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Atropine Sulfate 10 mg/g Ointment, 1 tube — NDC 24208-0825-55 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Atropine Sulfate 10 mg/g Ointment, 1 tube — NDC 24208-825-55 (Billing 24208-0825-55)

by Bausch & Lomb Incorporated · 1 TUBE in 1 CARTON / 3.5 g in 1 TUBE

This is a package of 1 tube of Atropine Sulfate 10 mg/g Ointment from Bausch & Lomb Incorporated, marketed since Sep 1990 and currently FDA-listed. It is this product's only package size.

NDC 24208-0825-55
🏷️ FDA NDC (as labeled) 24208-825-55 billing pads the product segment with a zero
Rx only 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 24208-825-55 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
24208 labeler · 825 product · 55 package
Package marketed since
Sep 30, 1990
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0324208825556
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Atropine Sulfate (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jul 24, 2026 — Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde (American Regent, Inc.) · FDA recall D-0795-2026
Class I · Dec 21, 2023 — Presence of Particulate Matter; identified as glass (Pfizer Inc.) · FDA recall D-0235-2024
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) 24208-825-55
Product NDC 24208-825
11-digit billing NDC 24208082555
NCPDP billing unit GM — per gram (weight)
RxCUI 1190570
UNII 03J5ZE7KA5
UPC 0324208825556
SPL Set ID c0a56d60-0914-42b1-af59-c56afe93d18c
Established class (EPC) Anticholinergic; Cholinergic Muscarinic Antagonist
Mechanism of action Cholinergic Antagonists; Cholinergic Muscarinic Antagonists
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1990-09-30
Route OPHTHALMIC
Dosage form OINTMENT
Substance ATROPINE SULFATE

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

GPI-14 86350010104210
GPI class Atropine Sulfate
GCN Seq No 007864
GCN 32931
HICL code 002004
Ingredient (HICL) Atropine Sulfate
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6J
Therapeutic class — specific (HIC3) Mydriatics
AHFS code 12:08.08.00
AHFS class Antimuscarinics/Antispasmodics
FDB label name ATROPINE 1% EYE OINTMENT
FDB brand name Atropine Sulfate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 007864
  • GCN: 32931
  • GPI-14 (Medi-Span): 86350010104210
  • HICL (First Databank): 002004
  • AHFS class code: 12:08.08.00
  • RxCUI (RxNorm): 1190570
Why two NDCs? The FDA registers this code as 24208-825-55 — 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 → 24208-0825-55. 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 ATROPINE 1% EYE OINTMENT Ingredient Atropine Sulfate
📖 What it is MedlinePlus · NLM

Ophthalmic atropine is used before eye examinations to dilate (open) the pupil, the black part of the eye through which you see. It is also used to relieve pain caused by swelling and inflammation of the eye.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on the form. The injection is used in emergencies like poisonings and slow heart rhythms, and around surgery to reduce secretions. The eye drops and ointment dilate the...
  • Injections are given by a healthcare professional, usually into a vein. ATROPEN is injected into the outer thigh in an emergency, and you should seek medical care right away. Eye p...
  • Dry mouth, blurred vision, light sensitivity, a faster heartbeat, flushing, dizziness, and constipation are common. These come from atropine's drying effects. Injection site pain c...
  • Seek emergency help for trouble breathing, swelling or a spreading rash, chest pain, a racing or irregular heartbeat, hallucinations, or a high fever with no sweating. Eye pain wit...
📖 Read our full Atropine guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

Price systemPer gPer 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.
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
24208-0825-55 You're viewing this Main listing 1 TUBE in 1 CARTON / 3.5 g in 1 TUBE 1990-09-30 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Atropine Sulfate 10 mg/gthis 24208-0825-55 Bausch 1 tube — — 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

🏛️
1990
On the market since
Sep 1990
📍
2026
Currently FDA-listed
36 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

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

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

Inactive Ingredients / Excipients

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

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

  • UNII OVV5IIJ58F
    Lanolin oil is a waxy substance derived from sheep's wool that acts as an emollient and skin-conditioning agent. It helps soften and smooth the skin while also serving as a moisturizing component in topical formulations.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

4 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

LabelerBausch & Lomb Incorporated
Labeler code24208
First marketedSep 1990
Product typeHuman Prescription Drug
Portfolio92 products on file

More NDCs from Bausch & Lomb Incorporated labeler code 24208

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 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 23 words ▾

INDICATIONS AND USAGE For mydriasis and/or cycloplegia. For cycloplegic refraction, for pupillary dilation desired in inflammatory conditions of the iris and uveal tract.

⏱️ Dosage and Administration 28 words ▾

DOSAGE AND ADMINISTRATION Apply a small amount of ointment to the conjunctival sac once or twice a day, or as directed by a physician. FOR OPHTHALMIC USE ONLY

⛔ Contraindications 57 words ▾

CONTRAINDICATIONS This product should not be used in patients with primary glaucoma or a predisposition to narrow anterior chamber angle glaucoma. This product should not be used in pediatric patients who have previously had a severe systemic reaction to atropine. This product should not be used in those persons showing hypersensitivity to any component of this preparation.

