Home › NDC Lookup › Ingredients › Promethazine Hydrochloride And Dextromet... › 31722-0692-47
🧴image loading
(from DailyMed)

PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 6.25 mg/5mL; 15 mg/5mL Solution, 473 mL — NDC 31722-692-47 (Billing 31722-0692-47)

by Camber Pharmaceuticals, Inc. · 473 mL in 1 BOTTLE

This is a package of 473 mL of PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 6.25 mg/5mL; 15 mg/5mL Solution from Camber Pharmaceuticals, Inc., marketed since Mar 2026 and currently FDA-listed.

NDC 31722-0692-47
🏷️ FDA NDC (as labeled) 31722-692-47 billing pads the product segment with a zero
This package
Contains473 mL Pack sizes2 compare ↓
Product page 31722-0692-11 Also comes in: 118 ml 31722-692-11
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 31722-692-47
Product NDC 31722-692
11-digit billing NDC 31722069247
RxCUI 991528
UNII R61ZEH7I1I, 9D2RTI9KYH
UPC 0331722692113, 0331722692472
Application # ANDA218264
SPL Set ID 6a2cd2d6-6e0f-4b2d-be7a-8b99627f4453
Established class (EPC) Phenothiazine; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of action Sigma-1 Receptor Agonists; Uncompetitive NMDA Receptor Antagonists
Chemical class Phenothiazines
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-03-12
Route ORAL
Dosage form SOLUTION
Substance PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
TE code (Orange Book) AA · RLD · RS
Quick answers
  • RxCUI (RxNorm): 991528
Why two NDCs? The FDA registers this code as 31722-692-47 — 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 → 31722-0692-47. 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

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.

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: 118 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
31722-0692-11 31722-692-11 Main listing 118 mL in 1 BOTTLE 2026-03-12 — Active
31722-0692-47 You're viewing this 473 mL in 1 BOTTLE 2026-03-12 — Active

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

Pack size FAQ

What quantity is in this package?
This package contains 473 mL — 473 ml in 1 bottle.
How does this package differ from NDC 31722-0692-11?
Both are PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 6.25 mg/5mL; 15 mg/5mL Solution — the drug itself is identical. This page's package is the 473 mL one, while NDC 31722-0692-11 is the 118 ml package.
What NDC number is used to bill for this package of PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 6.25 mg/5mL; 15 mg/5mL Solution?
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Promethazine Hydrochloride and Dextromethorphan Hydrobromide 6.25 mg/5mL; 15 mg/5mL 00116-4024-16 Xttrium 473 ml $0.039 AA Availability likely —
Promethazine Hydrochloride and Dextromethorphan Hydrobromide 6.25 mg/5mL; 15 mg/5mL 00713-0780-75 Cosette 473 ml $0.039 AA Availability likely —
Promethazine Hydrochloride and Dextromethorphan Hydrobromide 6.25 mg/5mL; 15 mg/5mL 27808-0057-01 Cranbury 473 ml $0.039 AA Availability likely —
Promethazine Hydrochloride and Dextromethorphan Hydrobromide 6.25 mg/5mL; 15 mg/5mL 65162-0680-86 Amneal 118 ml $0.051 AA Availability likely —
Promethazine DM 15 mg/5mL; 6.25 mg/5mL 00121-1070-04 PAI 118 ml — AA FDA listed —
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution 15 mg/5mL; 6.25 mg/5mL 17856-0155-01 ATLANTIC 72 cups — AA FDA listed —
Promethazine Hydrochloride and Dextromethorphan Hydrobromide 6.25 mg/5mL; 15 mg/5mL 17856-4024-01 Atlantic 72 cups — AA FDA listed —
Promethazine Hydrochloride And Dextromethorphan Hydrobromide 6.25 mg/5mL; 15 mg/5mLthis 31722-0692-47 Camber 473 ml — AA FDA listed —
Promethazine Hydrochloride and Dextromethorphan Hydrobromide 6.25 mg/5mL; 15 mg/5mL 50090-6467-00 A-S 473 ml — AA FDA listed —
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral 15 mg/5mL; 6.25 mg/5mL 50090-6585-00 A-S 118 ml — AA FDA listed —
Promethazine Hydrochloride and Dextromethorphan Hydrobromide 6.25 mg/5mL; 15 mg/5mL 50090-6755-00 A-S 473 ml — AA FDA listed —
Promethazine Hydrochloride and Dextromethorphan Hydrobromide 6.25 mg/5mL; 15 mg/5mL 50090-7658-00 A-S 473 ml — AA FDA listed —
Promethazine Hydrochloride and Dextromethorphan Hydrobromide 6.25 mg/5mL; 15 mg/5mL 62559-0758-04 ANI 118 ml — AA FDA listed —
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution 15 mg/5mL; 6.25 mg/5mL 68071-3551-04 NuCare 118 ml — AA FDA listed —
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution 15 mg/5mL; 6.25 mg/5mL 68788-8100-01 Preferred 118 ml — AA Discontinued —
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution 15 mg/5mL; 6.25 mg/5mL 71205-0654-04 Proficient 118 ml — AA FDA listed —
Promethazine Hydrochloride and Dextromethorphan Hydrobromide 6.25 mg/5mL; 15 mg/5mL 72162-2039-02 Bryant 473 ml — AA FDA listed —
Promethazine Hydrochloride and Dextromethorphan Hydrobromide 6.25 mg/5mL; 15 mg/5mL 76420-0335-04 Asclemed 118 ml — AA FDA listed —
Promethazine Hydrochloride and Dextromethorphan Hydrobromide 6.25 mg/5mL; 15 mg/5mL 72888-0038-01 Advagen 473 ml — AA FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2026
On the market since
Mar 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII PQ6CK8PD0R
    Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
  • 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 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 L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • 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 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 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 B22547B95K
    A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
  • 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.

