FDA.reportPublic FDA data

Atropine Sulfate

Product NDC
24208-825
11-digit product format
242080825
Labeler code
24208
Product ID
24208-825_72b36d2b-77a4-4b9e-b99d-99bf20e45cc5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atropine Sulfate
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1990-09-30
Substance
ATROPINE SULFATE
Active strength
10 mg/g
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Atropine Sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATROPINE SULFATE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
03J5ZE7KA5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1190570Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c0a56d60-0914-42b1-af59-c56afe93d18cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c78bd43-efb4-4aeb-b7d8-eff1532f7822Product name420250801
41231c1e-8789-4da7-ac52-77fa90a85bf5Product name220250304
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0Product name220250214
5f84b7a7-523a-f042-dffb-1dadcd9b2407Product name420240110
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95caProduct name120230719
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0Product name320230317
dfd25202-b8d2-4628-9213-f3e0f9eafce5Product name420210513
4199bf9b-4718-828a-6dd6-ac2fbbd61687Product name120140508
4edd8af5-cea7-ae42-8023-e91c5335db1dProduct name120140508
d3908afb-7784-440f-c406-88294732d36aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24208-825-55Atropine Sulfate1 in 1 CARTONOINTMENT18
24208-825-55Atropine Sulfate3.5 g in 1 TUBEOINTMENT3.58

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-825-55GM - Gram24208-825e15946a9-0511-4ff9-b916-4756e1f0d25612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA5ATROPINE SULFATE OINTMENT [BAUSCH & LOMB INCORPORATED]3
ATROPINEACTIVE MOIETY7C0697DR9IATROPINE SULFATE OINTMENT [BAUSCH & LOMB INCORPORATED]3
LANOLIN OILINACTIVE INGREDIENTOVV5IIJ58FATROPINE SULFATE OINTMENT [BAUSCH & LOMB INCORPORATED]3
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPATROPINE SULFATE OINTMENT [BAUSCH & LOMB INCORPORATED]3
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UATROPINE SULFATE OINTMENT [BAUSCH & LOMB INCORPORATED]3
WATERINACTIVE INGREDIENT059QF0KO0RATROPINE SULFATE OINTMENT [BAUSCH & LOMB INCORPORATED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-825ATROPINE SULFATE OINTMENT [BAUSCH & LOMB INCORPORATED]8Current NDC, Legacy NDC, 2 package rows20231230_c0a56d60-0914-42b1-af59-c56afe93d18c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atropine SulfateATROPINE SULFATEBausch & Lomb Incorporatedc0a56d60-0914-42b1-af59-c56afe93d18c2020-04-02Warnings, Adverse reactionsExact identifier
ndc (product): 24208-825

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190570atropine sulfate 1 % Ophthalmic OintmentPSNc0a56d60-0914-42b1-af59-c56afe93d18c8
1190570atropine sulfate 0.01 MG/MG Ophthalmic OintmentSCDc0a56d60-0914-42b1-af59-c56afe93d18c8
1190570atropine sulfate 1 % Ophthalmic OintmentSYc0a56d60-0914-42b1-af59-c56afe93d18c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24208-825-55242080825551 TUBE in 1 CARTON (24208-825-55) / 3.5 g in 1 TUBE1 tube1990-09-300000-00-00NoNoCurrent