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Mielim y mas Dextromethorphan 15 mg/5mL Liquid, 118 mL — NDC 58593-0295-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Mielim y mas Dextromethorphan 15 mg/5mL Liquid, 118 mL — NDC 58593-295-04 (Billing 58593-0295-04) · Product 58593-295

by Efficient Laboratories Inc. · 118 mL in 1 BOTTLE (58593-295-04)

NDC 58593-295-04 (billing 58593-0295-04) is a package of 118 mL of Mielim y mas Dextromethorphan 15 mg/5mL Liquid from Efficient Laboratories Inc., no longer marketed (first marketed Feb 1997), no longer in the FDA NDC Directory. It is the main listing for product NDC 58593-295, which comes in 2 package sizes.

NDC 58593-0295-04
🏷️ FDA NDC (as labeled) 58593-295-04 billing pads the product segment with a zero
This package
Contains118 mL Pack sizes2 compare ↓
Main listing for product 58593-295 · Also comes in: 178 ml 58593-295-06
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58593-295-04
Product NDC 58593-295
11-digit billing NDC 58593029504
RxCUI 1090496, 1099285
UNII 9D2RTI9KYH
Application # M012
SPL Set ID 711d1dae-3af4-46af-a3a8-cd827356a81a
Established class (EPC) Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of action 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
Marketing start 1997-02-01
Route ORAL
Dosage form LIQUID
Substance DEXTROMETHORPHAN HYDROBROMIDE
Quick answers for NDC 58593-295-04
  • RxCUI (RxNorm): 1090496
  • 11-digit billing NDC: 58593029504
Why two NDCs? The FDA registers this code as 58593-295-04 — 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 → 58593-0295-04. 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 Uncompetitive N-methyl-D-aspartate Receptor Antagonist class.

Pharmacologic class Uncompetitive N-methyl-D-aspartate Receptor Antagonist, Sigma-1 Agonist
Drug family (ATC) Other antidepressants, Opium alkaloids and derivatives
How it works Uncompetitive NMDA Receptor Antagonists, Sigma-1 Receptor Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 What it is MedlinePlus · NLM

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's a cough suppressant. It temporarily relieves cough from minor throat and bronchial irritation, like with a cold or inhaled irritants. Some products also help you sleep by calm...
  • It depends on the product. Extended-release suspensions like Delsym are labeled for every 12 hours, while Giltuss Honey DM Cough is every 6 to 8 hours with a 4-dose daily limit. Ch...
  • Be careful. Don't use it if you take a prescription MAOI, or within 2 weeks of stopping one. If you're not sure whether your medicine is an MAOI, ask me or your doctor before takin...
  • Nighttime products can cause marked drowsiness, and children may become excitable. Avoid alcohol and be careful driving.
📖 Read our full Dextromethorphan guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 178 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
58593-0295-04 58593-295-04 You're viewing this Main listing 118 mL in 1 BOTTLE (58593-295-04) 1997-02-01 — Discontinued by firm
58593-0295-06 58593-295-06 178 mL in 1 BOTTLE (58593-295-06) 1997-02-01 — Active

