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Dicyclomine Hydrochloride 10 mg/5mL Solution, 473 mL — NDC 70954-261-10 (Billing 70954-0261-10)

by Novitium Pharma LLC · 473 mL in 1 BOTTLE

This is a package of 473 mL of Dicyclomine Hydrochloride 10 mg/5mL Solution from Novitium Pharma LLC, marketed since Apr 2021 and currently FDA-listed; retail pharmacies pay about $0.1736 per mL (NADAC). It is this product's only package size.

NDC 70954-0261-10
🏷️ FDA NDC (as labeled) 70954-261-10 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ 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

NDC database record

One package, one record: these facts belong to NDC 70954-261-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
70954 labeler · 261 product · 10 package
Package marketed since
Apr 23, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
473 mL per package
Barcode (UPC)
0370954261100
Medicaid fills, this package
12,600 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Dicyclomine Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jul 23, 2026 — shortfill; reports of empty capsules. (Aurobindo Pharma USA Inc) · FDA recall D-0733-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70954-261-10
Product NDC 70954-261
11-digit billing NDC 70954026110
NCPDP billing unit ML — per mL (volume)
RxCUI 991082
UNII CQ903KQA31
UPC 0370954261100
Application # ANDA214721
SPL Set ID b0911994-0b36-439d-8247-5d885a899421
Established class (EPC) Anticholinergic
Mechanism of action Cholinergic Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-04-23
Route ORAL
Dosage form SOLUTION
Substance DICYCLOMINE HYDROCHLORIDE
TE code (Orange Book) AA · RLD · RS

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

GPI-14 49103010102050
GPI class Dicyclomine HCl
GCN Seq No 071032
GCN 34719
HICL code 002045
Ingredient (HICL) Dicyclomine Hcl
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J2
Therapeutic class — intermediate (HIC2) Anticholinergics
HIC3 code J2D
Therapeutic class — specific (HIC3) Anticholinergics/Antispasmodics
AHFS code 12:08.08.00
AHFS class Antimuscarinics/Antispasmodics
FDB label name DICYCLOMINE 10 MG/5 ML SOLN
FDB brand name Dicyclomine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 071032
  • GCN: 34719
  • GPI-14 (Medi-Span): 49103010102050
  • HICL (First Databank): 002045
  • AHFS class code: 12:08.08.00
  • RxCUI (RxNorm): 991082
Why two NDCs? The FDA registers this code as 70954-261-10 — 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 → 70954-0261-10. 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 Anticholinergic class.

Pharmacologic class Anticholinergic
Drug family (ATC) Synthetic anticholinergics, esters with tertiary amino group
How it works Cholinergic 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 DICYCLOMINE 10 MG/5 ML SOLN Ingredient Dicyclomine Hcl
📗 Our plain-language guide HelloPharmacist
  • It treats functional bowel/irritable bowel syndrome. It helps calm the spasms and cramping in your intestines.
  • The capsules, tablets and solution are taken by mouth, generally four times a day. Your prescriber may adjust the amount after a week or so. If you miss a dose, just carry on with...
  • Dry mouth, dizziness and blurred vision are the most common. Nausea, drowsiness, weakness and nervousness can happen too. Be careful driving until you know how it affects you.
  • Call if you feel confused, see or hear things that aren't there, have a racing heartbeat, or can't pass urine. Also call if you overheat without sweating or have diarrhea with a co...
📖 Read our full Dicyclomine guide →

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 $0.174 $82.11 / 473 ml
Medicaid paysCMS SDUD · 12 mo $0.1880 $88.92 / 473 ml
Medicare drug plans payPart D · Q2 2026 $0.2010 $95.07 / 473 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Sep 2022 Feb 2026 Sep 2026 $0.210 $0.174
▼ Down 14% 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
70954-0261-10 You're viewing this Main listing 473 mL in 1 BOTTLE 2021-04-23 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dicyclomine Hydrochloride 10 mg/5mL 00054-0622-63 Hikma 473 ml $0.174 AA Availability likely —
dicyclomine hydrochloride 10 mg/5mL 00603-1161-58 Par 473 ml $0.174 AA Availability likely —
Dicyclomine Hydrochloride 10 mg/5mLthis 70954-0261-10 Novitium 473 ml $0.174 AA Availability likely —
Dicyclomine Hydrochloride 10 mg/5mL 17856-2261-01 ATLANTIC 72 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

🏛️
2021
On the market since
Apr 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
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.

