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Dicyclomine Hydrochloride 10 mg Capsule, 90-count — NDC 62135-0718-90 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Dicyclomine Hydrochloride 10 mg Capsule, 90-count — NDC 62135-718-90 (Billing 62135-0718-90)

by Chartwell RX, LLC · 90 CAPSULE in 1 BOTTLE

This is a package of 90 capsules of Dicyclomine Hydrochloride 10 mg Capsule from Chartwell RX, LLC, marketed since Sep 1974 and currently FDA-listed; retail pharmacies pay about $0.0778 per capsule (NADAC). It is this product's only package size.

NDC 62135-0718-90
🏷️ FDA NDC (as labeled) 62135-718-90 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

⚠️
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) 62135-718-90
Product NDC 62135-718
11-digit billing NDC 62135071890
NCPDP billing unit EA — each (per item)
RxCUI 991061, 991086
UNII CQ903KQA31
UPC 0362135428129, 0362135428013, 0362135718909
Application # ANDA084285
SPL Set ID d628ac1c-404d-45eb-8aab-0e550c95ed4a
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 1974-09-30
Route ORAL
Dosage form CAPSULE
Substance DICYCLOMINE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 49103010100105
GCN Seq No 004918
GCN 19261
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 CAPSULE
FDB brand name Dicyclomine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 004918
  • GCN: 19261
  • GPI-14 (Medi-Span): 49103010100105
  • HICL (First Databank): 002045
  • AHFS class code: 12:08.08.00
  • RxCUI (RxNorm): 991061
Why two NDCs? The FDA registers this code as 62135-718-90 — 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 → 62135-0718-90. 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 CAPSULE 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 eaPer package
Retail pharmacies payNADAC · weekly $0.078 $7.00 / 90 capsules
Medicaid paysCMS SDUD · 12 mo $0.2229 $20.06 / 90 capsules
Medicare drug plans payPart D · Q2 2026 $0.1535 $13.82 / 90 capsules
NADAC price history (per ea) — tap or hover for the price & month
Dec 2023 Jan 2026 May 2026 Sep 2026 $0.123 $0.075
▼ Down 37% over the last 13 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
62135-0718-90 You're viewing this Main listing 90 CAPSULE in 1 BOTTLE 2023-07-26 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dicyclomine hydrochloride 10 mg 00054-0748-25 Hikma 100 capsules $0.078 AB Availability likely —
Dicyclomine Hydrochloride 10 mg 00527-0586-01 Lannett 100 capsules $0.078 AB Availability likely —
Dicyclomine Hydrochloride 10 mg 00591-0794-01 Actavis 100 capsules $0.078 AB Availability likely —
Dicyclomine hydrochloride 10 mg 00832-6053-10 Upsher-Smith 1000 capsules $0.078 AB Discontinued —
Dicyclomine Hydrochloride 10 mg 00904-6987-61 Major 100 capsules $0.078 AB Availability likely —
Dicyclomine Hydrochloride 10 mg 16571-0260-01 Rising 100 capsules $0.078 AB Availability likely —
Dicyclomine Hydrochloride 10 mg 24979-0201-01 Upsher-Smith 100 capsules $0.078 AB Availability likely —
Dicyclomine hydrochloride 10 mg 31722-0052-01 Camber 100 capsules $0.078 AB Availability likely —
Dicyclomine hydrochloride 10 mg 43547-0634-10 Solco 100 capsules $0.078 AB Availability likely —
Dicyclomine Hydrochloride 10 mg 50268-0199-15 AvPAK 50 capsules $0.078 AB Availability likely —
Dicyclomine Hydrochloride 10 mg 59651-0719-01 Aurobindo 100 capsules $0.078 AB Availability likely —
Dicyclomine Hydrochloride 10 mg 60687-0369-01 American 100 capsules $0.078 AB Availability likely —
Dicyclomine Hydrochloride 10 mgthis 62135-0718-90 Chartwell 90 capsules $0.078 AB Availability likely —
Dicyclomine Hydrochloride 10 mg 73473-0800-01 Solaris 100 capsules $0.078 AB Availability likely —
Dicyclomine hydrochloride 10 mg 00615-8483-39 NCS 30 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 42708-0160-56 QPharma, 56 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 43063-0112-04 PD-Rx 4 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 43063-0629-28 PD-Rx 28 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 50090-0126-00 A-S 30 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 50090-0127-00 A-S 30 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 50090-7340-00 A-S 30 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 50090-7341-01 A-S 28 capsules — AB FDA listed —
Dicyclomine hydrochloride 10 mg 50090-7729-00 A-S 30 capsules — AB FDA listed —
Dicyclomine hydrochloride 10 mg 51407-0783-01 Golden 100 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 51655-0219-27 Northwind 12 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 55154-3565-00 Cardinal 10 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 55154-8183-00 Cardinal 10 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 55289-0923-20 PD-Rx 20 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 55700-0766-30 Quality 30 capsules — AB Discontinued —
Dicyclomine Hydrochloride 10 mg 63187-0196-30 Proficient 30 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 66267-0291-30 NuCare 30 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 67046-1258-03 Coupler 30 capsules — AB FDA listed —
Dicyclomine hydrochloride 10 mg 67046-1513-03 Coupler 30 capsules — AB FDA listed —
Dicyclomine hydrochloride 10 mg 67296-2158-03 Redpharm 30 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 68071-3035-03 NuCare 30 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 68071-3310-01 NuCare 16 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 68071-3674-03 NuCare 30 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 68788-8578-01 Preferred 100 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 70518-4331-00 REMEDYREPACK 30 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 70518-4432-00 REMEDYREPACK 30 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 71205-0428-15 Proficient 15 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 71335-0471-01 Bryant 30 capsules — AB Discontinued —
Dicyclomine Hydrochloride 10 mg 71335-0938-01 Bryant 30 capsules — AB Discontinued —
Dicyclomine Hydrochloride 10 mg 71335-2316-01 Bryant 30 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 71335-9709-01 Bryant 30 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 71610-0265-09 Aphena 9000 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 72162-2613-00 Bryant 1000 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 72789-0522-01 PD-Rx 100 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 72789-0546-28 PD-Rx 28 capsules — AB FDA listed —
Dicyclomine hydrochloride 10 mg 72888-0105-00 Advagen 1000 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 67296-2310-03 Redpharm 30 capsules — AB FDA listed —
dicyclomine hydrochloride 10 mg 00054-0883-25 Hikma 100 capsules — AB 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

