 11673-0312-01 TARGET 354 ml — — FDA listed —
Nighttime Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 11822-3318-00 Rite 355 ml — — FDA listed —
Cold and Flu Relief Nighttime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 11822-5832-01 Rite 237 ml — — FDA listed —
Nighttime Cold and Flu Relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 21130-0044-08 Safeway, 237 ml — — FDA listed —
Nighttime Cold and Flu Relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 21130-0343-08 Safeway, 237 ml — — FDA listed —
Cold And Flu Relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 21130-0603-40 Safeway 355 ml — — FDA listed —
Nighttime Cherry Cold And Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 21130-0907-02 BETTER 2 bottles — — FDA listed —
Nighttime Cold and Flu 12.5 mg/30mL; 650 mg/30mL; 30 mg/30mL 21130-0951-06 BETTER 236 ml — — FDA listed —
Kroger Nighttime Cold and Flu Relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 30142-0292-12 Kroger 354 ml — — FDA listed —
Nighttime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 30142-0335-40 Kroger 354 ml — — FDA listed —
NightTime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 30142-0459-40 Kroger 354 ml — — Discontinued —
Night Time Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 30142-0634-12 The 355 ml — — Discontinued —
topcare nite time cold and flu relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 36800-0335-34 Topco 237 ml — — FDA listed —
topcare nite time cold and flu relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mLthis 36800-0459-40 Topco 355 ml — — FDA listed —
night time cold and flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 37808-0335-34 H 237 ml — — FDA listed —
night time 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 37808-0459-38 H 296 ml — — Discontinued —
Cold and Flu Nighttime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 37835-0524-02 Bi-Mart 355 ml — — FDA listed —
Nighttime Cold And Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 37835-0525-12 BI-MART 355 ml — — FDA listed —
equaline nighttime cold and flu relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 41163-0335-40 United 355 ml — — FDA listed —
Nighttime Cold and Flu 30 mg/30mL; 12.5 mg/30mL; 650 mg/30mL 41226-0750-01 Kroger 354 ml — — FDA listed —
Nighttime Cold and Flu 12.5 mg/30mL; 650 mg/30mL; 30 mg/30mL 41226-0782-01 Kroger 354 ml — — FDA listed —
nitetime cold and flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 41250-0335-40 Meijer 355 ml — — FDA listed —
nitetime cold and flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 41250-0459-40 Meijer 355 ml — — FDA listed —
CareOne Night TIme Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 41520-0084-40 American 355 ml — — FDA listed —
CareOne Nighttime Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 41520-0712-34 American 237 ml — — Discontinued —
cold and flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 42507-0001-40 HyVee 355 ml — — FDA listed —
Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 42507-0401-40 HyVee 355 ml — — FDA listed —
NiteTime Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 49035-0044-12 EQUATE 355 ml — — FDA listed —
equate nighttime cold and flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 49035-0324-34 Wal-Mart 237 ml — — Discontinued —
equate nighttime cold and flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 49035-0609-40 Wal-Mart 355 ml — — FDA listed —
Night Time Cold and Flu ReadyInCase 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 49580-0343-02 P 355 ml — — FDA listed —
Nighttime Cold and Flu ReadyInCase 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 49580-0346-02 P 355 ml — — FDA listed —
Tukol Honey Nighttime Cold and Flu 21.667 mg/mL; 1 mg/mL; .4167 mg/mL 50066-0303-04 Genomma 1 bottle — — FDA listed —
Cold and Flu Nighttime Relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 50844-0252-02 L.N.K. 355 ml — — FDA listed —
Nighttime Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 51316-0343-08 CVS 237 ml — — FDA listed —
Nighttime Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 51316-0344-12 CVS 355 ml — — FDA listed —
CVS Nighttime Cold and Flu Relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 51316-0692-12 CVS 354 ml — — FDA listed —
Nighttime Cold And Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 51316-0884-40 CVS 355 ml — — FDA listed —
NIGHT-TIME MULTI-SYMPTOM COLD/FLU Original 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 53942-0501-28 DeMoulas 354 ml — — FDA listed —
NIGHT-TIME MULTI-SYMPTOM COLD/FLU Cherry 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 53942-0502-28 DeMoulas 354 ml — — FDA listed —
Original Night-Time MULTI-SYMPTOM COLD/FLU RELIEF 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 53943-0501-28 Discount 354 ml — — FDA listed —
Night-Time Multi-Symptom Cold/Flu Relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 53943-0502-28 Discount 354 ml — — FDA listed —
Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 55301-0310-02 ARMY 355 ml — — FDA listed —
Family Dollar Nighttime Cold and Flu Relief Original Flavor 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 55319-0692-12 FAMILY 354 ml — — FDA listed —
Family Dollar Nighttime Cold and Flu Relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 55319-0926-12 FAMILY 354 ml — — FDA listed —
Sanatos Nighttime Multi Symptoms 12.5 mg/30mL; 30 mg/30mL; 650 mg/30mL 55758-0056-25 Pharmadel 177 ml — — FDA listed —
Sanatos Multi Symptoms Nighttime 650 mg/30mL; 12.5 mg/30mL; 30 mg/30mL 55758-0416-06 Pharmadel 177 ml — — FDA listed —
dg health night time cold and flu relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 55910-0335-34 Dolgencorp 237 ml — — FDA listed —
Cold and Flu Nighttime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 55910-0443-12 Dolgencorp, 355 ml — — FDA listed —
dg health cold and flu relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 55910-0459-34 Dolgencorp 237 ml — — FDA listed —
Nitetime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 56062-0335-40 Publix 355 ml — — FDA listed —
nighttime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 56062-0459-40 Publix 355 ml — — FDA listed —