🧪 Avoiding an ingredient? See Dicyclomine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII PN2ZH5LOQY
    A synthetic red dye approved by the FDA for use in foods, medicines, and cosmetics. It serves as a colorant to make tablets, capsules, and liquids visually distinctive for product identification.
  • 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 PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • 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 A9CO00M9HV
    Saccharin sodium monohydrate is an artificial sweetener derived from saccharin. It's added to medicines to improve taste and mask bitter flavors, making medications easier to take.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in 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 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.

10 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

LabelerNovitium Pharma LLC
Application holderNOVITIUM PHARMA LLC
FDA applicationANDA214721 (ANDA)
Labeler code70954
First marketedApr 2021
Product typeHuman Prescription Drug
Portfolio17 products on file

More NDCs from Novitium Pharma LLC labeler code 70954

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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 37 words ▾

1 INDICATIONS & USAGE Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome (1)

⏱️ Dosage and Administration 183 words ▾

2 DOSAGE & ADMINISTRATION Dosage must be adjusted to individual patient needs. Dosage for dicyclomine hydrochloride must be adjusted to individual patient needs (2). If a dose is missed, patients should continue the normal dosing schedule (2).

Oral in adults (2.1): Starting dose: 20 mg four times a day. After a week treatment with the starting dose, the dose may be escalated to 40 mg four times a day, unless side effects limit dosage escalation. Discontinue dicyclomine hydrochloride if efficacy not achieved or side effects require doses less than 80 mg per day after two weeks of treatment.

2.1Oral Dosage and Administration in Adults The recommended initial dose is 20 mg four times a day. After one week treatment with the initial dose, the dose may be increased to 40 mg four times a day unless side effects limit dosage escalation. If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued.

Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.

💊 Dosage Forms and Strengths 20 words ▾

3 DOSAGE FORMS & STRENGTHS Dicyclomine hydrochloride oral solution 10 mg/5 mL Dicyclomine hydrochloride oral solution 10 mg/5 mL (3)

⛔ Contraindications 136 words ▾

4 CONTRAINDICATIONS Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [ see Use in Specific Populations (8.4) ], nursing mothers [ see Use in Specific Populations (8.3) ], and in patients with: unstable cardiovascular status in acute hemorrhage myasthenia gravis [ see Warnings and Precautions (5.4) ] glaucoma [ see Adverse Reactions (6.3) and Drug Interactions (7.1) ] obstructive uropathy [ see Warnings and Precautions (5.8) ] obstructive disease of the gastrointestinal tract [ see Warnings and Precautions (5.5) ] severe ulcerative colitis [ see Warnings and Precautions (5.7) ] reflux esophagitis Infants less than 6 months of age (4) Nursing mothers (4) Unstable cardiovascular status in acute hemorrhage (4) Myasthenia gravis (4) Glaucoma (4) Obstructive uropathy (4) Obstructive disease of the gastrointestinal tract (4) Severe ulcerative colitis (4) Reflux esophagitis (4)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Cardiovascular conditions : worsening of conditions (5.2) Peripheral and central nervous system : heat prostration can occur with drug use (fever and heat stroke due to decreased sweating); drug should be discontinued and supportive measures instituted (5.3) Psychosis in patients sensitive to anticholinergic drugs : signs and symptoms resolve within 12 to 24 hours after discontinuation of dicyclomine hydrochloride (5.3) Myasthenia Gravis : overdose may lead to muscular weakness and paralysis.

Dicyclomine hydrochloride should be given to patients with myasthenia gravis only to reduce adverse muscarinic effects of an anticholinesterase (5.4) Incomplete intestinal obstruction : diarrhea may be an early symptom especially in patients with ileostomy or colostomy. Treatment with dicyclomine hydrochloride would be inappropriate and possibly fatal (5.5) Salmonella dysenteric patients : due to risk of toxic megacolon (5.6) Ulcerative colitis : dicyclomine hydrochloride should be used with caution in these patients; large doses may suppress intestinal motility or aggravate the serious complications of toxic megacolon (5.7) Prostatic hypertrophy : dicyclomine hydrochloride should be used with caution in these patients; may lead to urinary retention (5.8) Hepatic and renal disease : should be used with caution (5.9) Geriatric : use with caution in elderly who may be more susceptible to dicyclomine hydrochloride’s adverse events (5.10)

5.2Cardiovascular Conditions Dicyclomine hydrochloride needs to be used with caution in conditions characterized by tachyarrhythmia such as thyrotoxicosis, congestive heart failure and in cardiac surgery, where they may further accelerate the heart rate. Investigate any tachycardia before administration of dicyclomine hydrochloride. Care is required in patients with coronary heart disease, as ischemia and infarction may be worsened, and in patients with hypertension [ see Adverse Reactions (6.3) ].

