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Donnatal phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide 16.2 mg/5mL; .1037 mg/5mL; .0194 mg/5mL; .0065 mg/5mL Elixir, 118 mL — NDC 59212-0422-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Donnatal phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide 16.2 mg/5mL; .1037 mg/5mL; .0194 mg/5mL; .0065 mg/5mL Elixir, 118 mL — NDC 59212-422-04 (Billing 59212-0422-04)

by Advanz Pharma (US) Corp. · 118 mL in 1 BOTTLE

This is a package of 118 mL of Donnatal phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide 16.2 mg/5mL; .1037 mg/5mL; .0194 mg/5mL; .0065 mg/5mL Elixir from Advanz Pharma (US) Corp., marketed since Dec 1980 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 59212-0422-04
🏷️ FDA NDC (as labeled) 59212-422-04 billing pads the product segment with a zero
This package
Contains118 mL Pack sizes3 compare ↓
Main listing for product 59212-422 · Also comes in: 10 ml 59212-422-10 473 ml 59212-422-16
Rx only On market CIV ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 59212-422-04
Product NDC 59212-422
11-digit billing NDC 59212042204
NCPDP billing unit ML — per mL (volume)
RxCUI 1046787, 1046924
UNII 451IFR0GXB, 03J5ZE7KA5, F2R8V82B84, YQE403BP4D
UPC 0359212423047
SPL Set ID 4dba30db-7979-455f-a225-24f0a04d744e
Established class (EPC) Anticholinergic; Cholinergic Muscarinic Antagonist
Mechanism of action Cholinergic Antagonists; Cholinergic Muscarinic Antagonists
DEA schedule CIV
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1980-12-30
Route ORAL
Dosage form ELIXIR
Substance PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE

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

GPI-14 49109904051030
GPI class Donnatal
GCN Seq No 004773
GCN 74040
HICL code 035019
Ingredient (HICL) Phenobarb/Hyoscy/Atropine/Scop
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J2
Therapeutic class — intermediate (HIC2) Anticholinergics
HIC3 code J2A
Therapeutic class — specific (HIC3) Belladonna Alkaloids
AHFS code 12:08.08.00
AHFS class Antimuscarinics/Antispasmodics
FDB label name DONNATAL ELIXIR
FDB brand name Donnatal
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 004773
  • GCN: 74040
  • GPI-14 (Medi-Span): 49109904051030
  • HICL (First Databank): 035019
  • AHFS class code: 12:08.08.00
  • RxCUI (RxNorm): 1046787
Why two NDCs? The FDA registers this code as 59212-422-04 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 59212-0422-04. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Anticholinergic class.

Pharmacologic class Anticholinergic, Cholinergic Muscarinic Antagonist
Drug family (ATC) Belladonna alkaloids, tertiary amines, Anticholinergics, Antidotes
How it works Cholinergic Muscarinic Antagonists, 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 DONNATAL ELIXIR Ingredient Phenobarb/Hyoscy/Atropine/Scop
📖 About the active ingredient MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Belladonna alkaloid combinations and phenobarbital are used to relieve cramping pains in conditions such as irritable bowel syndrome and spastic colon. They also are used with other medicine to treat ulcers. These medicines decrease the motion of the stomach and intestines and the secretion of stomach fluids, including acid. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