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

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

LabelerCamber Pharmaceuticals, Inc.
Application holderHETERO LABS LTD UNIT III
FDA applicationANDA218264 (ANDA)
Labeler code31722
First marketedMar 2026
Product typeHuman Prescription Drug
Portfolio603 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🔄 Drug / Laboratory Test Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🔒 Drug Abuse and Dependence 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 29 words ▾

INDICATIONS AND USAGE Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.

⏱️ Dosage and Administration 193 words ▾

DOSAGE AND ADMINISTRATION It is important that promethazine hydrochloride and dextromethorphan hydrobromide oral solution is measured with an accurate measuring device (see PRECAUTIONS-Information for Patients). A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is to be measured. It is strongly recommended that an accurate measuring device be used.

A pharmacist can provide an appropriate device and can provide instructions for measuring the correct dose. Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is CONTRAINDICATED for children under 2 years of age (see WARNINGS – Boxed Warning and Use in Pediatric Patients). The average effective dose for adults is 5 mL (one teaspoon) every 4 to 6 hours, not to exceed 30 mL in 24 hours.

For children 6 years to under 12 years of age, the dose is 2.5 to 5 mL (one-half to one teaspoon) every 4 to 6 hours, not to exceed 20 mL in 24 hours. For children 2 years to under 6 years of age, the dose is 1.25 to 2.5 mL (one-quarter to one-half teaspoon) every 4 to 6 hours, not to exceed 10 mL in 24 hours.

⛔ Contraindications 80 words ▾

CONTRAINDICATIONS Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is contraindicated for use in pediatric patients less than two years of age. Promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma.

Dextromethorphan should not be used in patients receiving a monoamine oxidase inhibitor (MAOI) (see PRECAUTIONS – Drug Interactions).

⚠️ Warnings ~2 min read ▾

WARNINGS Promethazine hydrochloride and dextromethorphan hydrobromide oral solution should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression. Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine in pediatric patients less than 2 years of age. A wide range of weight-based doses of promethazine have resulted in respiratory depression in these patients.

Caution should be exercised when administering promethazine to pediatric patients 2 years of age and older. It is recommended that the lowest effective dose of promethazine be used in pediatric patients 2 years of age and older and concomitant administration of other drugs with respiratory depressant effects be avoided. PROMETHAZINE CNS Depression Promethazine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery.

The impairment may be amplified by concomitant use of other central-nervous-system depressants such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore such agents should either be eliminated or given in reduced dosage in the presence of promethazine hydrochloride (see PRECAUTIONS - Information for Patients and Drug Interactions). Respiratory Depression Promethazine may lead to potentially fatal respiratory depression.

Use of promethazine hydrochloride and dextromethorphan hydrobromide oral solution in patients with compromised respiratory function (e.g. COPD, sleep apnea syndrome) should be avoided. Lower Seizure Threshold Promethazine may lower seizure threshold.

It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold. Bone-Marrow Depression Promethazine hydrochloride and dextromethorphan hydrobromide oral solution should be used with caution in patients with bone-marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine hydrochloride has been used in association with other known marrow-toxic agents.