5.3Peripheral and Central Nervous System The peripheral effects of dicyclomine hydrochloride are a consequence of their inhibitory effect on muscarinic receptors of the autonomic nervous system. They include dryness of the mouth with difficulty in swallowing and talking, thirst, reduced bronchial secretions, dilatation of the pupils (mydriasis) with loss of accommodation (cycloplegia) and photophobia, flushing and dryness of the skin, transient bradycardia followed by tachycardia, with palpitations and arrhythmias, and difficulty in micturition, as well as reduction in the tone and motility of the gastrointestinal tract leading to constipation [ see Adverse Reactions (6) ].

In the presence of high environmental temperature heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). It should also be used cautiously in patients with fever. If symptoms occur, the drug should be discontinued and supportive measures instituted.

Because of the inhibitory effect on muscarinic receptors within the autonomic nervous system, caution should be taken in patients with autonomic neuropathy. Central nervous system (CNS) signs and symptoms include confusion, disorientation, short-term amnesia, hallucinations, dysarthria, ataxia, coma, euphoria, fatigue, insomnia, agitation and mannerisms, and inappropriate affect. Psychosis has been reported in sensitive individuals given anticholinergic drugs.

These CNS signs and symptoms usually resolve within 12 to 24 hours after discontinuation of the drug. Dicyclomine hydrochloride may produce drowsiness, dizziness or blurred vision. The patient should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery or performing hazardous work while taking dicyclomine hydrochloride.

5.4Myasthenia Gravis With overdosage, a curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis). It should not be given to patients with mya… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The pattern of adverse effects seen with dicyclomine is mostly related to its pharmacological actions at muscarinic receptors [ see Clinical Pharmacology (12) ]. They are a consequence of the inhibitory effect on muscarinic receptors within the autonomic nervous system. These effects are dose-related and are usually reversible when treatment is discontinued.

The most serious adverse reactions reported with dicyclomine hydrochloride include cardiovascular and central nervous system symptoms [ see Warnings and Precautions (5.2,5.3) ]. The most serious adverse reactions include cardiovascular and central nervous system symptoms. The most common adverse reactions (>5% of patients) are dizziness, dry mouth, vision blurred, nausea, somnolence, asthenia and nervousness (6) To report SUSPECTED ADVERSE REACTIONS, contact Novitium Pharma LLC at 1-855-204-1431 or the FDA at 1-800-FDA-1088 or www.fda.g ov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure in controlled clinical trials involving over 100 patients treated for functional bowel/irritable bowel syndrome with dicyclomine hydrochloride at initial doses of 160 mg daily (40 mg four times a day).

In these trials most of the side effects were typically anticholinergic in nature and were reported by 61% of the patients. Table 1 presents adverse reactions ( MedDRA 13.0 preferred terms) by decreasing order of frequency in a side-by-side comparison with placebo. Table 1: Adverse reactions experienced in controlled clinical trials with decreasing order of frequency MedDRA Preferred Term Dicyclomine Hydrochloride (40 mg four times a day) % Placebo % Dry Mouth 33 5 Dizziness 40 5 Vision blurred 27 2 Nausea 14 6 Somnolence 9 1 Asthenia 7 1 Nervousness 6 2 Nine percent (9%) of patients were discontinued from dicyclomine hydrochloride because of one or more of these side effects (compared with 2% in the placebo group).

In 41% of the patients with side effects, side effects disappeared or were tolerated at the 160 mg daily dose without reduction. A dose reduction from 160 mg daily to an average daily dose of 90 mg was required in 46% of the patients with side effects who then continued to experience a favorable clinical response; their side effects either disappeared or were tolerated.

