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Nite-Time COLD/FLU Medicine ACETAMINOPHEN 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL Liquid, 177 mL — NDC 76281-0501-25 package photo

Nite-Time COLD/FLU Medicine ACETAMINOPHEN 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL Liquid, 177 mL

by AptaPharma Inc. · 177 mL in 1 BOTTLE (76281-501-25)
NDC 76281-0501-25
🏷️ FDA NDC (as labeled) 76281-501-25 billing pads the product segment with a zero
This package
Contains177 mL Pack sizes2 compare ↓
Also comes in: 354 ml 76281-0501-28
OTC On market Non-controlled
🗂️ Data synced 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

⚠️
Other active recalls for Acetaminophen (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 21, 2025 — Defective Container (Kenvue Brands LLC) · FDA recall D-0121-2026
Class II · Aug 20, 2025 — Discoloration (Baxter Healthcare Corporation) · FDA recall D-0596-2025
Class II · May 22, 2025 — cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets). (Aurobindo Pharma USA Inc) · FDA recall D-0471-2025
Class I · Jul 8, 2024 — Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) (Hikma Pharmaceuticals USA Inc.) · FDA recall D-0635-2024
Class II · May 20, 2024 — Discoloration: Brownish tablets (Contract Pharmacal Corporation) · FDA recall D-0566-2024
Class II · Nov 13, 2023 — Failed Impurities/Degradation Specifications (KINDER FARMS LLC) · FDA recall D-0143-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 76281-501-25
Product NDC 76281-501
11-digit billing NDC 76281050125
RxCUI 1043400
UNII 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2
Application # M012
SPL Set ID 344440bc-d810-4296-93ec-e6ae6673856b
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 2018-03-09
Route ORAL
Dosage form LIQUID
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Why two NDCs? The FDA registers this code as 76281-501-25 — 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 → 76281-0501-25. 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.

🏭 Manufacturer & labeler

LabelerAptaPharma Inc.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code76281
First marketedMar 2018
Product typeHuman Otc Drug
Portfolio29 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.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Acetaminophen is used to relieve mild to moderate pain and to reduce fever. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Acetaminophen is a pain reliever and fever reducer. You can use it for everyday aches like headaches, backaches, sore muscles, toothaches, minor arthritis pain, cold-related discom...
  • What is acetaminophen actually used for?
  • That's a smart thing to think about. The biggest danger with acetaminophen is taking more than the maximum daily dose allowed on your product label — especially if you're also taki...
  • How much is too much? I'm worried about taking it too often.
📖 Read our full Acetaminophen guide →
1
Nutrient depletion considerations

Acetaminophen may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Acetaminophen nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII 3P3ONR6O1S
    A synthetic green dye approved by the FDA for use in medicines and foods. It serves as a colorant to make the pill or liquid visually distinctive and help with product identification.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

12 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesInactive ingredients: citric acid, D and C yellow No. 10, FD and C Green No. 3, FD and C Yellow No. 6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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.

💲 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: 354 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.

🔁 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/30mL 36800-0459-34 Topco 237 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/30mLthis 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 —
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

🏛️
2018
On the market since
Mar 2018
📍
2026
Currently FDA-listed
8 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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Acetaminophen (matched by generic name) — the program that covers self-administered drugs. 5 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Acetaminophen. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$34K
Claims incl. refills
277
Beneficiaries
145
Spend / beneficiary
$234.25
Spend / claim
$122.62
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Nite-Time COLD/FLU Medicine (this brand).

Top reported reactions

Fatigue20,901
Pain18,469
Nausea18,167
Headache17,127
Toxicity To Various Agents15,843
Dyspnoea15,012
Pyrexia14,579

Age at onset

Neonate562
Infant376
Child2,615
Adolescent2,132
Adult26,646
Elderly17,765

Reporter sex

253,624 reports
Male · 38%
Female · 62%
Unknown · 0%

Serious outcomes

Hospitalization114,315
Death49,977
Life-threatening21,902
Disabling12,025
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 28,614 12,589
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
76281-0501-25 You're viewing this 177 mL in 1 BOTTLE (76281-501-25) 2018-03-09 Active
76281-0501-28 354 mL in 1 BOTTLE (76281-501-28) 2018-03-09 Active

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

Pack size FAQ

What quantity is in NDC 76281-0501-25?
NDC 76281-0501-25 contains 177 mL — 177 ml in 1 bottle.
What is the difference between NDC 76281-0501-25 and NDC 76281-0501-28?
Both are Nite-Time COLD/FLU Medicine ACETAMINOPHEN 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL Liquid — the drug itself is identical. NDC 76281-0501-25 is the 177 mL package, while NDC 76281-0501-28 is the 354 ml package.
What NDC number is used to bill for this package of Nite-Time COLD/FLU Medicine ACETAMINOPHEN 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL Liquid?
Bill NDC 76281-0501-25 — the 11-digit billing format is 76281050125. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 ✓ Available
Inactive ingredients (structured) ✓ 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 FDA registers it as 76281-501-25, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 76281-0501-25, written without dashes as 76281050125. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 76281-0501-25, the first segment (76281) is the labeler code FDA assigned to AptaPharma Inc.; the middle segment (0501) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (25) identifies this exact package size and type. Together they name one specific package of one specific product.
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 AptaPharma Inc.. 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 354 ml (76281-0501-28). 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?
AptaPharma Inc. 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.

📄 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 🆘 Overdosage 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 27 words ▾

Uses Uses temporarily relieves cold/flu symptoms: sore throat minor aches and pain runny nose and sneezing cough due to minor sore throat and bronchial irritation headache fever

⏱️ Dosage and Administration 71 words ▾

Directions Directions take only as recommended-see Overdose warnings Use dose cup or tablespoon (TBSP) do not exceed 4 doses per 24 hours adults and children 12 years and over 30 mL (2TBSP) every 6 hours children 4 to under 12 years ask a doctor children under 4 years do not use If taking Nite Time at night and Day Time during the day, limit total to 4 doses per 24 hours

⚠️ Warnings 81 words ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ● more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product ● with other drugs containing acetaminophen ● 3 or more alcoholic drinks everyday while using this product. 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.

🆘 Overdosage 52 words ▾

Overdose Warning Overdose warning: Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

🧪 Active Ingredient 23 words ▾

Active Ingredients Drug Facts Active ingredients (in each 30 mL dose cup) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine Succinate 12.5 mg

🧪 Inactive Ingredients 39 words ▾

Inactive Ingredients Inactive ingredients: citric acid, D and C yellow No. 10, FD and C Green No. 3, FD and C Yellow No. 6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

🎯 Purpose 8 words ▾

Purpose Purpose Pain reliever/fever reducer Cough suppressant Antihistamine

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 76281-0307-25 · AptaPharma 76281-0502-25 · AptaPharma →
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.