Neuroleptic Malignant Syndrome A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine hydrochloride alone or in combination with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias). The diagnostic evaluation of patients with this syndrome is complicated.

In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g. pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology. The management of NMS should include 1) immediate discontinuation of promethazine hydrochloride, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available.

There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine hydrochloride should be carefully considered. Use in Pediatric Patients Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is contraindicated for use… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions 207 words ▾

ADVERSE REACTIONS PROMETHAZINE Central Nervous System – Drowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness; confusion, disorientation and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. Hallucinations have also been reported.

Cardiovascular – Increased or decreased blood pressure, tachycardia, bradycardia, faintness. Dermatologic – Dermatitis, photosensitivity, urticaria. Hematologic – Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis.

Gastrointestinal – Dry mouth, nausea, vomiting, jaundice. Respiratory – Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal) (see WARNINGS –Respiratory Depression.) Other – Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been reported (see WARNINGS –Neuroleptic Malignant Syndrome.) Paradoxical Reactions Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine hydrochloride and dextromethorphan hydrobromide oral solution.

Consideration should be given to the discontinuation of promethazine hydrochloride and to the use of other drugs if these reactions occur. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients. DEXTROMETHORPHAN Dextromethorphan hydrobromide occasionally causes slight drowsiness, dizziness, and gastrointestinal disturbances.

To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~1 min read ▾

Drug Interactions Monoamine Oxidase (MAO) Inhibitors – Hyperpyrexia, hypotension, and death have been reported coincident with the co-administration of monoamine oxidase (MAO) inhibitors and products containing dextromethorphan. Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAO inhibitors and phenothiazines are used concomitantly. Thus, concomitant administration of promethazine hydrochloride and dextromethorphan hydrobromide oral solution and MAO inhibitors should be avoided (see CONTRAINDICATIONS).

CNS Depressants – Promethazine may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine. When given concomitantly with promethazine hydrochloride and dextromethorphan hydrobromide oral solution, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half.

Dosage must be individualized. Excessive amounts of promethazine hydrochloride relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain. Epinephrine – Because of the potential for promethazine to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine hydrochloride and dextromethorphan hydrobromide overdose.

Anticholinergics – Concomitant use of other agents with anticholinergic properties should be undertaken with caution.

🔄 Drug / Laboratory Test Interactions 54 words ▾

Drug/Laboratory Test Interactions The following laboratory tests may be affected in patients who are receiving therapy with promethazine hydrochloride: Pregnancy Tests Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. Glucose Tolerance Test An increase in blood glucose has been reported in patients receiving promethazine.

🤰 Pregnancy ~1 min read ▾

Pregnancy Teratogenic Effects Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine hydrochloride. These doses are 8.3 and 16.7 times the maximum recommended total daily dose for a 50 kg subject. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats.

Specific studies to test the action of promethazine on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines, including promethazine have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of promethazine in pregnant women.

Animal reproduction studies have not been conducted with the drug combination – promethazine and dextromethorphan. It is not known whether this drug combination can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Promethazine hydrochloride and dextromethorphan hydrobromide oral solution should be given to a pregnant woman only if clearly needed.

Promethazine hydrochloride and dextromethorphan hydrobromide oral solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects Promethazine administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn.

🧒 Pediatric Use 60 words ▾

Pediatric Use Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is contraindicated for use in pediatric patients less than two years of age (see WARNINGS – Boxed Warning and Use in Pediatric Patients). Promethazine hydrochloride and dextromethorphan hydrobromide oral solution should be used with caution in pediatric patients 2 years of age and older (see WARNINGS – Use in Pediatric Patients).

🧓 Geriatric Use 112 words ▾

Geriatric Use Clinical studies of promethazine hydrochloride formulations did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of promethazine hydrochloride and dextromethorphan hydrobromide and observed closely.

🆘 Overdosage ~2 min read ▾

OVERDOSAGE PROMETHAZINE Signs and symptoms of overdosage with promethazine hydrochloride range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and sudden death. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis and extensor-plantar reflexes (Babinski reflex). Stimulation may be evident, especially in children and geriatric patients.

Convulsions may rarely occur. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. Atropine-like signs and symptoms – dry mouth, fixed, dilated pupils, flushing, as well as gastrointestinal symptoms-may occur.

DEXTROMETHORPHAN Dextromethorphan may produce central excitement and mental confusion. Very high doses may produce respiratory depression. One case of toxic psychosis (hyperactivity, marked visual and auditory hallucinations) after ingestion of a single dose of 20 tablets (300 mg) of dextromethorphan has been reported.