6.2Postmarketing Experience The following adverse reactions, presented by system organ class in alphabetical order, have been identified during post approval use of dicyclomine hydrochloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiac disorders : palpitations, tachyarrhythmias Eye disorders : cycloplegia, mydriasis, vision blurred Gastrointestinal disorders : abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, nausea, vomiting General disorders and administration site conditions : fatigue, malaise Immune System Disorders : drug hypersensitivity including face oedema, angioedema, anaphylactic shock Nervous system disorders : dizziness, headache, hallucinations, insomnia, somnolence, syncope Psychiatric disorders : confusional state, nervousness Reproductive system and breast disorders : suppressed lactation Respiratory, thoracic and mediastinal disorders : dyspnoea, nasal congestion Skin and subcutaneous tissue disorder : dermatitis allergic, erythema, rash

6.3Adverse Reactions Reported with Similar Drugs with Anticholinergic/Antispasmodic Action Gastrointestinal: anorexia Central Nervous System: tingling, numbness, dyskinesia, speech disturbance, insomnia Peripheral Nervous System: With overdosage, a curare-like ac… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Antiglaucoma agents : anticholinergics antagonize antiglaucoma agents and may increase intraoccular pressure (7) Anticholinergic agents : may affect the gastrointestinal absorption of various drugs; may also increase certain actions or side effects of other anticholinergic drugs (7) Antacids : interfere with the absorption of anticholinergic agents (7)

7.1Antiglaucoma Agents Anticholinergics antagonize the effects of antiglaucoma agents. Anticholinergic drugs in the presence of increased intraocular pressure may be hazardous when taken concurrently with agents such as corticosteroids. Use of dicyclomine hydrochloride in patients with glaucoma is not recommended [ see Contraindications (4) ].

7.2Other Drugs with Anticholinergic Activity The following agents may increase certain actions or side effects of anticholinergic drugs including dicyclomine hydrochloride: amantadine, antiarrhythmic agents of Class I (e.g., quinidine), antihistamines, antipsychotic agents (e.g., phenothiazines), benzodiazepines, MAO inhibitors, narcotic analgesics (e.g., meperidine), nitrates and nitrites, sympathomimetic agents, tricyclic antidepressants, and other drugs having anticholinergic activity

7.3Other Gastrointestinal Motility Drugs Interaction with other gastrointestinal motility drugs may antagonize the effects of drugs that alter gastrointestinal motility, such as metoclopramide.

7.4Effect of Antacids Because antacids may interfere with the absorption of anticholinergic agents including dicyclomine hydrochloride, simultaneous use of these drugs should be avoided.

7.5Effect on Absorption of Other Drugs Anticholinergic agents may affect gastrointestinal absorption of various drugs by affecting on gastrointestinal motility, such as slowly dissolving dosage forms of digoxin; increased serum digoxin concentration may result.

7.6Effect on Gastric Acid Secretion The inhibiting effects of anticholinergic drugs on gastric hydrochloric acid secretion are antagonized by agents used to treat achlorhydria and those used to test gastric secretion.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: use only if clearly needed (8.1) Pediatric Use: safety and effectiveness not established (8.4) Hepatic and renal impairment: caution must be taken with patients with significantly impaired hepatic and renal function (8.6)

8.1Pregnancy Pregnancy Category B Adequate and well-controlled studies have not been conducted with dicyclomine hydrochloride in pregnant women at the recommended doses of 80 to 160 mg/day. However, epidemiologic studies did not show an increased risk of structural malformations among babies born to women who took products containing dicyclomine hydrochloride at doses up to 40 mg/day during the first trimester of pregnancy. Reproduction studies have been performed in rats and rabbits at doses up to 33 times the maximum recommended human dose based on 160 mg/day (3 mg/kg) and have revealed no evidence of harm to the fetus due to dicyclomine.

Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

8.3Nursing Mothers Dicyclomine hydrochloride is contraindicated in women who are human milk feeding. Dicyclomine hydrochloride is excreted in human milk. Because of the potential for serious adverse reactions in human breastfed infants from dicyclomine hydrochloride, 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 [ see Use in Specific Populations (8.4) ].

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established. Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [ see Contrainidications (4) ]. There are published cases reporting that the administration of dicyclomine hydrochloride to infants has been followed by serious respiratory symptoms (dyspnea, shortness of breath, breathlessness, respiratory collapse, apnea and asphyxia), seizures, syncope, pulse rate fluctuations, muscular hypotonia, and coma, and death, however; no causal relationship has been established.

8.5Geriatric Use Clinical studies of dicyclomine hydrochloride 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 in adults, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

8.6Renal Impairment Effects of renal impairment on PK, safety and efficacy of dicyclomine hydrochloride have not been studied. Dicyclomine hydrochloride drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Dicyclomine hydrochloride should be administered with caution in patients with renal impairment.