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

Donnatal is an oral elixir containing four active ingredients: phenobarbital (a barbiturate sedative), hyoscyamine sulfate and scopolamine hydrobromide (anticholinergic agents), and atropine sulfate (also an anticholinergic). These ingredients are typically combined in products intended to address cramping and digestive discomfort by relaxing smooth muscle in the stomach and intestines, while the barbiturate provides sedation. This product is marketed without an approved FDA application.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 10 ml 473 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
59212-0422-04 You're viewing this Main listing 118 mL in 1 BOTTLE 1980-12-30 — Active
59212-0422-10 59212-422-10 10 mL in 1 BOTTLE 1980-12-30 — Active
59212-0422-16 59212-422-16 473 mL in 1 BOTTLE 1980-12-30 — Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 118 mL — 118 ml in 1 bottle.
How does this package differ from NDC 59212-0422-10?
Both are Donnatal phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide 16.2 mg/5mL; .1037 mg/5mL; .0194 mg/5mL; .0065 mg/5mL Elixir — the drug itself is identical. This page's package is the 118 mL one, while NDC 59212-0422-10 is the 10 ml package.
What NDC number is used to bill for this package of Donnatal phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide 16.2 mg/5mL; .1037 mg/5mL; .0194 mg/5mL; .0065 mg/5mL Elixir?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Phenohytro 16.2 mg/5mL; .1037 mg/5mL; .0194 mg/5mL; .0065 mg/5mL 17856-0125-01 ATLANTIC 72 cups — — FDA listed —
Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide 16.2 mg/5mL; .1037 mg/5mL; .0194 mg/5mL; .0065 mg/5mL 50742-0665-04 Ingenus 118 ml — — FDA listed —
Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide 16.2 mg/5mL; .1037 mg/5mL; .0194 mg/5mL; .0065 mg/5mL 50742-0666-04 Ingenus 118 ml — — FDA listed —
Donnatal 16.2 mg/5mL; .1037 mg/5mL; .0194 mg/5mL; .0065 mg/5mLthis 59212-0422-04 Advanz 118 ml — — FDA listed —
Donnatal 16.2 mg/5mL; .1037 mg/5mL; .0194 mg/5mL; .0065 mg/5mL 59212-0423-04 Advanz 118 ml — — FDA listed —
Donnatal 16.2 mg/5mL; .1037 mg/5mL; .0194 mg/5mL; .0065 mg/5mL 66689-0063-10 VistaPharm, 10 cups — — FDA listed —
Phenohytro 16.2 mg/5mL; .1037 mg/5mL; .0194 mg/5mL; .0065 mg/5mL 75826-0127-04 Winder 118 ml — — FDA listed —
Phenohytro 16.2 mg/5mL; .1037 mg/5mL; .0194 mg/5mL; .0065 mg/5mL 75826-0128-04 Winder 118 ml — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
1980
On the market since
Dec 1980
📍
2026
Currently FDA-listed
46 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

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

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

What it looks like

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

Inactive Ingredients / Excipients

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

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

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII I753WB2F1M
    FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
  • 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 SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII 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.

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

The official label also statesPurified Water, Glycerin, Sorbitol, Ethyl Alcohol, Sucrose, Saccharin Sodium, Artificial and Natural Grape Flavor, FD&C Red #3, and FD&C Blue #1. Purified Water, Glycerin, Sorbitol, Ethyl Alcohol, Sucrose, Saccharin Sodium, Natural Mint Flavor, FD&C Yellow #5, and FD&C Blue #1.

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerAdvanz Pharma (US) Corp.
Labeler code59212
First marketedDec 1980
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio20 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. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 🧪 Inactive Ingredients 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🔒 Drug Abuse and Dependence 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 98 words ▾

INDICATIONS AND USAGE Based on a review of this drug by the National Academy of Sciences-National Research Council and/or other information, FDA has classified the indications as follows: "Possibly" effective: For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. May also be useful as adjunctive therapy in the treatment of duodenal ulcer. Final classification of the less-than-effective indications requires further investigation.

IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ANTISPASMODIC DRUGS AID IN THE HEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS.

⏱️ Dosage and Administration 130 words ▾

DOSAGE AND ADMINISTRATION The dosage of Donnatal® Elixir should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects. Donnatal® Elixir. Adults: One or two teaspoonfuls of elixir three or four times a day according to conditions and severity of symptoms.

Pediatric patients: may be dosed every 4 to 6 hours. Use a pediatric dosing device or oral syringe to measure the dose. Starting Dosage Body weight Every 4 hours Every 6 hours 10 lb.

(4.5 kg) 0.5 mL 0.75 mL 20 lb. (9.1 kg) 1 mL 1.5 mL 30 lb. (13.6 kg) 1.5 mL 2 mL 50 lb.

(22.7 kg) 2.5 mL 3.75 mL 75 lb. (34 kg) 3.75 mL 5 mL 100 lb. (45.4 kg) 5 mL 7.5 mL

⛔ Contraindications 86 words ▾

CONTRAINDICATIONS glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis especially if complicated by toxic megacolon; myasthenia gravis; hiatal hernia associated with reflux esophagitis; in patients with known hypersensitivity to any of the ingredients.

Phenobarbital is contraindicated in acute intermittent porphyria and in those patients in whom phenobarbital produces restlessness and/or excitement.

⚠️ Warnings ~1 min read ▾

WARNINGS Donnatal® Elixir can cause fetal harm when administered to a pregnant woman. Animal reproduction studies have not been conducted with Donnatal® Elixir. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

In the presence of a high environmental temperature, heat prostration can occur with belladonna alkaloids (fever and heatstroke due to decreased sweating). Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful.

Donnatal® Elixir may produce drowsiness or blurred vision. The patient should be warned, should these occur, not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery, and not to perform hazardous work. Phenobarbital may decrease the effect of anticoagulants, and necessitate larger doses of the anticoagulant for optimal effect.