🏛️
1974
On the market since
Sep 1974
📍
2026
Currently FDA-listed
52 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.

What it looks like

Color blue
ShapeRound
ImprintLAN;1282
Size7 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

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

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerChartwell RX, LLC
Application holderLANNETT CO INC
FDA applicationANDA084285 (ANDA)
Labeler code62135
First marketedSep 1974
Product typeHuman Prescription Drug
Portfolio521 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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 39 words ▾

1 INDICATIONS AND 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 189 words ▾

2 DOSAGE AND 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 63 words ▾

3 DOSAGE FORMS AND STRENGTHS Dicyclomine Hydrochloride Capsules, USP 10 mg: blue capsules with a white powder fill, imprinted logo LANNETT on the cap and 0586 on the body Dicyclomine Hydrochloride Tablets USP, 20 mg: blue, round, flat-faced, beveled edge tablets, debossed LAN over 1282 Dicyclomine Hydrochloride Capsules, USP 10 mg ( 3 ) Dicyclomine Hydrochloride Tablets USP, 20 mg ( 3 )

⛔ Contraindications 158 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 and delirium have been reported in patients sensitive to anticholinergic drugs (such as elderly patients and/or in patients with mental illness): 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 confusional state, disorientation, amnesia, hallucinations, dysarthria, ataxia, coma, euphoria, fatigue, insomnia, agitation and mannerisms, and inappropriate affect. Psychosis and delirium have been reported in sensitive individuals (such as elderly patients and/or in patients with mental illness) 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.