8.7Hepatic Impairment Effects of renal impairment on PK, safety and efficacy of dicyclomine hydrochloride have not been studied. Dicyclomine hydrochloride should be administered with caution in patients with hepatic impairment.

🤰 Pregnancy 124 words ▾

8.1Pregnancy Pregnancy Category B Adequate and well-controlled studies have not been conducted with dicyclomine hydrochloride in pregnant women at the recommended doses of 80 to 160 mg/day. However, epidemiologic studies did not show an increased risk of structural malformations among babies born to women who took products containing dicyclomine hydrochloride at doses up to 40 mg/day during the first trimester of pregnancy. Reproduction studies have been performed in rats and rabbits at doses up to 33 times the maximum recommended human dose based on 160 mg/day (3 mg/kg) and have revealed no evidence of harm to the fetus due to dicyclomine.

Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 78 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established. Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [ see Contrainidications (4) ]. There are published cases reporting that the administration of dicyclomine hydrochloride to infants has been followed by serious respiratory symptoms (dyspnea, shortness of breath, breathlessness, respiratory collapse, apnea and asphyxia), seizures, syncope, pulse rate fluctuations, muscular hypotonia, and coma, and death, however; no causal relationship has been established.

🧓 Geriatric Use 113 words ▾

8.5Geriatric Use Clinical studies of dicyclomine hydrochloride 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 in adults, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

🆘 Overdosage ~1 min read ▾

10 OVERDOSAGE In case of an overdose, patients should contact a physician, poison control center (1-800-222-1222), or emergency room. The signs and symptoms of overdosage include: headache; nausea; vomiting; blurred vision; dilated pupils; hot, dry skin; dizziness; dryness of the mouth; difficulty in swallowing; and CNS stimulation including convulsion. A curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis).

One reported event included a 37-year-old who reported numbness on the left side, cold fingertips, blurred vision, abdominal and flank pain, decreased appetite, dry mouth, and nervousness following ingestion of 320 mg daily (four 20 mg tablets four times daily). These events resolved after discontinuing the dicyclomine. The acute oral LD50 of the drug is 625 mg/kg in mice.

The amount of drug in a single dose that is ordinarily associated with symptoms of overdosage or that is likely to be life-threatening, has not been defined. The maximum human oral dose recorded was 600 mg by mouth in a 10-month-old child and approximately 1500 mg in an adult, each of whom survived. In three of the infants who died following administration of dicyclomine hydrochloride [ see Warnings and Precautions (5) ], the blood concentrations of drug were 200, 220, and 505 ng/mL.

It is not known if dicyclomine hydrochloride is dialyzable. Treatment should consist of gastric lavage, emetics, and activated charcoal. Sedatives (e.g., short-acting barbiturates, benzodiazepines) may be used for management of overt signs of excitement.

If indicated, an appropriate parenteral cholinergic agent may be used as an antidote.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Dicyclomine relieves smooth muscle spasm of the gastrointestinal tract. Animal studies indicate that this action is achieved via a dual mechanism: a specific anticholinergic effect (antimuscarinic) at the acetylcholine-receptor sites with approximately 1/8 the milligram potency of atropine ( in vitro , guinea pig ileum); and a direct effect upon smooth muscle (musculotropic) as evidenced by dicyclomine’s antagonism of bradykinin- and histamine-induced spasms of the isolated guinea pig ileum.

Atropine did not affect responses to these two agonists. In vivo studies in cats and dogs showed dicyclomine to be equally potent against acetylcholine (ACh)- or barium chloride (BaCl2)-induced intestinal spasm while atropine was at least 200 times more potent against effects of ACh than BaCl2. Tests for mydriatic effects in mice showed that dicyclomine was approximately 1/500 as potent as atropine; antisialagogue tests in rabbits showed dicyclomine to be 1/300 as potent as atropine.

12.2Pharmacodynamics Dicyclomine hydrochloride can inhibit the secretion of saliva and sweat, decrease gastrointestinal secretions and motility, cause drowsiness, dilate the pupils, increase heart rate, and depress motor function.

12.3Pharmacokinetics Absorption and Distribution In man, dicyclomine is rapidly absorbed after oral administration, reaching peak values within 60 to 90 minutes. Mean volume of distribution for a 20 mg oral dose is approximately

3.65L/kg suggesting extensive distribution in tissues. Elimination The metabolism of dicyclomine was not studied. The principal route of excretion is via the urine (79.5% of the dose).

