ED A-HIST DM DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE HYDROCHLORIDE 15 mg/5mL; 4 mg/5mL; 10 mg/5mL Liquid, 473 mL — NDC 00485-0171-16 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ED A-HIST DM DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE HYDROCHLORIDE 15 mg/5mL; 4 mg/5mL; 10 mg/5mL Liquid, 473 mL — NDC 0485-0171-16 (Billing 00485-0171-16)

by EDWARDS PHARMACEUTICALS, INC. · 473 mL in 1 BOTTLE, PLASTIC

This is a package of 473 mL of ED A-HIST DM DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE HYDROCHLORIDE 15 mg/5mL; 4 mg/5mL; 10 mg/5mL Liquid from EDWARDS PHARMACEUTICALS, INC., marketed since Sep 2012 and currently FDA-listed; retail pharmacies pay about $0.0669 per mL (NADAC). It is this product's only package size.

NDC 00485-0171-16
🏷️ FDA NDC (as labeled) 0485-0171-16 billing pads the labeler segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0485-0171-16
Product NDC 0485-0171
11-digit billing NDC 00485017116
NCPDP billing unit ML — per mL (volume)
RxCUI 1086443
UNII 9D2RTI9KYH, V1Q0O9OJ9Z, 04JA59TNSJ
UPC 0304850171164
Application # M012
SPL Set ID e0e2b117-62bc-4132-9f7c-fe2a912052b1
Established class (EPC) Histamine-1 Receptor Antagonist; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; Uncompetitive NMDA Rece
Mechanism of action Adrenergic alpha1-Agonists; Histamine H1 Receptor Antagonists; Sigma-1 Receptor Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-09-11
Route ORAL
Dosage form LIQUID
Substance DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 43995803120930
GPI class Ed-A-Hist DM
GCN Seq No 051896
GCN 19347
HICL code 000375
Ingredient (HICL) Chlorpheniramine/Phenyleph/Dm
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B3
Therapeutic class — intermediate (HIC2) Drugs Affecting Primarily The Trachea And Bronchi
HIC3 code B3R
Therapeutic class — specific (HIC3) Non-Opioid Antitus-1St Gen.antihistamine-Decongest
AHFS code 04:04.00.00
AHFS class First Generation Antihistamines
FDB label name ED-A-HIST DM LIQUID
FDB brand name Ed-A-Hist Dm
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 051896
  • GCN: 19347
  • GPI-14 (Medi-Span): 43995803120930
  • HICL (First Databank): 000375
  • AHFS class code: 04:04.00.00
  • RxCUI (RxNorm): 1086443
Why two NDCs? The FDA registers this code as 0485-0171-16 — a 4-4-2 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 labeler segment → 00485-0171-16. 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 Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Substituted alkylamines
How it works Histamine H1 Receptor Antagonists
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

Label name ED-A-HIST DM LIQUID Ingredient Chlorpheniramine/Phenyleph/Dm
📖 About the active ingredient MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Chlorpheniramine is used to treat allergy symptoms: sneezing runny nose itchy nose or throat red, itchy, watery eyes Chlorpheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Read the full MedlinePlus article ↗
🧪 What is this product?

ED A-Hist DM is an over-the-counter liquid product taken by mouth that combines three active ingredients commonly used to manage cold and allergy symptoms. Dextromethorphan is typically used to reduce cough, while chlorpheniramine is an antihistamine commonly used to help relieve allergy symptoms such as sneezing and itching. Phenylephrine is a decongestant typically used to help relieve nasal congestion. This product is marketed under FDA's over-the-counter drug monograph rules for cough and cold products.

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 $0.067 $31.64 / 473 ml
Medicaid paysCMS SDUD · 12 mo $0.0672 $31.79 / 473 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Sep 2022 Feb 2026 Sep 2026 $0.068 $0.057
▲ Up 6% over the last 20 months.
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
00485-0171-16 You're viewing this Main listing 473 mL in 1 BOTTLE, PLASTIC 2012-09-11 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ed A-Hist Dm 15 mg/5mL; 4 mg/5mL; 10 mg/5mLthis 00485-0171-16 EDWARDS 473 ml $0.067 — Availability likely —
NoHist DM 4 mg/5mL; 10 mg/5mL; 15 mg/5mL 68047-0186-16 Larken 473 ml $0.067 — Availability likely —
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

🏛️
2012
On the market since
Sep 2012
📍
2026
Currently FDA-listed
14 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.