Nite-Time COLD/FLU ORIGINAL 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 57243-0501-25 Salado 177 ml — — FDA listed —
Nite-TimeCOLD/FLU CHERRY COLD/FLU CHERRY 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 57243-0502-25 Salado 177 ml — — FDA listed —
Nighttime Cold and Flu Relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 59779-0335-34 CVS 237 ml — — Discontinued —
nighttime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 59779-0459-34 CVS 237 ml — — Discontinued —
Cold and Flu Nighttime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 63868-0140-08 QUALITY 237 ml — — FDA listed —
Cold and Flu Nighttime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 63868-0234-08 QUALITY 237 ml — — FDA listed —
Cold and Flu Nighttime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 63941-0343-08 Best 237 ml — — FDA listed —
Cold and Flu Nighttime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 63941-0344-08 Best 237 ml — — FDA listed —
Circle K Nighttime Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 66715-5534-04 Lil' 237 ml — — FDA listed —
24-7 Life BY 7-ELEVEN Nighttime Cold and Flu 30 mg/30mL; 650 mg/30mL; 12.5 mg/30mL 66715-6416-04 Lil' 355 ml — — FDA listed —
Nighttime Relief, Cold and Flu, 24-7 Life by 7-Eleven 650 mg/30mL; 12.5 mg/30mL; 30 mg/30mL 66715-6616-04 Lil' 177 ml — — FDA listed —
Nighttime Cold and Flu Lil Drug Store Products 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 66715-6934-04 Lil' 237 ml — — FDA listed —
Cold and Flu Relief Multi Symptom Nighttime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 67091-0258-23 WinCo 237 ml — — FDA listed —
Cold and Flu Relief Multi Symptom Nighttime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 67091-0260-23 WinCo 237 ml — — FDA listed —
Nighttime Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 69256-0343-12 Harris 355 ml — — FDA listed —
Night Time Cold and Flu original 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 69256-0344-12 Harris 355 ml — — FDA listed —
Vicks NyQuil Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 69423-0789-08 The 236 ml — — FDA listed —
Vicks NyQuil Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 69423-0791-08 The 236 ml — — FDA listed —
Vicks NyQuil HIGH BLOOD PRESSURE Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 69423-0973-06 The 177 ml — — FDA listed —
Nighttime HBP Cold and Flu Relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 69842-0086-02 CVS 355 ml — — FDA listed —
Cold and Flu Nighttime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 70000-0673-01 Cardinal 355 ml — — FDA listed —
Cold and Flu Nighttime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 71141-0180-32 Lidl 355 ml — — FDA listed —
basic care nighttime cold and flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 72288-0335-34 Amazon.com 237 ml — — FDA listed —
basic care nighttime cold and flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 72288-0459-34 Amazon.com 237 ml — — FDA listed —
Nighttime Cold And Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 72288-0670-00 Amazon.com 237 ml — — FDA listed —
Nighttime Cold And Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 72288-0990-01 Amazon.com 355 ml — — FDA listed —
XL-3 Xtreme 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 76281-0305-28 AptaPharma 354 ml — — FDA listed —
XL-3 Xtreme 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 76281-0307-25 AptaPharma 177 ml — — FDA listed —
Nite-Time COLD/FLU Medicine 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 76281-0501-25 AptaPharma 177 ml — — FDA listed —
Nite-Time COLD/FLU Medicine Cherry 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 76281-0502-25 AptaPharma 177 ml — — FDA listed —
Meijer Nitetime Cold and Flu Relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 79481-6921-02 MEIJER 354 ml — — FDA listed —
Nighttime Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 79903-0173-08 WALMART 237 ml — — FDA listed —
Nighttime Cold and Flu Liquid Cherry 30 mg/30mL; 12.5 mg/30mL; 650 mg/30mL 81660-0555-01 Grimann, 30 ml — — FDA listed —
Nighttime Cold and Flu 30 mg/30mL; 12.5 mg/30mL; 650 mg/30mL 81660-0777-01 Grimann, 30 ml — — FDA listed —
AXIM Night Time - Liquid 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 82706-0012-01 VIVUNT 355 ml — — FDA listed —
AXIV Night Time - Liquid 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 82706-0023-01 VIVUNT 355 ml — — FDA listed —
Nighttime Cold and Flu Relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 83324-0158-12 QUALITY 355 ml — — FDA listed —
Nighttime Cold and Flu Relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 83324-0159-08 QUALITY 237 ml — — FDA listed —
Nighttime Cold and Flu Relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 83324-0163-12 QUALITY 355 ml — — FDA listed —
Nighttime Cold and Flu Relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 83324-0164-08 QUALITY 237 ml — — FDA listed —
Vicks NyQuil Cold and Flu Nighttime Relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 84126-0314-04 The 118 ml — — FDA listed —
Vicks NyQuil Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 84126-0342-04 The 118 ml — — FDA listed —
Revasol Nighttime Cold And Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 84379-0276-04 Rnv 118 ml — — FDA listed —
XL-3 Night Time 12.5 mg/30mL; 650 mg/30mL; 30 mg/30mL 84379-0444-06 Rnv 177 ml — — FDA listed —
foster and thrive nighttime cold and flu relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 85766-0177-24 Sportpharm 237 ml — — FDA listed —
Nighttime Cold and Flu 30 mg/30mL; 12.5 mg/30mL; 650 mg/30mL 85828-0750-01 Grocery 354 ml — — FDA listed —
equaline nighttime cold and flu relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 41163-0459-34 United 237 ml — — Discontinued —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2011
On the market since
Aug 2011
📍
2026
Currently FDA-listed
15 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerTopco Associates LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code36800
First marketedAug 2011
Product typeHuman Otc Drug
Portfolio408 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 32 words ▾