When the phenobarbital is discontinued, the dose of the anticoagulant may have to be decreased. Phenobarbital may be habit forming and should not be administered to individuals known to be addiction prone or to those with a history of physical and/or psychological dependence upon drugs. Since barbiturates are metabolized in the liver, they should be used with caution and initial doses should be small in patients with hepatic dysfunction.

🤒 Adverse Reactions 183 words ▾

ADVERSE REACTIONS Adverse reactions may include xerostomia; urinary hesitancy and retention; blurred vision; tachycardia; palpitation; mydriasis; cycloplegia; increased ocular tension; loss of taste sense; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; musculoskeletal pain; severe allergic reaction or drug idiosyncrasies, including anaphylaxis, urticaria, and other dermal manifestations; and decreased sweating. Acquired hypersensitivity to barbiturates consists chiefly in allergic reactions that occur especially in persons who tend to have asthma, urticaria, angioedema, and similar conditions.

Hypersensitivity reactions in this category include localized swelling, particularly of the eyelids, cheeks, or lips, and erythematous dermatitis. Rarely, exfoliative dermatitis (e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis) may be caused by phenobarbital and can prove fatal.

The skin eruption may be associated with fever, delirium, and marked degenerative changes in the liver and other parenchymatous organs. In a few cases, megaloblastic anemia has been associated with the chronic use of phenobarbital. Phenobarbital may produce excitement in some patients, rather than a sedative effect.

To report SUSPECTED ADVERSE REACTIONS, contact Advanz Pharma (US) Corp. at 1-877-370-1142 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 34 words ▾

Drug Interactions Phenobarbital may decrease the effect of anticoagulants, and necessitate larger doses of the anticoagulant for optimal effect. When the phenobarbital is discontinued, the dose of the anticoagulant may have to be decreased.

🤰 Pregnancy 52 words ▾

Pregnancy Animal reproduction studies have not been conducted with Donnatal® Elixir. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks ( see WARNINGS ).

🧓 Geriatric Use 23 words ▾

Geriatric Use Elderly patients may react with symptoms of excitement, agitation, drowsiness, and other untoward manifestations to even small doses of the drug.

🆘 Overdosage 54 words ▾

OVERDOSAGE The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot and dry skin, dizziness, dryness of the mouth, difficulty in swallowing, and CNS stimulation. Treatment should consist of gastric lavage, emetics, and activated charcoal. If indicated, parenteral cholinergic agents such as physostigmine or bethanechol chloride should be used.

🧬 Clinical Pharmacology 25 words ▾

CLINICAL PHARMACOLOGY This drug combination provides natural belladonna alkaloids in a specific, fixed ratio combined with phenobarbital to provide peripheral anticholinergic/antispasmodic action and mild sedation.

📦 How Supplied / Storage and Handling 122 words ▾

HOW SUPPLIED Donnatal® Elixir - Grape is a purple colored, grape flavored liquid. 4 fl oz (118 mL) bottles- NDC 59212-423-04. 1 Pint (473 mL) bottles- NDC 59212-423-16.

Donnatal® Elixir - Mint is a green colored, mint flavored liquid. 4 fl oz (118 mL) bottles- NDC 59212-422-04. 1 Pint (473 mL) bottles- NDC 59212-422-16.

Avoid Freezing Store Donnatal® Elixir at 20º- 25ºC (68º - 77ºF) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

DEA EXEMPT PRODUCT Manufactured for: Advanz Pharma (US) Corp. Bannockburn, IL 60015 DONNATAL ® is a registered trademark of Mercury Pharma Group Limited. Distributed by Advanz Pharma (US) Corp. under license.

Revised:11/23

🧪 Inactive Ingredients 44 words ▾

Inactive Ingredients Purified Water, Glycerin, Sorbitol, Ethyl Alcohol, Sucrose, Saccharin Sodium, Artificial and Natural Grape Flavor, FD&C Red #3, and FD&C Blue #1.

Inactive Ingredients Purified Water, Glycerin, Sorbitol, Ethyl Alcohol, Sucrose, Saccharin Sodium, Natural Mint Flavor, FD&C Yellow #5, and FD&C Blue #1.

📋 Description 117 words ▾

DESCRIPTION Donnatal ® Elixir - Grape Each 5 mL (teaspoonful) of elixir (alcohol not more than 23.8%) contains: Phenobarbital, USP.............................. 16.2 mg Hyoscyamine Sulfate, USP............... 0.1037 mg Atropine Sulfate, USP......................

0.0194 mg Scopolamine Hydrobromide, USP.... 0.0065 mg Inactive Ingredients Purified Water, Glycerin, Sorbitol, Ethyl Alcohol, Sucrose, Saccharin Sodium, Artificial and Natural Grape Flavor, FD&C Red #3, and FD&C Blue #1.

