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(from DailyMed)

Nighttime Cold and Flu Multi Symptom Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate 325 mg; 15 mg; 6.25 mg Capsule, Liquid Filled, 10-count

by Shield Pharmaceuticals Corp · 1 BLISTER PACK in 1 CARTON (83059-0024-1) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
NDC 83059-0024-01
🏷️ FDA NDC (as labeled) 83059-0024-1 billing pads the package segment with a zero
OTC Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Aug 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 83059-0024-1
Product NDC 83059-0024
11-digit billing NDC 83059002401
RxCUI 1094549
UNII 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2
UPC 0611419406149
Application # M012
SPL Set ID bd12f7bd-1e9b-4ad4-b584-e8d1fa81c70c
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 Discontinued
FDA listing status Discontinued by firm (certified through Aug 2026)
Marketing start 2024-04-06
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Why two NDCs? The FDA registers this code as 83059-0024-1 — a 5-4-1 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 package segment → 83059-0024-01. 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

LabelerShield Pharmaceuticals Corp
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code83059
First marketedApr 2024
Product typeHuman Otc Drug
Portfolio103 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

📖 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?

This is an over-the-counter liquid-filled capsule taken by mouth that combines three active ingredients commonly used for nighttime cold and flu symptom relief. Acetaminophen is typically used to reduce fever and relieve pain and aches. Dextromethorphan is a cough suppressant commonly included in cold products to reduce coughing. Doxylamine succinate is an antihistamine that functions as a sleep aid, often added to nighttime formulas to help with rest during illness.

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.

🧪 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.