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

Pack size FAQ

What quantity is in NDC 58593-0295-04?
NDC 58593-0295-04 contains 118 mL — 118 ml in 1 bottle.
What is the difference between NDC 58593-0295-04 and NDC 58593-0295-06?
Both are Mielim y mas Dextromethorphan 15 mg/5mL Liquid — the drug itself is identical. NDC 58593-0295-04 is the 118 mL package, while NDC 58593-0295-06 is the 178 ml package.
What NDC number is used to bill for this package of Mielim y mas Dextromethorphan 15 mg/5mL Liquid?
Bill NDC 58593-0295-04 — the 11-digit billing format is 58593029504. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Neighbor Long Acting Cough Adult Tussin 30 mg/10mL 46122-0784-29 AMERISOURCE 1 bottle $0.023 — Availability likely —
Adult Cough Relief 15 mg/5mL 83324-0134-04 QUALITY 1 bottle $0.023 — Availability likely —
Cough Relief Adult 15 mg/5mL 36800-0509-04 TOP 1 bottle — — FDA listed —
Tussin Long Acting Cough READYINCASE 30 mg/10mL 49580-0383-04 P 1 bottle — — Discontinued —
Cough Relief Adult 15 mg/5mL 55910-0309-04 Dolgencorp, 1 bottle — — FDA listed —
Giltuss Honey DM Cough 30 mg/10mL 58552-0143-04 Gil 1 bottle — — FDA listed —
Childrens Giltuss Honey DM Cough 15 mg/5mL 58552-0144-04 Gil 1 bottle — — FDA listed —
Giltuss Diabetic Dm 30 mg/10mL 58552-0149-04 Gil 1 bottle — — FDA listed —
Giltuss DM 30 mg/10mL 58552-0150-04 Gil 1 bottle — — FDA listed —
Mielim y mas 15 mg/5mLthis 58593-0295-04 Efficient 118 ml — — Discontinued —
Cough Relief Cough Suppressant 15 mg/5mL 63868-0957-04 QUALITY 1 bottle — — FDA listed —
Cough Relief 15 mg/5mL 63941-0309-04 Best 1 bottle — — FDA listed —
Cough Relief 15 mg/5mL 63941-0455-04 Best 1 bottle — — FDA listed —
Giltuss Honey DM Cough 30 mg/10mL 65852-0004-04 Dextrum 1 bottle — — FDA listed —
Childrens Giltuss Honey DM Cough 15 mg/5mL 65852-0007-04 Dextrum 1 bottle — — FDA listed —
Premier Value Tussin Cough Long Acting 30 mg/10mL 68016-0742-04 Chain 1 bottle — — FDA listed —
DRx Choice Long Acting Cough 30 mg/10mL 68163-0742-04 RARITAN 1 bottle — — FDA listed —
CVS Long Acting Cough 30 mg/10mL 69842-0634-04 CVS 1 bottle — — 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

🏛️
1997
On the market since
Feb 1997
📍
2026
Currently FDA-listed
29 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

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

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

Inactive Ingredients / Excipients

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

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

  • UNII Z0H242BBR1
    Aspartame is an artificial sweetener made from amino acids. It's added to medicines to improve taste, making bitter or unpleasant-tasting drugs easier to take.
  • UNII Y9H1V576FH
    Honey is a natural sweetener made by bees from flower nectar. In medicines, it adds sweetness to improve taste and may help soothe throat irritation in lozenges or syrups.
  • 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 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • 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 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • 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.

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

The official label also statesInactive Ingredients: Aspartame, Flavor, Honey, Methylparaben, Potassium Sorbate, Propylene Glycol, Propylparaben, Purified Water and Sodium Chloride.

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

LabelerEfficient Laboratories Inc.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code58593
First marketedFeb 1997
Product typeHuman Otc Drug
Portfolio5 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 13 words ▾

Temporarily relieves cough as may occur with the common cold or inhaled irritants.

⏱️ Dosage and Administration 61 words ▾

Directions: Shake well immediately before use. Do not exceed 4 doses in any 24 hour period. Adults and Children 12 years and over - 10 ml (2 tsps) every 6 to 8 hours Children 6 to under 12 years of age - 5 ml (1 tsp) every 6 to 8 hours Children under 6 years of age - Consult a doctor

⚠️ Warnings 35 words ▾

Warnings A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache, consult a doctor.

🧪 Active Ingredient 14 words ▾

Active Ingredient: (In each teaspoonful 5 mls) Purpose Dextromethorphan HBr 15 mg (USP)................................................Cough Suppressant

🧪 Inactive Ingredients 16 words ▾

Inactive Ingredients: Aspartame, Flavor, Honey, Methylparaben, Potassium Sorbate, Propylene Glycol, Propylparaben, Purified Water and Sodium Chloride.

🎯 Purpose 2 words ▾

Cough Suppressant

📄 Do Not Use 111 words ▾

Do not use this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. 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. Stop use and ask a doctor if cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache.

🤰 If Pregnant or Breast-Feeding 10 words ▾

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

📄 Keep Out of Reach of Children 22 words ▾

Keep Out of Reach of Children. In case of accidental overdose, get medical help or contact the Poison Control Center right away.

📄 Questions or Comments 10 words ▾

Questions or Comments? 305.805.3456 Monday-Friday 9AM to 5PM EST www.efficientlabs.com

📄 Package Label / Principal Display Panel 1 words ▾

Mielim

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 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 ✓ 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.
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 58593-295-04, 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: 58593-0295-04, written without dashes as 58593029504. 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 58593-0295-04, the first segment (58593) is the labeler code FDA assigned to Efficient Laboratories Inc.; the middle segment (0295) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 178 ml (58593-0295-06). 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?
Efficient Laboratories 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.
← 58593-0288-04 · Efficient 58593-0601-15 · Efficient →
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.