5.4Myasth… [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 Chartwell RX, LLC 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/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 edema, angioedema, anaphylactic shock Nervous system disorders: dizziness, headache, somnolence, syncope Psychiatric disorders: As with the other anti-cholinergic drugs, cases of delirium or symptoms of delirium such as amnesia (or transient global amnesia), agitation, confusional state, delusion, disorientation, hallucination (including visual hallucination) as well as mania, mood altered and pseudodementia, have been reported with the use of Dicyclomine.

Nervousness and insomnia have also been reported. Reproductive system and breast disorders: suppressed lactation Respiratory, thoracic and mediastinal disorders: dyspnoea, nasal congestion Skin and subcutaneous tiss… [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 breastfeeding. Dicyclomine hydrochloride is excreted in human milk. Because of the potential for serious adverse reactions in breast-fed 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 Contraindications ( 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 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.

🆘 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 LD 50 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 (BaCl 2 )-induced intestinal spasm while atropine was at least 200 times more potent against effects of ACh than BaCl 2 . 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 60-90 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.

📦 How Supplied / Storage and Handling 135 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Dicyclomine Hydrochloride Capsules USP, 10 mg 10 mg blue capsules with a white powder fill, imprinted logo LANNETT on the cap and 0586 on the body, supplied in bottles of 90 capsules. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a well-closed container as defined in the USP.

Bottles of 90 capsules: NDC 62135-718-90 Dicyclomine Hydrochloride Tablets USP, 20 mg 20 mg blue, round, flat-faced, beveled edge tablets, debossed LAN over 1282, supplied in bottles of 100 and 120 tablets. To prevent fading, avoid exposure to direct sunlight. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a well-closed container as defined in the USP. Bottles of 100 tablets: NDC 62135-428-01 Bottles of 120 tablets: NDC 62135-428-12

📋 Description 163 words ▾

11 DESCRIPTION Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage forms: Dicyclomine Hydrochloride Capsules, USP for oral use contain 10 mg of dicyclomine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: lactose monohydrate, calcium sulfate, magnesium stearate, gelatin, FD&C Blue No. 1, and FD&C Red No.

3. Dicyclomine Hydrochloride Tablets, USP for oral use contain 20 mg dicyclomine hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: acacia, pregelatinized starch, anhydrous lactose, compressible sugar, dicalcium phosphate, colloidal silicon dioxide, magnesium stearate, stearic acid, and FD & C Blue No.1 Aluminum Lake.

Dicyclomine hydrochloride is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride, with a molecular formula of C 19 H 35 NO 2 •HCl and the following structural formula: 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. Dicyclomine Hydrochloride Structure

💬 Information for Patients 163 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 breastfeeding 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 )] . Manufactured for: Chartwell RX, LLC Congers, NY 10920 L71128 Rev. 07/2023

🔬 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 44 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.

📄 Recent Major Changes 12 words ▾

Warnings and Precautions, Peripheral and Central Nervous System ( 5.3 ) 07/2012

📄 Package Label / Principal Display Panel 43 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Dicyclomine Hydrochloride Capsules, USP 10 mg- NDC 62135-718-90 - 90s Bottle Label Dicyclomine Hydrochloride Tablets, USP 20 mg- NDC 62135-428-01 - 100s Bottle Label Dicyclomine Hydrochloride Tablets, USP 20 mg- NDC 62135-428-12 - 120s Bottle Label dicyclomine-hydrochloride-90s-caps-label dicyclomine-hydrochloride-100s-tabs-label dicyclomine-hydrochloride-120s-tabs-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
15
Units reimbursed last 4 qtrs
956
Gross reimbursed last 4 qtrs
$213.14
Avg / prescription
$14.21
Avg / unit
$0.2229
Latest quarter Q1 2026
0Rx
Medicaid pays / ea
$0.2229
gross reimbursed
vs
NADAC / ea
$0.0778
acquisition cost
=
Spread
+$0.1451
+187% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
100% FFS
Fee-for-service · 15 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 956 units · 4.9 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
4.94.9
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 New York 4.9 /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.
← 62135-0717-26 · Chartwell 62135-0719-90 · Chartwell →
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.