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

⏱️ Dosage and Administration 54 words ▾

Directions • take only as directed – see Overdose warning • only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

⚠️ Warnings ~2 min read ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug.

If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. • if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have • liver disease • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • trouble urinating due to an enlarged prostate gland • persistent or chronic cough as occurs with smoking, asthma, or emphysema • a sodium-restricted diet Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin When using this product • excitability may occur, especially in children • marked drowsiness may occur • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery • alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if • pain or cough gets worse or lasts more than 7 days • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📦 Storage and Handling 19 words ▾

Other information • each 30 mL contains: sodium 36 mg • store at 20-25 ° C (68-77 ° F)

🧪 Active Ingredient 17 words ▾

Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg

🧪 Inactive Ingredients 29 words ▾

Inactive ingredients alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

🎯 Purpose 7 words ▾

Purpose Pain reliever/fever reducer Cough suppressant Antihistamine

📄 Do Not Use 98 words ▾

Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. • if you have ever had an allergic reaction to this product or any of its ingredients

📄 Ask a Doctor Before Use If 57 words ▾

Ask a doctor before use if you have • liver disease • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • trouble urinating due to an enlarged prostate gland • persistent or chronic cough as occurs with smoking, asthma, or emphysema • a sodium-restricted diet

📄 Ask a Doctor or Pharmacist Before Use If 22 words ▾

Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin

📄 When Using This Product 39 words ▾

When using this product • excitability may occur, especially in children • marked drowsiness may occur • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery • alcohol, sedatives, and tranquilizers may increase drowsiness

📄 Stop Use and Ask a Doctor If 59 words ▾

Stop use and ask a doctor if • pain or cough gets worse or lasts more than 7 days • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 46 words ▾

Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📄 Questions or Comments 2 words ▾

Questions? 1-888-423-0139

📄 Package Label / Principal Display Panel 64 words ▾

Package/Label Principal Display Panel TopCare ® health COMPARE TO VICKS ® NYQUIL ® ACTIVE INGREDIENTS MULTI-SYMPTOM RELIEF Nite Time Cold & Flu Relief PAIN RELIEVER – FEVER REDUCER – ACETAMINOPHEN COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr ANTIHISTAMINE – DOXYLAMINE SUCCINATE • Headache, Fever, Sore Throat, Minor Aches & Pains • Sneezing, Runny Nose • Cough ALCOHOL 10% 12 FL OZ (355 mL) CHERRY FLAVOR topcare-nitetime-cold-&-flu-relief-container-image.jpg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Topco Associates LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 237 ml (36800-0459-34). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Topco Associates LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 36800-0458-06 · Topco 36800-0460-25 · Topco →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.