What it looks like

Color yellow
FlavorBanana
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • 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 A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • 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 Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • 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 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • 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.

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

The official label also statesArtificial and Natural Banana Flavor, Citric Acid, FD&C Red #40, FD&C Yellow #6, Methyl Paraben, Propyl Paraben, Propylene Glycol, Purified Water, Sodium Citrate, Sucralose.

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.

Manufacturer & labeler

LabelerEDWARDS PHARMACEUTICALS, INC.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code00485
First marketedSep 2012
Product typeHuman Otc Drug
Portfolio11 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 45 words ▾

Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes cough due to minor throat and bronchial irritation nasal congestion reduces swelling of nasal passages

⏱️ Dosage and Administration 74 words ▾

Directions Do not exceed recommended dosage Adults and children 12 years of age and over: 1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: 1/2 teaspoonful (2.5 mL) every 4 hours, not to exceed 3 teaspoonfuls in 24 hours, or as directed by a doctor. Children under 6 years of age: Consult a doctor.

⚠️ Warnings ~1 min read ▾

Warnings Do not exceed recommended dosage. Do not use this product 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.

Do not use this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis glaucoma a persistent or chronic cough that occurs with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes mellitus difficulty in urination due to enlargement of the prostate gland Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. When using this product excitability may occur, especially in children may cause marked drowsiness sedatives and tranquilizers may increase drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery Stop use and ask doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache.

These could be signs of a serious condition. new symptoms occur If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

📦 Storage and Handling 18 words ▾

Other information Store at 59° - 86° F (15° - 30° C) [see USP for Controlled Room Temperature].

🧪 Active Ingredient 24 words ▾

Active Ingredients (in each 5 mL teaspoonful) Purpose Chlorpheniramine Maleate 4 mg Antihistamine Dextromethorphan HBr 15 mg Antitussive Phenylephrine HCl 10 mg Nasal Decongestant

🧪 Inactive Ingredients 26 words ▾

Inactive ingredients Artificial and Natural Banana Flavor, Citric Acid, FD&C Red #40, FD&C Yellow #6, Methyl Paraben, Propyl Paraben, Propylene Glycol, Purified Water, Sodium Citrate, Sucralose.

🎯 Purpose 24 words ▾

Active Ingredients (in each 5 mL teaspoonful) Purpose Chlorpheniramine Maleate 4 mg Antihistamine Dextromethorphan HBr 15 mg Antitussive Phenylephrine HCl 10 mg Nasal Decongestant

📄 Do Not Use 128 words ▾

Do not use this product 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. Do not use this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis glaucoma a persistent or chronic cough that occurs with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes mellitus difficulty in urination due to enlargement of the prostate gland Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

📄 When Using This Product 34 words ▾

When using this product excitability may occur, especially in children may cause marked drowsiness sedatives and tranquilizers may increase drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery

📄 Stop Use and Ask a Doctor If 45 words ▾

Stop use and ask doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition. new symptoms occur

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breastfeeding, ask a health professional before use.

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

📄 Questions or Comments 4 words ▾

Question? Comments? Call 1-800-543-9560

📄 Package Label / Principal Display Panel 76 words ▾

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label E NDC 0485-0171-16 ED A-HIST DM Antihistamine • Antitussive • Nasal Decongestant Sugar Free • Gluten Free Each teaspoonful (5 mL) for oral administration contains: Chlorpheniramine Maleate 4 mg Dextromethorphan HBr 15 mg Phenylephrine HCl 10 mg Banana Flavor Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. Manufactured for: EDWARDS Pharmaceuticals, Inc.

Ripley, MS 38663 16oz. (473 mL) EdHist0171

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
10.6K
Units reimbursed last 4 qtrs
1M
Gross reimbursed last 4 qtrs
$68.9K
Avg / prescription
$6.51
Avg / unit
$0.0672
Latest quarter Q1 2026
2.5KRx
Medicaid pays / mL
$0.0672
gross reimbursed
vs
NADAC / mL
$0.0669
acquisition cost
=
Spread
+$0.0003
+0% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 10,588 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 2,626 units · 124 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 1,023,100 units · 9,276 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
1249,276
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Georgia 9,276 /100k
2 New Mexico 124 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
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.