Treatment Treatment of overdosage with promethazine hydrochloride and dextromethorphan hydrobromide oral solution is essentially symptomatic and supportive. Only in cases of extreme overdosage or individual sensitivity do vital signs, including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic.

Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. Diazepam may be used to control convulsions. Acidosis and electrolyte losses should be corrected.

The antidotal efficacy of narcotic antagonists to dextromethorphan has not been established; note that any of the depressant effects of promethazine are not reversed by naloxone. Avoid analeptics, which may cause convulsions. The treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied by repositioning if indicated.

In the event that vasopressors are considered for the management of severe hypotension which does not respond to intravenous fluids and repositioning, the administration of norepinephrine or phenylephrine should be considered. EPINEPHRINE SHOULD NOT BE USED, since its use in a patient with partial adrenergic blockade may further lower the blood pressure. Extrapyramidal reactions may be treated with anticholinergic antiparkinson agents, diphenhydramine, or barbiturates.

Oxygen may also be administered. Limited experience with dialysis indicates that it is not helpful.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY PROMETHAZINE Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Promethazine is an H 1 receptor blocking agent.

In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours.

Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine. DEXTROMETHORPHAN Dextromethorphan is an antitussive agent and, unlike the isomeric levorphanol, it has no analgesic or addictive properties. Dextromethorphan acts centrally and elevates the threshold for coughing.

It is about equal to codeine in depressing the cough reflex. In therapeutic dosage dextromethorphan does not inhibit ciliary activity. Dextromethorphan is rapidly absorbed from the gastrointestinal tract and exerts its effect in 15 to 30 minutes.

The duration of action after oral administration is approximately three to six hours. Dextromethorphan is metabolized primarily by liver enzymes undergoing O-demethylation, N-demethylation, and partial conjugation with glucuronic acid and sulfate. In humans, (+)-3-hydroxy-N-methylmorphinan, (+)-3-hydroxymorphinan, and traces of unmetabolized drug were found in urine after oral administration.

📦 How Supplied / Storage and Handling 112 words ▾

HOW SUPPLIED Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is a clear oral solution with yellow color and orange-pineapple menthol flavor. These are supplied as follows: NDC 31722-692-11 – bottle of 4 fl. oz. (118 mL) NDC 31722-692-47 – bottle of 16 fl. oz.

(473 mL) Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep tightly closed. Protect from light.

Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP. Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: HETERO TM Hetero Labs Limited Jeedimetla, Hyderabad - 500 055, India.

Revised: 03/2026 camberlogo

📋 Description ~1 min read ▾

DESCRIPTION Each teaspoon (5 mL) of promethazine hydrochloride and dextromethorphan hydrobromide oral solution contains 6.25 mg promethazine hydrochloride, USP and 15 mg dextromethorphan hydrobromide, USP in a flavored oral solution base with a pH between 4.7 and 5.2. Alcohol 7%. The inactive ingredients present are ascorbic acid, citric acid, D&C yellow #10, FD&C yellow #6, menthol, methylparaben, orange flavor (contains ethyl alcohol, nature-identical flavouring substances, flavoring preparations, propylene glycol and water), pineapple flavor (contains artificial flavouring substances, flavoring preparations, nature-identical flavouring substances and propylene glycol), propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sucrose and trisodium citrate dihydrate.

Promethazine, USP is a racemic compound; The molecular formula is C 17 H 20 N 2 S•HCI, and its molecular weight is 320.88. Promethazine hydrochloride, USP a phenothiazine derivative, is chemically designated as (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride with the following structural formula: Promethazine hydrochloride, USP occurs as a white or faintly yellowish crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is very soluble in water, freely soluble in ethanol and in methanol, practically insoluble in ethyl acetate, diethyl ether and acetone.

Dextromethorphan hydrobromide, USP is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically designated as 3-methoxy-17-methyl-9α, 13α, 14α-morphinan hydrobromide monohydrate with the following structural formula: Dextromethorphan hydrobromide, USP occurs as practically white crystals or crystalline powder having faint odour, freely soluble in alcohol and chloroform, sparingly soluble in water, insoluble in ether. The molecular formula is C 18 H 25 NO•HBr•H 2 O, and the molecular weight of 370.32. promethazinestructure promethazinestructure2

💬 Information for Patients 191 words ▾

Information for Patients Patients should be advised to measure promethazine hydrochloride and dextromethorphan hydrobromide oral solution with an accurate measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when a half a teaspoon is measured. A pharmacist can recommend an appropriate measuring device and can provide instructions for measuring the correct dose.