💲 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.
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
Night Time Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 00904-6996-44 Major 1 capsule $0.120 — Availability likely —
Good Neighbor Pharmacy Night Time 325 mg/1; 15 mg/1; 6.25 mg 46122-0245-62 Amerisource 2 capsules $0.120 — Availability likely —
NightTime Cold and Flu Multi Symptom 325 mg/1; 15 mg/1; 6.25 mg 70000-0516-01 CARDINAL 1 capsule $0.120 — Availability likely —
Nighttime Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 83324-0148-24 QUALITY 1 capsule $0.120 — Availability likely —
good sense night time 325 mg/1; 15 mg/1; 6.25 mg 00113-0056-51 L. 2 capsules $0.132 — Discontinued —
Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime 325 mg/1; 15 mg/1; 6.25 mg 00031-8744-10 Haleon 2 capsules — — FDA listed —
Nighttime Cold and Flu 15 mg/1; 6.25 mg/1; 325 mg 00363-0850-24 WALGREENS 12 capsules — — FDA listed —
Walgreens NightTime Cold and Flu 325 mg/1; 15 mg/1; 6.25 mg 00363-8999-24 WALGREEN 12 capsules — — FDA listed —
Nightime Cold And Flu 15 mg/1; 325 mg/1; 6.25 mg 11673-0976-24 TARGET 12 capsules — — FDA listed —
Multi-Symptom Cold And Flu Relief Nighttime 325 mg/1; 15 mg/1; 6.25 mg 11822-1987-00 RITE 12 capsules — — FDA listed —
Night Time Cold and Flu Relief Multi Symptom 325 mg/1; 15 mg/1; 6.25 mg 11822-3335-05 Rite 1 capsule — — FDA listed —
Night Time Cold and Flu Relief Multi Symptom 325 mg/1; 15 mg/1; 6.25 mg 11822-3392-00 Rite 1 capsule — — FDA listed —
Cold and Flu Relief Nighttime 325 mg/1; 15 mg/1; 6.25 mg 21130-0849-24 Safeway, 1 capsule — — FDA listed —
Nighttime Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 21130-0899-24 Safeway, 1 capsule — — FDA listed —
Nighttime cold and flu relief 6.25 mg/1; 325 mg/1; 15 mg 21130-0940-24 BETTER 12 capsules — — FDA listed —
Kroger Nighttime Cold and Flu Softgel 325 mg/1; 15 mg/1; 6.25 mg 30142-0086-48 The 12 capsules — — FDA listed —
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate 325 mg/1; 6.25 mg/1; 15 mg 35916-0154-01 Softgel 12 capsules — — FDA listed —
topcare nite time cold and flu 325 mg/1; 15 mg/1; 6.25 mg 36800-0143-62 Topco 2 capsules — — FDA listed —
night time 325 mg/1; 15 mg/1; 6.25 mg 37808-0056-62 H 2 capsules — — FDA listed —
Nightime 325 mg/1; 15 mg/1; 6.25 mg 37808-0095-16 H-E-B 8 capsules — — FDA listed —
Nighttime Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 37835-0522-24 Bi-Mart 24 capsules — — FDA listed —
Nighttime Cold and Flu Relief Multi Symptom 325 mg/1; 15 mg/1; 6.25 mg 41163-0849-24 United 1 capsule — — FDA listed —
Nighttime Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 41163-0899-24 United 1 capsule — — FDA listed —
Nighttime Cold And Flu 15 mg/1; 325 mg/1; 6.25 mg 41226-0694-24 Kroger 12 capsules — — FDA listed —
Cold and Flu 325 mg/1; 15 mg/1; 6.25 mg 42507-0056-62 HyVee 2 capsules — — FDA listed —
NiteTime Cold/Flu, Multi-Symptom Relief 325 mg/1; 15 mg/1; 6.25 mg 49035-0978-04 Wal-Mart 12 capsules — — FDA listed —
Tylenol Cold Plus Flu Multi-Symptom Gels Night 15 mg/1; 6.25 mg/1; 325 mg 50580-0131-24 Kenvue 12 capsules — — FDA listed —
Nighttime Cold and Flu 325 mg/1; 15 mg/1; 6.25 mg 53345-0006-01 Humanwell 4000 capsules — — FDA listed —
Nighttime Cold and Flu 325 mg/1; 15 mg/1; 6.25 mg 53345-0026-01 Humanwell 4000 capsules — — FDA listed —
Night Time Multi-Symptom Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 53943-0603-03 Discount 12 capsules — — FDA listed —
Nighttime Cold/Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 55301-0603-03 ARMY 12 capsules — — FDA listed —
Nighttime Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 55319-0968-08 Family 1 capsule — — FDA listed —
Sanatos Nighttime 325 mg/1; 15 mg/1; 6.25 mg 55758-0510-08 Pharmadel 8 capsules — — FDA listed —
Cold and Flu Relief Nighttime 325 mg/1; 15 mg/1; 6.25 mg 55910-0149-48 Dolgencorp, 1 capsule — — FDA listed —
DG Health Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 55910-0300-51 Dolgencorp 2 capsules — — Discontinued —
Cold and Flu Relief Nighttime 325 mg/1; 15 mg/1; 6.25 mg 55910-0599-48 Dolgencorp, 1 capsule — — FDA listed —
Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 55910-0910-08 Dolgencorp, 1 capsule — — FDA listed —
nitetime 325 mg/1; 15 mg/1; 6.25 mg 56062-0056-62 Publix 2 capsules — — FDA listed —
Nighttime Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 57243-0603-03 SALADO 12 capsules — — FDA listed —
Nighttime Cold And Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 58602-0769-15 Aurohealth 16 capsules — — FDA listed —
Kroger NightTime Cold and Flu SOFTGEL 325 mg/1; 15 mg/1; 6.25 mg 59450-0047-48 The 12 capsules — — FDA listed —
Night Time Cold and Flu Relief Multi Symptom 325 mg/1; 15 mg/1; 6.25 mg 59726-0899-08 P 1 capsule — — FDA listed —