⚠️ Warnings 47 words ▾

WARNINGS In pediatric patients, use with extreme caution. Excessive use in pediatric patients or in certain individuals with a previous history of susceptibility to belladonna alkaloids may produce systemic symptoms of atropine poisoning. If this occurs, discontinue medication and use appropriate therapy as outlined in OVERDOSAGE .

🤒 Adverse Reactions 58 words ▾

ADVERSE REACTIONS Prolonged use may produce local irritation characterized by follicular conjunctivitis, vascular congestion, edema, exudate, and an eczematoid dermatitis. Severe reactions are manifested by hypotension with progressive respiratory depression. Coma and death have been reported in the very young. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🧒 Pediatric Use 7 words ▾

Pediatric Use: See CONTRAINDICATIONS and WARNINGS .

🆘 Overdosage 190 words ▾

OVERDOSAGE Systemic atropine toxicity is manifested by flushing and dryness of the skin (a rash may be present in pediatric patients), blurred vision, a rapid and irregular pulse, fever, abdominal distension in infants, mental aberration (hallucinosis) and loss of neuromuscular coordination. Atropine poisoning, although distressing, is rarely fatal, even with large doses of atropine, and is self-limited if the cause is recognized and the atropine medication is discontinued. In severe intoxication, physostigmine salicylate may be administered parenterally to provide more prompt relief of the intoxication.

Give physostigmine salicylate as 1-5 mL IV of dilution containing 1 mg in 5 mL of saline. The smaller dose is for pediatric patients, and injection should take not less than 2 minutes. EKG control is advisable.

Dosage can be repeated every 5 minutes up to a total dose of 2 mg in pediatric patients and 6 mg in adults every 30 minutes. Physostigmine is contraindicated in hypotensive reactions. Atropine (1 mg) should be available for immediate injection if physostigmine causes bradycardia, convulsions or bronchoconstriction.

In pediatric patients, the body surface must be kept moist. Use extreme caution when employing short-acting barbiturates to control excitement.

🧬 Clinical Pharmacology 38 words ▾

CHEMICAL PHARMACOLOGY The anticholinergic effect of this product blocks the responses of the sphincter muscle of the iris and the accommodative muscle of the ciliary body to cholinergic stimulation, producing pupillary dilation (mydriasis) and paralysis of accommodation (cycloplegia).

📦 How Supplied / Storage and Handling 27 words ▾

HOW SUPPLIED Atropine Sulfate Ophthalmic Ointment, 1% is supplied in an ophthalmic tip applicator tube in the following size: 3.5 g tubes - NDC 24208-825-55 Image 1

📋 Description 75 words ▾

DESCRIPTION: Atropine Sulfate Ophthalmic Ointment, 1% is a sterile topical anticholinergic for ophthalmic use. The active ingredient is represented by the chemical structural formula: (C 17 H 23 NO 3 ) 2 •H 2 SO 4 •H 2 O Mol. Wt.

694.83 Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo-[3.2.1]oct-3-yl ester, endo -(±)-, sulfate (2:1) (salt), monohydrate. Each gram contains: ACTIVE: Atropine Sulfate, 1% (10 mg); INACTIVES: Lanolin oil, mineral oil, purified water, and white petrolatum. chem_structure.jpg

⚠️ Precautions 181 words ▾

PRECAUTIONS To avoid excessive systemic absorption, the lacrimal sac should be compressed by digital pressure for two to three minutes after instillation. To avoid inducing angle closure glaucoma, an estimation of the depth of the angle of the anterior chamber should be made. Administration of atropine in infants requires great caution.

Patient Warning: Patients should be advised not to drive or engage in other hazardous activities while pupils are dilated. Patients may experience sensitivity to light and should protect eyes in bright illumination during dilation. Parents should be warned not to get this preparation in their children’s mouth and to wash their own hands and the child’s hands following administration.

Carcinogenesis, Mutagenesis, Impairment of Fertility: No studies have been conducted in animals or in humans to evaluate the potential of these effects. Animal reproduction studies have not been performed with atropine. It is also not known whether atropine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Atropine should be given to pregnant women only if clearly needed. Pediatric Use: See CONTRAINDICATIONS and WARNINGS .

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 64 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility: No studies have been conducted in animals or in humans to evaluate the potential of these effects. Animal reproduction studies have not been performed with atropine. It is also not known whether atropine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Atropine should be given to pregnant women only if clearly needed.

📄 Package Label / Principal Display Panel 27 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 24208-825-55 Atropine Sulfate Ophthalmic Ointment, 1% (Sterile) FOR OPHTALMIC USE ONLY Rx only Net. Wt. 1/8 oz. (3.5g) BAUSCH + LOMB carton

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Atropine Sulfate — the program that covers self-administered drugs. 7 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Atropine Sulfate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$2.44M
Claims incl. refills
57.2K
Beneficiaries
42.2K
Spend / beneficiary
$57.89
Spend / claim
$42.70
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 Bausch & Lomb Incorporated. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bausch & Lomb Incorporated 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.
← 24208-0816-05 · Bausch 24208-0830-60 · Bausch →
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.