Promethazine hydrochloride and dextromethorphan hydrobromide oral solution may cause marked drowsiness or impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Ambulatory patients should be told to avoid engaging in such activities until it is known that they do not become drowsy or dizzy from promethazine and dextromethorphan therapy. Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities.

The concomitant use of alcohol or other central-nervous-system depressants, such as sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers, may enhance impairment (see WARNINGS – CNS Depression and PRECAUTIONS – Drug Interactions). Patients should be advised to report any involuntary muscle movements. Avoid prolonged exposure to the sun.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction and bladder-neck obstruction. Promethazine hydrochloride and dextromethorphan hydrobromide oral solution should be used cautiously in persons with cardiovascular disease or with impairment of liver function. Dextromethorphan should be used with caution in sedated patients, in the debilitated, and in patients confined to the supine position.

Information for Patients Patients should be advised to measure promethazine hydrochloride and dextromethorphan hydrobromide oral solution with an accurate measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when a half a teaspoon is measured. A pharmacist can recommend an appropriate measuring device and can provide instructions for measuring the correct dose.

Promethazine hydrochloride and dextromethorphan hydrobromide oral solution may cause marked drowsiness or impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Ambulatory patients should be told to avoid engaging in such activities until it is known that they do not become drowsy or dizzy from promethazine and dextromethorphan therapy. Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities.

The concomitant use of alcohol or other central-nervous-system depressants, such as sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers, may enhance impairment (see WARNINGS – CNS Depression and PRECAUTIONS – Drug Interactions). Patients should be advised to report any involuntary muscle movements. Avoid prolonged exposure to the sun.

Drug Interactions Monoamine Oxidase (MAO) Inhibitors – Hyperpyrexia, hypotension, and death have been reported coincident with the co-administration of monoamine oxidase (MAO) inhibitors and products containing dextromethorphan. Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAO inhibitors and phenothiazines are used concomitantly. Thus, concomitant administration of promethazine hydrochloride and dextromethorphan hydrobromide oral solution and MAO inhibitors should be avoided (see CONTRAINDICATIONS).

CNS Depressants – Promethazine may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine. When given concomitantly with promethazine hydrochloride and dextromethorphan hydrobromide oral solution, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half.

Dosage must be individualized. Excessive amounts of promethazine hydrochloride relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain. Epinephrine – Because of the potential for promethazine to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine hydrochloride and dextromethorphan hydrobromide overdose.

Anticholinergics – Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Drug/Laboratory Test Interactions The following laboratory tests may be affected in patients who are receiving therapy with promethazine hydrochloride: Pregnancy Tests Diagnostic pregnancy tests based on immunological reactions… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 68 words ▾

Nursing Mothers It is not known whether promethazine or dextromethorphan is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from promethazine hydrochloride and dextromethorphan hydrobromide oral solution, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

🔒 Drug Abuse and Dependence 24 words ▾

DRUG ABUSE AND DEPENDENCE According to the WHO Expert Committee on Drug Dependence, dextromethorphan could produce very slight psychic dependence but no physical dependence.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 49 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to assess the carcinogenic potential of promethazine or of dextromethorphan. There are no animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility with these drugs. Promethazine was nonmutagenic in the Salmonella test system of Ames.

📄 Package Label / Principal Display Panel 22 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution-Container-Label-118 mL Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution-Container-Label-473 mL promethazinelabel118ml promethazinelabel473ml

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

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 Promethazine Hydrochloride and Dextromethorphan Hydrobromide — the ingredient across all brands.

Top reported reactions

Pain58
Nausea55
Fatigue53
Headache51
Diarrhoea46
Cough44
Dyspnoea42

Age at onset

Adolescent2
Adult106
Elderly41

Reporter sex

598 reports
Male · 30%
Female · 70%

Serious outcomes

Death30
Disabling18
Life-threatening14
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 79 28
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.

About this NDC listing & data coverage

Finished prescription 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) ✓ 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 ✓ Available
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

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: this package is listed as actively marketed, with no marketing end date reported by Camber Pharmaceuticals, 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 118 ml (31722-0692-11). 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?
Camber Pharmaceuticals, 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
← 31722-0691-11 · Camber 31722-0693-60 · Camber →
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.