Night Time Cold and Flu Relief Multi Symptom 325 mg/1; 15 mg/1; 6.25 mg 63868-0418-24 QUALITY 1 capsule — — FDA listed —
Night Time Cold and Flu Multi Symptom 325 mg/1; 15 mg/1; 6.25 mg 63868-0737-24 QUALITY 1 capsule — — FDA listed —
Circle K Nighttime Cold and Flu 325 mg/1; 15 mg/1; 6.25 mg 66715-5572-08 Lil' 2 capsules — — FDA listed —
Nighttime Cold and Flu 325 mg/1; 15 mg/1; 6.25 mg 66715-6716-08 Lil' 2 capsules — — FDA listed —
Nighttime Cold and Flu 325 mg/1; 15 mg/1; 6.25 mg 66715-6816-08 Lil' 2 capsules — — FDA listed —
Night Time Cold and Flu Relief Multi Symptom 325 mg/1; 15 mg/1; 6.25 mg 67091-0338-24 WinCo 1 capsule — — FDA listed —
NightTime Cold and Flu Multi Symptom 325 mg/1; 15 mg/1; 6.25 mg 67091-0395-24 WinCo 1 capsule — — FDA listed —
Nighttime Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 68016-0798-16 Chain 1 capsule — — Discontinued —
Nighttime Cold And Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 68016-0878-16 Chain 16 capsules — — FDA listed —
DRX CHOICE NIGHTTIME COLD and FLU RELIEF 325 mg/1; 15 mg/1; 6.25 mg 68163-0062-10 Raritan 2 capsules — — FDA listed —
Nighttime Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 69168-0418-29 Allegiant 8 capsules — — FDA listed —
Nighttime Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 69256-0899-24 Harris 1 capsule — — FDA listed —
Vicks NyQuil COLD and FLU 15 mg/1; 6.25 mg/1; 325 mg 69423-0995-02 The 2 capsules — — FDA listed —
Night-Time Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 69517-0161-10 HealthLife 10 capsules — — FDA listed —
Ampigrin Ultra Forte Night 15 mg/1; 6.25 mg/1; 325 mg 69729-0003-10 OPMX 10 capsules — — FDA listed —
Pentrexcilina Night Time 15 mg/1; 6.25 mg/1; 325 mg 69729-0041-10 OPMX 10 capsules — — FDA listed —
Nitecin 15 mg/1; 6.25 mg/1; 325 mg 69729-0054-10 OPMX 10 capsules — — FDA listed —
Viro Flu PM Relief 15 mg/1; 6.25 mg/1; 325 mg 69729-0057-10 OPMX 10 capsules — — FDA listed —
tabcin NIGHT 15 mg/1; 6.25 mg/1; 325 mg 69729-0153-10 OPMX 10 capsules — — FDA listed —
Night Time Cold and Flu Relief Multi Symptom 325 mg/1; 15 mg/1; 6.25 mg 69842-0847-16 CVS 1 capsule — — FDA listed —
Night Time Cold and Flu Relief Multi Symptom 325 mg/1; 15 mg/1; 6.25 mg 69842-0899-16 CVS 1 capsule — — FDA listed —
Contac Cold And Flu 325 mg/1; 15 mg/1; 6.25 mg 71179-0003-08 VESPYR 8 capsules — — FDA listed —
Nighttime Cold and Flu 325 mg/1; 15 mg/1; 6.25 mg 71679-0102-00 Health 1500 capsules — — FDA listed —
basic care nighttime cold and flu 325 mg/1; 15 mg/1; 6.25 mg 72288-0056-62 Amazon.com 2 capsules — — FDA listed —
Nighttime Cold and Flu 325 mg/1; 15 mg/1; 6.25 mg 72476-0899-24 Care 1 capsule — — FDA listed —
Nite Time Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 76162-0026-16 TopCo 8 capsules — — FDA listed —
NightTime Cold and Flu 325 mg/1; 15 mg/1; 6.25 mg 76168-0056-02 Velocity 1 capsule — — FDA listed —
Night Time Cold and Flu relief liquid filled softgels 325 mg/1; 15 mg/1; 6.25 mg 76281-0603-03 AptaPharma 12 capsules — — FDA listed —
meijer Nighttime Cold and Flu SOFTGEL 325 mg/1; 15 mg/1; 6.25 mg 79481-0808-04 Meijer, 12 capsules — — FDA listed —
meijer Nighttime Cold and Flu SOFTGEL 325 mg/1; 15 mg/1; 6.25 mg 79481-0828-04 Meijer, 12 capsules — — FDA listed —
Nighttime Cold And Flu Relief Softgels Multi-Symptom 15 mg/1; 6.25 mg/1; 325 mg 80513-0302-50 Advanced 50 capsules — — FDA listed —
Nighttime Cold And Flu Relief 15 mg/1; 6.25 mg/1; 325 mg 80513-0304-50 Advanced 50 capsules — — FDA listed —
Multi-Symptom Nighttime Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 80513-0316-50 Advanced 50 capsules — — FDA listed —
Night Time Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 81522-0899-16 FSA 1 capsule — — FDA listed —
AXIV NightTime 325 mg/1; 15 mg/1; 6.25 mg 82706-0016-01 VIVUNT 8 capsules — — FDA listed —
Nighttime Cold and Flu Multi Symptom Relief 325 mg/1; 15 mg/1; 6.25 mgthis 83059-0024-01 Shield 10 capsules — — Discontinued —
Nighttime Cold and Flu Multi Symptom Relief 325 mg/1; 15 mg/1; 6.25 mg 83059-0112-01 Shield 10 capsules — — Discontinued —
Nuvicare NightTime Cold and Flu Softgel 325 mg/1; 15 mg/1; 6.25 mg 84324-0019-01 NUVICARE 10 capsules — — FDA listed —
Nuvicare NightTime Cold and Flu Softgel 325 mg/1; 15 mg/1; 6.25 mg 84324-0024-01 NUVICARE 10 capsules — — FDA listed —
Dr. Simi Nighttime Cold and Flu 15 mg/1; 6.25 mg/1; 325 mg 85786-0602-24 Farmacias 12 capsules — — FDA listed —
Nighttime Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 85828-0418-93 Grocery 24 capsules — — FDA listed —
Nighttime Cold and Flu Multi Symptom Relief 325 mg/1; 15 mg/1; 6.25 mg 83059-0177-01 Shield 10 capsules — — 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