Excretion also occurs in the feces, but to a lesser extent (8.4%). Mean half-life of plasma elimination in one study was determined to be approximately 1.8 hours when plasma concentrations were measured for 9 hours after a single dose. In subsequent studies, plasma concentrations were followed for up to 24 hours after a single dose, showing a secondary phase of elimination with a somewhat longer half-life.

🧬 Mechanism of Action 148 words ▾

12.1Mechanism of Action Dicyclomine relieves smooth muscle spasm of the gastrointestinal tract. Animal studies indicate that this action is achieved via a dual mechanism: a specific anticholinergic effect (antimuscarinic) at the acetylcholine-receptor sites with approximately 1/8 the milligram potency of atropine ( in vitro , guinea pig ileum); and a direct effect upon smooth muscle (musculotropic) as evidenced by dicyclomine’s antagonism of bradykinin- and histamine-induced spasms of the isolated guinea pig ileum.

Atropine did not affect responses to these two agonists. In vivo studies in cats and dogs showed dicyclomine to be equally potent against acetylcholine (ACh)- or barium chloride (BaCl2)-induced intestinal spasm while atropine was at least 200 times more potent against effects of ACh than BaCl2. Tests for mydriatic effects in mice showed that dicyclomine was approximately 1/500 as potent as atropine; antisialagogue tests in rabbits showed dicyclomine to be 1/300 as potent as atropine.

📦 How Supplied / Storage and Handling 65 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Dicyclomine Hydrochloride Oral Solution, USP 10 mg/5 mL is supplied as a light pink colored, fruit punch flavored solution, free from visible particulate matter in bottles of 473 mL (16 fl. oz.). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from excessive heat. Dispense in a tight container with a child-resistant closure. NDC 70954-261-10

📋 Description 126 words ▾

11 DESCRIPTION Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage form: Dicyclomine Hydrochloride Oral Solution, USP contains 10 mg dicyclomine hydrochloride, USP in each 5 mL (1 teaspoonful). Dicyclomine Hydrochloride Oral Solution, USP also contains inactive ingredients: glycerin, methylparaben, propylene glycol, propylparaben, purified water, noncrystallizing sorbitol solution, sucrose, saccharin sodium with FD&C Red No. 3, FD&C Red No.

40 colors and fruit punch flavor. Dicyclomine hydrochloride is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride, with a molecular formula of C19H35NO2•HCl and the following structural formula: Molecular weight: 345.95 Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether. structure

💬 Information for Patients 174 words ▾

17 PATIENT COUNSELING INFORMATION

17.2Use in Infants Inform parents and caregivers not to administer dicyclomine hydrochloride in infants less than 6 months of age [ see Use in Specific Populations (8.4) ].

17.3Use in Nursing Mothers Advise lactating women that dicyclomine hydrochloride should not be used while human milk feeding their infants [ see Use in Specific Populations (8.3,8.4) ].

17.4Peripheral and Central Nervous System In the presence of a high environmental temperature, heat prostration can occur with dicyclomine hydrochloride use (fever and heat stroke due to decreased sweating). If symptoms occur, the drug should be discontinued and a physician contacted. Dicyclomine hydrochloride may produce drowsiness or blurred vision.

The patient should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery or to perform hazardous work while taking dicyclomine hydrochloride [ see Warnings and Precautions (5.3) ]. Trademarks are the property of their respective owners. Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor New Jersey 08520.

Issued: 04/2021 LB4246-01

🍼 Nursing Mothers 69 words ▾

8.3Nursing Mothers Dicyclomine hydrochloride is contraindicated in women who are human milk feeding. Dicyclomine hydrochloride is excreted in human milk. Because of the potential for serious adverse reactions in human breastfed infants from dicyclomine hydrochloride, 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 [ see Use in Specific Populations (8.4) ].

🧬 Pharmacokinetics 128 words ▾

12.3Pharmacokinetics Absorption and Distribution In man, dicyclomine is rapidly absorbed after oral administration, reaching peak values within 60 to 90 minutes. Mean volume of distribution for a 20 mg oral dose is approximately

3.65L/kg suggesting extensive distribution in tissues. Elimination The metabolism of dicyclomine was not studied. The principal route of excretion is via the urine (79.5% of the dose).