Donnatal ® Elixir - Mint Each 5 mL (teaspoonful) of elixir (alcohol not more than 23.8%) contains: Phenobarbital, USP.............................. 16.2 mg Hyoscyamine Sulfate, USP............... 0.1037 mg Atropine Sulfate, USP...................... 0.0194 mg Scopolamine Hydrobromide, USP.... 0.0065 mg Inactive Ingredients Purified Water, Glycerin, Sorbitol, Ethyl Alcohol, Sucrose, Saccharin Sodium, Natural Mint Flavor, FD&C Yellow #5, and FD&C Blue #1.

💬 Information for Patients 42 words ▾

Information for Patients Donnatal® Elixir may produce drowsiness or blurred vision. The patient should be warned, should these occur, not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery, and not to perform hazardous work.

⚠️ Precautions ~1 min read ▾

PRECAUTIONS General Use with caution in patients with: autonomic neuropathy hepatic or renal disease hyperthyroidism coronary heart disease congestive heart failure cardiac arrhythmias tachycardia hypertension Belladonna alkaloids may produce a delay in gastric emptying (antral stasis) which would complicate the management of gastric ulcer. Do not rely on the use of the drug in the presence of complication of biliary tract disease. Theoretically, with overdosage, a curare-like action may occur.

Donnatal® Elixir – Mint contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No.

5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. Information for Patients Donnatal® Elixir may produce drowsiness or blurred vision. The patient should be warned, should these occur, not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery, and not to perform hazardous work.

Drug Interactions Phenobarbital may decrease the effect of anticoagulants, and necessitate larger doses of the anticoagulant for optimal effect. When the phenobarbital is discontinued, the dose of the anticoagulant may have to be decreased. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Pregnancy Animal reproduction studies have not been conducted with Donnatal® Elixir. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks ( see WARNINGS ). Nursing Mothers It is not known whether this drug is excreted in human milk.

Because many drugs are excreted in human milk, caution should be exercised when Donnatal® Elixir is administered to a nursing woman. Geriatric Use Elderly patients may react with symptoms of excitement, agitation, drowsiness, and other untoward manifestations to even small doses of the drug.

🍼 Nursing Mothers 35 words ▾

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Donnatal® Elixir is administered to a nursing woman.

🔒 Drug Abuse and Dependence 52 words ▾

DRUG ABUSE AND DEPENDENCE Abuse Phenobarbital may be habit forming and should not be administered to individuals known to be addiction prone or to those with a history of physical and/or psychological dependence upon drugs ( see WARNINGS ). Dependence In patients habituated to barbiturates, abrupt withdrawal may produce delirium or convulsions.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 17 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential.

📄 Package Label / Principal Display Panel 144 words ▾

Principal Display Panel - Donnatal Elixir - Grape, 4 oz NDC 59212-423-04 4 FL OZ Donnatal ® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Elixir grape flavored Each 5 mL (1 teaspoonful) contains: Phenobarbital, USP.............................. 16.2 mg Hyoscyamine Sulfate, USP............... 0.1037 mg Atropine Sulfate, USP......................

0.0194 mg Scopolamine Hydrobromide, USP.... 0.0065 mg Alcohol not more than 23.8% DO NOT USE IF TAMPER-EVIDENT SEAL UNDER CAP IS BROKEN OR MISSING. Rx only 1

Principal Display Panel - Donnatal Elixir - Mint, 4 oz NDC 59212-422-04 4 FL OZ Donnatal ® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Elixir mint flavored Each 5 mL (1 teaspoonful) contains: Phenobarbital, USP.............................. 16.2 mg Hyoscyamine Sulfate, USP............... 0.1037 mg Atropine Sulfate, USP......................

0.0194 mg Scopolamine Hydrobromide, USP.... 0.0065 mg Alcohol not more than 23.8% DO NOT USE IF TAMPER-EVIDENT SEAL UNDER CAP IS BROKEN OR MISSING. Rx only 2

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide — the ingredient across all brands.

Top reported reactions

Pain91
Nausea80
Diarrhoea75
Anxiety60
Abdominal Pain58
Dyspnoea57
Fatigue54

Reporter sex

915 reports
Male · 21%
Female · 79%
Unknown · 0%

Serious outcomes

Death36
Disabling33
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 51 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Advanz Pharma (US) Corp.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 10 ml (59212-0422-10), 473 ml (59212-0422-16). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Advanz Pharma (US) Corp. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 59212-0249-55 · Advanz 59212-0423-04 · Advanz →
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.