🏛️
2024
On the market since
Apr 2024
📍
2026
Currently FDA-listed
2 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.

🔬 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 Nighttime Cold and Flu Multi Symptom Relief (this brand).

Top reported reactions

Contusion1
Dehydration1
Drug Toxicity1
Hepatic Necrosis1
Hepatic Steatosis1

Reporter sex

0 reports
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
83059-0024-01 You're viewing this 1 BLISTER PACK in 1 CARTON (83059-0024-1) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2024-04-06 Discontinued by firm

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 83059-0024-1, 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: 83059-0024-01, written without dashes as 83059002401. 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 83059-0024-01, the first segment (83059) is the labeler code FDA assigned to Shield Pharmaceuticals Corp; the middle segment (0024) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Shield Pharmaceuticals Corp 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 29 words ▾

Uses temporarily relieves common cold/flu symptoms: • cough due to minor throat & bronchial irritation • sore throat • headache• minor aches & pains• fever• runny nose & sneezing

⏱️ Dosage and Administration 48 words ▾

Directions • take only as directed • do not exceed 8 softgels per 24 hrs • adults & children 12 yrs & over 2 Softgels with water every 6 hrs • children 4 to under 12 yrs ask a doctor • children under 4 yrs do not use

⚠️ Warnings 109 words ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 8 Softgels in 24 hrs, which is the maximum daily amount for this product • with other drugs containing acetaminophen • 3 or more alcoholic drinks daily 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.

🧪 Active Ingredient 16 words ▾

Active ingredient (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg

🧪 Inactive Ingredients 22 words ▾

Inactive ingredients butylated hydroxyanisole, FD&C Blue No. 1, gelatin, glycerin, methyl paraben, polyethylene glycol-400, propylene glycol, propyl Paraben, povidone, purified water, sorbitol

🎯 Purpose 7 words ▾

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 ↗
← 83059-0023-01 · Shield 83059-0026-08 · Shield →
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.