Excretion also occurs in the feces, but to a lesser extent (8.4%). Mean half-life of plasma elimination in one study was determined to be approximately 1.8 hours when plasma concentrations were measured for 9 hours after a single dose. In subsequent studies, plasma concentrations were followed for up to 24 hours after a single dose, showing a secondary phase of elimination with a somewhat longer half-life.

🧬 Pharmacodynamics 29 words ▾

12.2Pharmacodynamics Dicyclomine hydrochloride can inhibit the secretion of saliva and sweat, decrease gastrointestinal secretions and motility, cause drowsiness, dilate the pupils, increase heart rate, and depress motor function.

🔬 Clinical Studies 50 words ▾

14 CLINICAL STUDIES In controlled clinical trials involving over 100 patients who received drug, 82% of patients treated for functional bowel/irritable bowel syndrome with dicyclomine hydrochloride at initial doses of 160 mg daily (40 mg four times daily) demonstrated a favorable clinical response compared with 55% treated with placebo (p<0.05).

🧪 Nonclinical Toxicology 46 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis & Mutagenesis & Impairment Of Fertility Long-term animal studies have not been conducted to evaluate the carcinogenic potential of dicyclomine. In studies in rats at doses of up to 100 mg/kg/day, dicyclomine produced no deleterious effects on breeding, conception, or parturition.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 43 words ▾

13.1Carcinogenesis & Mutagenesis & Impairment Of Fertility Long-term animal studies have not been conducted to evaluate the carcinogenic potential of dicyclomine. In studies in rats at doses of up to 100 mg/kg/day, dicyclomine produced no deleterious effects on breeding, conception, or parturition.

📄 Package Label / Principal Display Panel 13 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Dicyclomine Hydrochloride Oral Solution, USP 10 mg/5 mL label

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
12.6K
Units reimbursed last 4 qtrs
2.4M
Gross reimbursed last 4 qtrs
$443.9K
Avg / prescription
$35.23
Avg / unit
$0.1880
Latest quarter Q1 2026
3.4KRx
Medicaid pays / mL
$0.1880
gross reimbursed
vs
NADAC / mL
$0.1736
acquisition cost
=
Spread
+$0.0144
+8% 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 ⓘ
29% FFS 71% MCO
Fee-for-service · 3,604 Rx Managed care · 8,996 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 3,652 units · 46.7 per 100k residents 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: 22,343 units · 223 per 100k residents MI New York: 77,241 units · 395 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 26,886 units · 842 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 28,368 units · 226 per 100k residents IL Indiana: 118,554 units · 1,728 per 100k residents IN Ohio: 175,100 units · 1,486 per 100k residents OH Pennsylvania: 127,932 units · 987 per 100k residents PA New Jersey: 57,401 units · 618 per 100k residents NJ Massachusetts: 67,473 units · 964 per 100k residents MA California: 294,136 units · 755 per 100k residents CA Utah: no data reported UT Colorado: 22,947 units · 390 per 100k residents CO Nebraska: 6,955 units · 352 per 100k residents NE Missouri: 14,790 units · 239 per 100k residents MO Kentucky: 16,212 units · 358 per 100k residents KY West Virginia: 3,296 units · 186 per 100k residents WV Virginia: 88,567 units · 1,016 per 100k residents VA Maryland: 38,656 units · 626 per 100k residents MD Connecticut: 44,090 units · 1,219 per 100k residents CT Rhode Island: 24,570 units · 2,244 per 100k residents RI Arizona: 37,242 units · 501 per 100k residents AZ New Mexico: 11,151 units · 527 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 20,444 units · 287 per 100k residents TN North Carolina: 107,215 units · 990 per 100k residents NC South Carolina: 20,867 units · 388 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 52,511 units · 1,148 per 100k residents LA Mississippi: 12,629 units · 430 per 100k residents MS Alabama: 44,119 units · 864 per 100k residents AL Georgia: 131,796 units · 1,195 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 442,918 units · 1,452 per 100k residents TX Florida: 158,019 units · 699 per 100k residents FL
Units reimbursed · per 100k residents
46.72,244
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 Rhode Island 2,244 /100k
2 Indiana 1,728 /100k
3 Ohio 1,486 /100k
4 Texas 1,452 /100k
5 Connecticut 1,219 /100k
6 Georgia 1,195 /100k
7 Louisiana 1,148 /100k
8 Virginia 1,016 /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.
← 70954-0258-10 · ANI 70954-0264-10 · ANI →
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.