NiteTime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL Liquid, 355 mL — NDC 49035-044-12 (Billing 49035-0044-12)
by EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) · 355 mL in 1 BOTTLE, PLASTIC
This is a package of 355 mL of NiteTime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL Liquid from EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC), marketed since Dec 2014 and currently FDA-listed, this package's marketing is listed to end Jul 2027. It is the main listing for this product, which comes in 2 package sizes.
NDC 49035-0044-12
🏷️ FDA NDC (as labeled)
49035-044-12
billing pads the product segment with a zero
This package
Contains355 mL
Pack sizes2 compare ↓
Main listing for product 49035-044 · Also comes in:
2 bottles 49035-044-24
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
NDC database record
One package, one record: these facts belong to NDC 49035-044-12 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 49035 labeler · 044 product · 12 package
- Package marketed since
- Dec 31, 2014
- Package marketing ended
- Jul 28, 2027
- Sample package
- No — commercial package
- Barcode (UPC-A, from the NDC)
- 3 4903504412 3
- FDA record last changed
- Oct 8, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
49035-044-12
Product NDC
49035-044
11-digit billing NDC
49035004412
Application #
M012
SPL Set ID
742f2d49-197c-49bd-9675-d503b77811c8
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
2014-12-31
Marketing end
2027-07-28
Route
ORAL
Dosage form
LIQUID
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Why two NDCs?
The FDA registers this code as 49035-044-12 — 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 → 49035-0044-12. 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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
Clinical
📖 About the active ingredient MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.
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 ↗🧪 What is this product?
NiteTime Cold and Flu is an over-the-counter liquid medication taken by mouth that contains three active ingredients commonly used to manage cold and flu symptoms. Acetaminophen is a pain reliever and fever reducer. Dextromethorphan is a cough suppressant. Doxylamine succinate is a sedating antihistamine typically used to help with sleep and reduce runny nose or sneezing. This product is a monograph drug, meaning it follows FDA's established rules for over-the-counter cold and flu medicines.
Patient education
Supplement & herbal interactions
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
💬 Questions about Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per mL | Per 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:
2 bottles
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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 8, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 49035-0044-12 You're viewing this Main listing | 355 mL in 1 BOTTLE, PLASTIC | 2014-12-31 | Jul 28, 2027 | Active |
| 49035-0044-24 49035-044-24 | 2 BOTTLE, PLASTIC in 1 PACKAGE / 355 mL in 1 BOTTLE, PLASTIC | 2014-12-31 | Jul 28, 2027 | Active |
Pack size FAQ
What quantity is in this package?
This package contains 355 mL — 355 ml in 1 bottle, plastic.
What NDC number is used to bill for this package of NiteTime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL Liquid?
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
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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2014
On the market since
Dec 2014
📍
2026
Currently FDA-listed
12 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.
- FDA Orange Book · refreshed Oct 3, 2026
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.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
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
LabelerEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code49035
First marketedDec 2014
Product typeHuman Otc Drug
Portfolio41 products on file
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- Equate nicotine Nicotine Polacrilex 2 mg Gum, Chewing NDC 49035-029-29
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- Mineral oil 100 mg/100mL Oil NDC 49035-035-16
- Petroleum Skin Protectant White Petrolatum 1 g/g Jelly NDC 49035-038-10
- Witch Hazel 842 mg/mL Liquid NDC 49035-039-16
- equate pain and fever childrens Acetaminophen 160 mg/5mL Suspension NDC 49035-042-26
- Cherry Antacid Soft Chews calcium carbonate 1177 mg Tablet, Chewable NDC 49035-046-32
- Assorted Fruit Antacid Flavor Chews Calcium Carbonate 750 mg Tablet, Chewable NDC 49035-048-20
- First Aid Antiseptic POVIDONE-IODINE 10 mg/mL Solution NDC 49035-050-34
- Cold and Flu severe Acetaminophen,Dextromethorphan HBr,Guaifenesin,Phenylephrine HCl 325 mg; 10 mg; 200 mg; 5 mg Tablet, Film Coated NDC 49035-053-08
- Mixed Berry Antacid and Anti-Gas Chews Calcium Carbonate 80 mg; 750 mg Tablet, Chewable NDC 49035-058-54
- EQUATE Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate 400 [iU]/g; 3.5 mg/g; 5000 [iU]/g Ointment NDC 49035-067-16
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 openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
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.
📄 FDA label ▾
No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.
No label section mentions that — try another word, or open the full label on DailyMed below.
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 it is currently marketed — but EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) has reported a marketing end date of 2027-07-28, after which this package is expected to stop being marketed. 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 2 bottles (49035-0044-24). 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?
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART 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.
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.